Study on dazostinag & pembrolizumab for advanced solid tumors

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    What is this study about?

    The purpose of this study is to test a new drug called dazostinag. A study is being conducted to see whether this drug is helpful in adults with advanced forms of solid cancer. Some people are given dazostinag alone, while others are given it with another medicine called pembrolizumab. Scientists’ focus here is on finding out whether these drugs cause any side effects, and finding out what the maximum dose is that people can take without serious side effects. The study consists of two parts, including a dose escalation phase and a dose escalation phase. In the first part, the dose of dazostinag will be gradually increased, given alone or in combination with pembrolizumab. In the second part, Dazostinag will be tested with pembrolizumab and other anticancer drugs. This section will focus on patients with specific cancers that are difficult to remove or have spread to other parts of the body.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Wels , Austria

      Salzburg , Austria

      Wiener Neustadt , Austria

      Edegem , Belgium

      Leuven , Belgium

      Suresnes , France

      Vandu0153uvre-les-Nancy , France

      Besancon , France

      Bordeaux , France

      Caen , France

      Dijon , France

      Lille , France

      Lyon , France

      Marseille , France

      Paris , France

      St Herblain , France

      Villejuif , France

      Bydgoszcz , Poland

      Warsaw , Poland

      Sutton , United Kingdom

      Belfast , United Kingdom

      Leeds , United Kingdom

      London , United Kingdom

      London , United Kingdom

      Manchester , United Kingdom

      Oxford , United Kingdom

      You can join this study in:

      : !!dwa.

      Netherlands: ‘s-Gravenhage, ‘s-Hertogenbosch, Alkmaar, Almelo, Almere, Amersfoort, Amsterdam, Apeldoorn, Arnhem, Beek, Bergen op Zoom, Beverwijk, Breda, Delft, Deventer, Dirksland, Doetinchem, Dordrecht, Ede, Eindhoven, Enschede, Geleen, Goes, Gouda, Groningen, Haarlem, Harderwijk, Heemstede, Heerlen, Heeze, Helmond, Hilversum, Hoofddorp, Hoogeveen, Hoorn, Leeuwarden, Leiden, Leiden, RC, Leiderdorp, Maastricht, Nieuwegein, Nijmegen, Roermond, Roosendaal, Rotterdam, Sneek, Terneuzen, The Hague, Tiel, Tilburg, Uden, Utrecht, Veldhoven, Venlo, Zaandam, Zutphen, Zwolle.

      Spain: A Coruña, Albacete, Alcalá de Henares, Alcobendas, Alcorcón, Alcoy, Algeciras, Alicante, Almería, Alzira, Ávila, Badajoz, Badalona, Barakaldo, Barcelona, Benalmádena, Bilbao, Boadilla del Monte, Buenos Aires, Burgos, Burjassot, Cáceres, Cádiz, Cartagena, Castellón de la Plana, Castilleja de la Cuesta, Collado Villalba, Córdoba, Coslada, Elche, Esplugues de Llobregat, Ferrol, Fuenlabrada, Galdakao, Gandia, Getafe, Getxo, Gijón, Girona, Granada, Huelva, Jaén, Jerez de la Frontera, L’Hospitalet de Llobregat, Laredo, Las Palmas de Gran Canaria, León, Lleida, Lugo, Madrid, Majadahonda, Málaga, Manises, Manresa, Marbella, Mérida, Móstoles, Murcia, Ourense, Oviedo, Palma, Pamplona, Parla, Ponferrada, Pontevedra, Pozuelo de Alarcón, Puerto De Sagunto, Reus, Rincón de la Victoria, Sabadell, Salamanca, Salt, San Cristóbal de La Laguna, San Pedro Alcántara, San Sebastián, San Sebastián de los Reyes, Sant Adrià de Besòs, Sant Andreu de La Barca, Sant Cugat del Vallès, Sant Cugat del Vallès, Sant Joan d’Alacant, Sant Joan Despí, Santa Cruz de Tenerife, Santander, Santiago de Compostela, Saragossa, Segovia, Seville, Talavera de la Reina, Terrassa, Teruel, Toledo, Tomelloso, Torrejón de Ardoz, Torrevieja, Valencia, Valladolid, Vigo, Villajoyosa, Villamartin, Villareal, Vitoria, Xàtiva, Zamora.

      Denmark: Aabenraa, Aalborg, Aarhus, Copenhagen, Esbjerg, Frederiksberg, Gandrup, Glostrup, Hellerup, Herlev, Herning, Holbæk, Holstebro, Hvidovre, Køge, Kolding, Næstved, Odense, Roskilde, Slagelse, Søborg, Sønderborg, Svendborg, Vejle, Viborg.

      Germany: Aachen, Altenburg, Ansbach, Aschaffenburg, Augsburg, Bad Abbach, Bad Bentheim, Bad Berka, Bad Bramstedt, Bad Doberan, Bad Friedrichshall, Bad Homburg vor der Höhe, Bad Krozingen, Bad Nauheim, Bad Oeynhausen, Bad Reichenhall, Bad Saarow, Bad Schönborn, Bad Soden, Baden, Bamberg, Bayreuth, Bergisch Gladbach, Berlin, Bielefeld, Bitburg, Blankenfelde-Mahlow, Böblingen, Bochum, Bonn, Bottrop, Bramsche, Brandenburg an der Havel, Braunschweig, Bremen, Buxtehude, Chemnitz, Cloppenburg, Coburg, Cologne, Coswig, Cottbus, Dachau, Darmstadt, Datteln, Deggendorf, Deggingen, Delitzsch, Dessau-Roßlau, Donauwörth, Dortmund, Dresden, Duisburg, Dülmen, Düsseldorf, Eggenfelden, Eichstätt, Elsterwerda, Erbach im Odenwald, Erding, Erfurt, Erkelenz, Erlangen, Eschweiler, Essen, Esslingen am Neckar, Flensburg, Frankfurt, Freiburg im Breisgau, Friedrichshafen, Friedrichsthal, Fulda, Fürstenwalde, Fürth, Garmisch-Partenkirchen, Gauting, Geesthacht, Geilenkirchen, Gelnhausen, Georgsmarienhütte, Gera, Giessen, Goch, Gommern, Görlitz, Göttingen, Greifswald, Großhansdorf, Gütersloh, Haar, Hagen, Halle, Hamburg, Hamm, Hanau, Hanover, Heidelberg, Heilbronn, Heinsberg, Hemer, Herne, Hildesheim, Hochheim am Main, Hohenmölsen, Homburg, Hoppegarten, Höxter, Idar-Oberstein, Immenhausen, Immenstadt im Allgäu, Jena, Jerichow, Kaiserslautern, Karlsruhe, Kassel, Kehl, Kempten, Kiel, Kirchheim unter Teck, Koblenz, Konstanz, Krefeld, Kronach, Lahr, Landsberg am Lech, Landshut, Langen, Langenau, Lebach, Leipzig, Lemgo, Leverkusen, Limburg, Lingen, Löhne, Löwenstein, Lübeck, Lüdenscheid, Ludwigsburg, Ludwigshafen, Lüneburg, Magdeburg, Mainz, Mannheim, Marburg, Markkleeberg, Mayen, Memmingen, Merseburg, Meschede, Mettmann, Minden, Moers, Mönchengladbach, Mörfelden-Walldorf, Munich, Münnerstadt, Münster, Mutlangen, Naunhof, Neu-Isenburg, Neumünster, Neuruppin, Neuss, Nordhausen, Northeim, Nuremberg, Nürtingen, Offenbach am Main, Offenburg, Oldenburg, Oldenburg In Holstein, Osnabrück, Paderborn, Papenburg, Passau, Peine, Pforzheim, Pirna, Planegg, Pohlheim, Potsdam, Quedlinburg, Radeberg, Ratingen, Ravensburg, Recklinghausen, Regensburg, Remscheid, Rendsburg, Reutlingen, Rheine, Riesa, Rodewisch, Rosenheim, Rostock, Rüdersdorf, Rüsselsheim am Main, Saarbrücken, Saarlouis, Sande, Sankt Augustin, Schleswig, Schönau am Königssee, Schönebeck, Schwäbisch Hall, Schweinfurt, Schwerin, Selters, Siegburg, Siegen, Simmern, Sindelfingen, Singen, Solingen, Speyer, Stade, Stendal, Stralsund, Stuhr, Stuttgart, Suhl, Sulzbach-Rosenberg, Templin, Torgau, Traunstein, Trier, Troisdorf, Tübingen, Tuttlingen, Ulm, Unterhaching, Velbert, Villingen-Schwenningen, Wallerfing, Wangen im Allgäu, Weiden in der Oberpfalz, Wermsdorf, Wertheim, Wesel, Westerstede, Wiesbaden, Wipperfürth, Witten, Wolfenbüttel, Wolfsburg, Worms, Wuppertal, Würselen, Würzburg, Zwickau.

      Belgium: Aalst, Alken, Anderlecht, Antwerp, Arlon, Ath, Beerzel, Belgium, Beuzet, Bonheiden, Bouge, Brasschaat, Bruges, Brussels, Charleroi, Dendermonde, Edegem, Esneux, Genk, Ghent, Haine-Saint-Paul, Ham-sur-Heure-Nalinnes, Hamme-Mille, Hasselt, Jette, Kortrijk, Leuven, Libramont-Chevigny, Liège, Lier, Linkebeek, Loverval, Lubbeek, Mechelen, Melsbroek, Mol, Mons, Montigny-le-Tilleul, Namur, Noirefontaine, Ostend, Ottignies-Louvain-la-Neuve, Overpelt, Pelt, Roeselare, Saint-Nicolas, Sint-Niklaas, Thuin, Tienen, Tournai, Tubiza, Turnhout, Verviers, West Flanders, Wilrijk, Woluwe-Saint-Lamber, Yvoir, Zaventem.

      United Kingdom: Aberdeen, Airdrie, Barnsley, Barry, Basingstoke, Bath, Bebington, Bedford, Belfast, Bellshill, Birmingham, Blackburn, Blackpool, Bournemouth, Bradford, Brighton and Hove, Bristol, Burton upon Trent, Bury Saint Edmunds, Cambridge, Cannock, Canterbury, Cardiff, Chelmsford, Cheltenham, Chesterfield, Chichester, Chinnor, Chippenham, Chorley, Clydebank, Coatbridge, Colchester, Corby, Cottingham, Coventry, Craigavon, Derby, Doncaster, Dudley, Dundee, Durham, East Kilbride, Eastleigh, Edinburgh, Exeter, Felixstowe, Frimley, Gillingham, Glasgow, Gloucester, Gorleston-on-Sea, Great Yarmouth, Guildford, Hackensack, Harefield, Harlow, Harrow, Hexham, High Wycombe, Hoddesdon, Honiton, Huddersfield, Inverness, Ipswich, Isleworth, Keighley, King’s Lynn, Kingston upon Hull, Lancaster, Leamington Spa, Leeds, Leicester, Lincoln, Liskeard, Liverpool, London, Londonderry, Luton, Macclesfield, Maidstone, Manchester, Middlesbrough, Motherwell, Nantwich, Newcastle upon Tyne, Newmarket, Newquay, Northampton, Norwich, Nottingham, Oswestry, Oxford, Penarth, Penzance, Perth, Peterborough, Plymouth, Poole, Portsmouth, Prescot, Preston, Reading, Redhill, Rhyl, Rochdale, Romford, Rotherham, Salford, Sheffield, Shipley, South Shields, Southampton, Stafford, Stanmore, Stevenage, Stockport, Stockton-on-Tees, Stoke-on-Trent, Sunderland, Sutton, Sutton Coldfield, Sutton-in-Ashfield, Swansea, Swinton, Taunton, Thetford, Torquay, Trowbridge, Truro, Wakefield, Walsall, Warwick, Watford, West Yorkshire, Westbury-on-Trym, Westcliff-on-Sea, Wigan, Winchester, Windsor, Wirral, Wishaw, Withington, Wolverhampton, Wrexham, Wythenshawe, Yate, Yeovil, York.

      Italy: Acquaviva delle Fonti, Alessandria, Ancona, Arezzo, Arzignano, Ascoli Piceno, Avellino, Aviano, Baggiovara, Bari, Bassano del Grappa, Battipaglia, Bellaria – Igea Marina, Bergamo, Bologna, Bolzano, Borgo San Lorenzo, Brescia, Brindisi, Busto Arsizio, Cagliari, Candiolo, Carpi, Carrara, Casatenovo, Caserta, Cassino, Castelfranco Veneto, Castellana Grotte, Catania, Catanzaro, Cefalù, Chieti, Como, Cona, Cosenza, Cremona, Cuneo, Empoli, Faenza, Ferrara, Florence, Foggia, Foligno, Genoa, Grosseto, Gussago, L’Aquila, La Spezia, Lecco, Legnago, Livorno, Lucca, Macerata, Mantua, Massa, Meldola, Messina, Milan, Mirano, Misterbianco, Modena, Monopoli, Monserrato, Montichiari, Monza, Naples, Negrar di Valpolicella, Novara, Orbassano, Padua, Palermo, Parma, Pavia, Perugia, Pesaro, Pescara, Peschiera del Garda, Piacenza, Pietra Ligure, Pisa, Pistoia, Ponderano, Ponte San Pietro, Pordenone, Pozzilli, Pozzuoli, Prato, Ranica, Ravenna, Reggio Calabria, Reggio Emilia, Rho, Rimini, Rionero in Vulture, Rivoli, Rome, Rozzano, Salerno, San Donato Milanese, San Giovanni Rotondo, Sassari, Siena, Sondrio, Statte, Telese Terme, Terni, Torrette, Tradate, Trento, Treviglio, Treviso, Tricase, Trieste, Turin, Udine, Varese, Venice, Vercelli, Verduno, Verona, Vicenza, Viterbo.

      France: Aix-en-Provence, Amiens, Angers, Annecy, Annonay, Antony, Argenteuil, Ars-Laquenexy, Aurillac, Avignon, Bayonne, Beauvais, Besançon, Bobigny, Bois-Guillaume, Bondy, Bordeaux, Boulogne-Billancourt, Boulogne-sur-Mer, Bourg-en-Bresse, Brest, Bron, Caen, Cahors, Caluire-et-Cuire, Cannes, Chambéry, Chambray-lès-Tours, Cholet, Clamart, Clermont-Ferrand, Clichy, Colmar, Colombes, Compiègne, Corbeil-Essonnes, Creil, Créteil, Dax, Dijon, Douai, Dunkirk, Épagny-Metz-Tessy, Garches, Gières, Gonesse, Grenoble, Hyères, La Roche-sur-Yon, La Rochelle, La Tronche, Laquenexy, Le Chesnay, Le Coudray, Le Havre, Le Kremlin-Bicêtre, Le Mans, Le Plessis-Robinson, Le Puy-en-Velay, Libourne, Lille, Limoges, Loos, Lorient, Lyon, Marseille, Martigues, Maubeuge, Meaux, Mont-de-Marsan, Montauban, Montfermeil, Montivilliers, Montpellier, Morlaix, Mougins, Mulhouse, Nancy, Nantes, Neuilly-sur-Seine, Nice, Nîmes, Orléans, Oullins-Pierre-Bénite, Paris, Pau, Perpignan, Pessac, Pierre-Bénite, Plérin, Poissy, Poitiers, Pontoise, Pringy, Quimper, Quint-Fonsegrives, Reims, Rennes, Rodez, Romans-sur-Isère, Roubaix, Rouen, Saint-Brieuc, Saint-Cloud, Saint-Denis, Saint-Étienne, Saint-Grégoire, Saint-Herblain, Saint-Malo, Saint-Mandé, Saint-Ouen-sur-Seine, Saint-Pierre, Saint-Priest-en-Jarez, Saint-Quentin, Salouël, Strasbourg, Suresnes, Toulon, Toulouse, Tours, Trévenans, Vaillant, Val-de-Marne, Valence, Valenciennes, Vannes, Vantoux, Villefranche-sur-Saône, Villejuif, Villeurbanne.

      Portugal: Alcabideche, Almada, Amadora, Aveiro, Braga, Carnaxide, Cascais, Coimbra, Covilhã, Creixomil e Mariz, Faro, Figueira da Foz, Funchal, Guarda, Guimarães, Leiria, Lisbon, Loures, Matosinhos, Paço de Arcos, Ponte De Lima, Portimão, Porto, Porto Covo, Santa Maria da Feira, Senhora da Hora, Setúbal, Torres Novas, Torres Vedras, Viana do Castelo, Vila Nova de Gaia, Vila Nova de Gaia, Vila Real.

      Norway: Ålesund, Bærum, Bergen, Bodø, Drammen, Fredrikstad, Gjøvik, Kalnes, Kristiansand, Lørenskog, Moss, Oslo, Sarpsborg, Skedsmokorset, Stavanger, Tønsberg, Tromsø, Trondheim.

      Greece: Alexandroupolis, Athens, Chaidari, Chortiatis, Corfu, Efkarpia, Exochi, Goudi, Haidari, Heraklion, Holargos, Ioannina, Kallithea, Larissa, Marousi, Mytilene, Nea Ionia, Patras, Piraeus, Pylaia-Chortiatis, Rio, Thessaloniki, Volos.

      Romania: Arad, Bacău, Baia Mare, Bragadiru, Brăila, Brașov, Bucharest, Buzău, Câmpulung, Caracal, Cluj-Napoca, Constanța, Craiova, Deva, Florești, Galați, Hunedoara, Iași, Mangalia, Oradea, Otopeni, Ovidiu, Pitești, Ploiești, Reșca, Sângeorgiu de Mureș, Satu Mare, Sibiu, Suceava, Târgu Mureș, Timișoara.

      Austria: Bad Dürrnberg, Bad Ischl, Bludenz, Braunau am Inn, Bregenz, Eisenstadt, Feldbach, Feldkirch, Graz, Grieskirchen, Innsbruck, Klagenfurt am Wörthersee, Krems an der Donau, Kufstein, Leoben, Linz, Multiple Locations, Rankweil, Salzburg, Sankt Pölten, Sankt Veit an der Glan, Schwaz, Steyr, Stockerau, Vienna, Vöcklabruck, Wals-Siezenheim, Wels, Wiener Neustadt, Zams.

      Hungary: Baja, Balassagyarmat, Balatonfüred, Békéscsaba, Budapest, Csorna, Debrecen, Deszk, Edelény, Eger, Encs, Farkasgyepű, Gödöllő, Gyöngyös, Gyöngyössolymos, Győr, Gyula, Hajdúnánás, Hatvan, Kaposvár, Kistarcsa, Komárom, Mátraháza, Miskolc, Monor, Mosonmagyaróvár, Nyíregyháza, Orosháza, Pécs, Püspökladány, Salgótarján, Sellye, Százhalombatta, Szeged, Székesfehérvár, Szekszárd, Szigetvár, Szolnok, Szombathely, Tatabánya, Törökbálint, Vác, Veszprém, Zalaegerszeg.

      Slovakia: Banská Bystrica, Bardejov, Bojnice, Bratislava, Brezno, Dubnica nad Váhom, Kežmarok, Kláštor pod Znievom, Košice, Levice, Liptovský Mikuláš, Lučenec, Malacky, Martin, Michalovce, Moldava nad Bodvou, Námestovo, Nitra, Nové Zámky, Partizánske, Piešťany, Poprad, Púchov, Rimavská Sobota, Rožňava, Ružomberok, Sabinov, Spišská Nová Ves, Šurany, Svidník, Topoľčany, Trebišov, Trenčín, Trnava, Žilina, Zvolen.

      Poland: Będzin, Bełchatów, Biała Podlaska, Białystok, Bielsko-Biała, Brzozów, Bydgoszcz, Bystra, Bytom, Chęciny, Chełm, Chojnice, Chorzów, Chrzanów, Częstochowa, Dąbrowa Górnicza, Elbląg, Gdańsk, Gdynia, Giżycko, Gliwice, Grodzisk Mazowiecki, Grudziądz, Gryfice, Grzepnica, Inowrocław, Iwonicz-Zdrój, Jelenia Góra, Józefów, Karczew, Katowice, Kędzierzyn Koźle, Kielce, Kłodzko, Knurów, Kobylniki, Konin, Kościan, Koszalin, Ksawerów, Łańcut, Łęczna, Legnica, Leszno, Łódź, Łowicz, Lubin, Lublin, Malbork, Mikołów, Mysłowice, Nadarzyn, Nowa Sól, Nowy Sącz, Nowy Targ, Olsztyn, Opole, Osielsko, Ossy, Ostróda, Ostrowiec Świętokrzyski, Oświęcim, Otwock, Piaseczno, Piła, Piotrków Trybunalski, Poland, Poznań, Prabuty, Przemyśl, Puławy, Racibórz, Radom, Rybnik, Rzeszów, Siedlce, Skarżysko-Kamienna, Skawina, Skierniewice, Skórzewo, Słupsk, Sochaczew, Sopot, Sosnowiec, Środa Wielkopolska, Staszów, Strzelce Opolskie, Świdnica, Szczecin, Szklarska Poręba, Sztum, Tarnów, Tarnowskie Góry, Toruń, Trzebnica, Tychy, Ustroń, Wadowice, Wałbrzych, Warsaw, Wejherowo, Wieliszew, Włocławek, Wrocław, Zabrze, Zamość, Zawadzkie, Zgierz, Żory.

      Czechia: Benešov, Beroun, Bílina, Bílovec, Boskovice, Brandýs nad Labem-Stará Boleslav, Brno, Broumov, České Budějovice, Choceň, Chomutov, Havířov, Havlíčkův Brod, Holešov, Hořovice, Hradec Králové, Jablonec nad Nisou, Jihlava, Jílové u Prahy, Jindřichův Hradec, Klatovy, Klecany, Kolín, Krnov, Kroměříž, Kutná Hora, Kyjov, Liberec, Litovel, Louny, Lovosice, Měšice, Miroslav, Mladá Boleslav, Náchod, Nové Město, Novu00e1 Ves Pod Pleu0161u00ed, Nový Bor, Nový Jičín, Olomouc, Opava, Ostrava, Pardubice, Pilsen, Písek, Polička, Prague, Příbram, Prostějov, Rokycany, Slaný, Slezská Ostrav, Strakonice, Svitavy, Teplice, Trinec, Trutnov, Ústí nad Labem, Varnsdorf, Vsetín, Zlín.

      Bulgaria: Blagoevgrad, Botevgrad, Branipole, Burgas, Cherven Bryag, Dimitrovgrad, Dobrich, Dupnitsa, Gabrovo, Gorna Oryahovitsa, Haskovo, Kardzhali, Kozloduy, Lovech, Montana, Panagyurishte, Pazardzhik, Pernik, Petrich, Pleven, Plovdiv, Razgrad, Ruse, Sevlievo, Shumen, Silistra, Sliven, Smolyan, Sofia, Stara Zagora, Troyan, Tsarev Brod, Varna, Veliko Tarnovo, Velingrad, Vidin, Vratsa.

      Sweden: Borås, Botkyrka, Danderyd, Eskilstuna, Falun, Gävle, Gothenburg, Halmstad, Helsingborg, Huddinge, Jönköping, Kalmar, Karlstad, Kristianstad, Lidingö, Linköping, Luleå, Lund, Malmö, Mölndal, Mölnlycke, Motala, Örebro, Östersund, Rättvik, Skövde, Solna, Stockholm, Sundsvall, Trollhättan, Umeå, Uppsala, Varberg, Växjö.

      Slovenia: Celje, Golnik, Jesenice, Kamnik, Ljubljana.

      Albania: Durrës, Elbasan, Korçë, Tirana.

      Finland: Espoo, Hämeenlinna, Helsinki, Järvenpää, Kokkola, Kuopio, Lahti, Oulu, Pori, Seinäjoki, Tampere, Turku, Vaasa.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The clinical trial you are inquiring about consists of the following steps for participants:

      1. Dose Escalation Phase:
        • Safety Lead-in: This initial part starts with Dazostinag single agent (SA) at 0.1 milligram (mg).
        • Part 1A: Dazostinag doses increase from 0.2 mg and above.
        • Part 1B: The combination of Dazostinag, with escalating doses starting at 0.2 mg, along with Pembrolizumab.
        • Japan Safety Lead-in: Dazostinag SA at 5.0 mg and Pembrolizumab. More dose levels such as 3.5 mg or 7.0 mg and higher may be explored.
      2. Dose Expansion Phase: Once a safe dose is recommended from Part 1, patients will be placed in specific cohorts based on their disease:
        • Part 2A (SCCHN CPS ≥ 1 Dose Expansion Phase): Dazostinag plus Pembrolizumab.
        • Part 2B (SCCHN Dose Expansion Phase): Dazostinag plus Pembrolizumab with Chemotherapy.
        • Part 3A (Expansion Phase in CRC for MSI-H/dMMR): Dazostinag plus Pembrolizumab.
        • Part 3B (Expansion Phase in CRC for MSS/pMMR): Dazostinag plus Pembrolizumab. Dose optimization will be performed in either this part or Part 2A.

      The overall time to participate in this study is 62.9 months.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible to join the study based on diseases, you need to have:

      1. A histologically confirmed (cytological diagnosis is acceptable) advanced or metastatic solid tumor that has no standard therapeutic options available or for which you are intolerant to these therapies.
      2. In the case of combination with pembrolizumab (during dose escalation Parts 1B and Japan safety lead-in), the tumors should be either:
        • Relapsed or refractory to anti-programmed cell death ligand protein 1 (anti PD-(L)-1) therapy, or
        • Tumors that are naive to anti-PD-(L)-1 therapy.
      3. For the expansion phase only, participants with metastatic or recurrent, unresectable Squamous Cell Carcinoma of the Head and Neck (SCCHN) that is considered incurable by local therapies.

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria:

      1. Age ≥ 18 years at the time of consent.
      2. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
      3. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
      4. Diagnosis of metastatic or recurrent Triple Negative Breast Cancer (TNBC). TNBC is a type of breast cancer that is not supported by the hormones estrogen and progesterone, nor by the presence of too many HER2 receptors. Therefore, TNBC does not respond to hormonal therapy medicines or medicines that target HER2.
      5. Prior treatment with an anthracycline and/or a taxane in any setting unless contraindicated. Anthracyclines and taxanes are classes of chemotherapy drugs used in cancer treatment.
      6. Documented evidence of tumor progression on or after the most recent therapy.
      7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. ECOG performance status is a scale used to determine the patient’s level of functioning in terms of self-care, daily activity, and physical ability.
      8. Measurable disease according to RECIST 1.1. RECIST (Response Evaluation Criteria in Solid Tumors) is a set of published rules that define when cancer patients improve (“respond”), stay the same (“stable”), or worsen (“progress”) during treatments.
      9. Adequate organ and marrow function.
      10. Left Ventricular Ejection Fraction (LVEF) ≥ 50% as determined by echocardiogram (ECHO) or multigated acquisition scan (MUGA). LVEF is a measurement of how much blood the left ventricle pumps out with each contraction.
      11. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
        • Not a woman of childbearing potential (WOCBP)
        • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after the last dose of study treatment.
      12. Patient is willing and able to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Patients for whom newly obtained samples cannot be provided (e.g. inaccessible or risk to patient outweighs the benefit of biopsy) may submit an archived specimen only upon agreement from the Sponsor.

      What Reasons Could Exclude Me from the Study?

      Based on the exclusion criteria provided, here is a list with explanations of some medical terms:

      1. Corrected QT interval (QTcF) abnormalities: The QT interval on an electrocardiogram (ECG) represents part of the electrical cycle of the heart during a beat. An abnormal corrected QT interval (greater than 450 milliseconds for men or greater than 475 milliseconds for women) can indicate a higher risk of heart arrhythmias.
      2. Hypotension of a certain severity: Low blood pressure (specifically Grade ≥ 2) requiring nonurgent intervention. Grades are a way to classify the severity of symptoms, with higher numbers indicating more serious conditions.
      3. Low oxygen saturation: If the oxygen levels in the blood (measured by saturation) are less than 92% while breathing room air, it can indicate a problem with lung function or oxygen exchange.
      4. Previous treatments with certain drugs: Treatment in the last 6 months with STING (Stimulator of Interferon Genes) agonists/antagonists or toll-like receptors agonists, which are drugs that can influence immune responses.
      5. Respiratory or lung conditions: Current or previous conditions such as pneumonitis, interstitial lung disease, severe obstructive pulmonary disease, idiopathic pulmonary fibrosis, and other serious lung diseases that impair respiratory function.
      6. Brain metastases: Having brain or leptomeningeal (affecting the layers covering the brain) metastases, unless these have been stable or improved for at least 6 weeks after treatment and the patient is not on corticosteroids.
      7. Ongoing infection or fever: An existing Grade ≥ 2 infection or fever associated with cancer which indicates an ongoing serious illness.
      8. Chronic viral hepatitis: Active hepatitis B or hepatitis C infection, judged by certain blood markers.
      9. Use of certain medications: Medications known as OATP1B1/OATP1B3 inhibitors, which can affect drug metabolism, should not have been used within 14 days before the first dose of study drug.
      10. Vaccinations: Receipt of live attenuated vaccines, like those for tuberculosis, polio, rotavirus, or yellow fever, within 28 days of the first study drug dose due to the potential for interference with the immune response.
      11. Stem cell or organ transplantation recipients: Individuals who have received allogeneic (from another person) or autologous (self-donated) stem cell or organ transplants are excluded due to altered immune function.
      12. Other malignancies: Having another malignancy within the past 2 years with certain exceptions, as these might interfere with study outcomes or pose additional risks.
      13. Known metabolic conditions: Known deficiency in dihydropyrimidine dehydrogenase (DPD) or mutations in the thymidine phosphorylase gene (TYMP), which can affect the metabolism of certain chemotherapy drugs (applies to Part 2B of the study only).

      For any clarifications regarding these conditions or their relevance to your personal health, please consult with your healthcare provider.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Dazostinag: This drug is being tested to treat people who have advanced or metastatic solid tumors. Dazostinag is given as an infusion, intravenously (IV), with doses escalating from 0.2 mg and above during the trial.
      2. Pembrolizumab (active substance: pembrolizumab): Pembrolizumab is an immunotherapy drug used in cancer treatment. It is a monoclonal antibody that blocks the PD-1 pathway, enhancing the immune response against cancer cells. In this study, pembrolizumab 200 mg is administered IV, once every 3 weeks (Q3W) in combination with Dazostinag.

      Please note that the study includes various phases where these drugs are administered separately or in combination, and different dosages of Dazostinag may be explored based on safety data.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances participating in the clinical trial and their known statuses in medicine and the medical literature are:

      1. Dazostinag (TAK-676) – This is a drug being tested in this clinical trial as an intravenous infusion. It appears to be a novel substance, as there is no description provided of its previous acceptance in medicinal use or presence in medical literature within the trial document.
      2. Pembrolizumab – A well-known and established drug in the medical literature used for various types of cancer, also administered as an intravenous infusion. It is an immune checkpoint inhibitor, specifically a PD-1 blocking antibody, and has been approved for medical use in several conditions.
      3. Platinum (as Carboplatin or Cisplatin) – These are established chemotherapy drugs used for treating various types of cancers. Both carboplatin and cisplatin are widely known in medical literature and used clinically for their cytotoxic effects on cancer cells.
      4. 5-fluorouracil (5-FU) – This is a chemotherapy medication used to treat various types of cancer. It is a well-known drug in medical literature and has been used in medicine for many years as an intravenous infusion.

      Study ID

      CT-EU-00054054

      Recruitment status

      Recruting new patients

      Start of the trial

      4 years ago

      Study phase

      Phase
      I