In short
Clinical trials are studying HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST TROP2 CONJUGATED TO N-((7S,15S)-7-BENZYL-17-(((1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL-10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12H-BENZO[DE]PYRANO[3',4':6,7] INDOLIZINO[1,2-B]QUINOLIN-1-YL)AMINO)-15-METHYL-2,5,8,11,17-PENTAOXO-14-OXA-3,6,9,12-TETRAAZAHEPTADECYL)-6-(2,5-DIOXO-2,5-DIHYDRO-1H-PYRROL-1-YL)HEXANAMIDE in people with advanced or metastatic solid tumors. The trials aim to check safety, tolerability, and early signs of benefit, including the best dose to use in combination studies.
Key points
- Clinical trials are studying HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST TROP2 CONJUGATED TO N-((7S,15S)-7-BENZYL-17-(((1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL-10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12H-BENZO[DE]PYRANO[3',4':6,7] INDOLIZINO[1,2-B]QUINOLIN-1-YL)AMINO)-15-METHYL-2,5,8,11,17-PENTAOXO-14-OXA-3,6,9,12-TETRAAZAHEPTADECYL)-6-(2,5-DIOXO-2,5-DIHYDRO-1H-PYRROL-1-YL)HEXANAMIDE in advanced or metastatic solid tumors. The trial is Phase 2 and is authorised, with 409 participants planned. It includes people with NSCLC, cervical cancer, melanoma, hepatocellular carcinoma, ovarian cancer, and squamous cell carcinoma of the head and neck. The main goals are to find a recommended dose, check safety and tolerability, and measure early tumor response. Key outcomes include dose limiting toxicities, treatment-emergent adverse events, serious adverse events, and objective response rate.
Clinical trials overview
The available trial is an interventional Phase 2 study of HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST TROP2 CONJUGATED TO N-((7S,15S)-7-BENZYL-17-(((1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL-10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12H-BENZO[DE]PYRANO[3',4':6,7] INDOLIZINO[1,2-B]QUINOLIN-1-YL)AMINO)-15-METHYL-2,5,8,11,17-PENTAOXO-14-OXA-3,6,9,12-TETRAAZAHEPTADECYL)-6-(2,5-DIOXO-2,5-DIHYDRO-1H-PYRROL-1-YL)HEXANAMIDE in advanced or metastatic solid tumors.1
The study is authorised and plans to enroll 409 participants.1
Who the trials are for
This study targets people with advanced or metastatic solid tumors, which means cancers that have grown locally or spread to other parts of the body.1
The listed cancer types are non-small cell lung cancer, cervical cancer, melanoma, hepatocellular carcinoma, ovarian cancer, and squamous cell carcinoma of the head and neck.1
Study design and phases
The trial is split into two parts.1 In Part 1, the main goal is to find the recommended Phase 2 dose, which is the dose chosen for later study based on safety results.1
Part 1 also checks safety and tolerability in the targeted participant groups, using dose limiting toxicities, treatment-emergent adverse events, and treatment-emergent serious adverse events.1
In Part 2, the study looks at efficacy, which means how well the treatment works, in targeted participant populations.1
Part 2 includes arms that study HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST TROP2 CONJUGATED TO N-((7S,15S)-7-BENZYL-17-(((1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL-10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12H-BENZO[DE]PYRANO[3',4':6,7] INDOLIZINO[1,2-B]QUINOLIN-1-YL)AMINO)-15-METHYL-2,5,8,11,17-PENTAOXO-14-OXA-3,6,9,12-TETRAAZAHEPTADECYL)-6-(2,5-DIOXO-2,5-DIHYDRO-1H-PYRROL-1-YL)HEXANAMIDE with BNT327 and DB-1305, including randomized dose optimization arms.1
What the trials measure
The main safety endpoint in Part 1 is the number of participants with dose limiting toxicities, or side effects that help define the highest safe dose.1
The study also measures treatment-emergent adverse events and treatment-emergent serious adverse events in both parts of the trial.1
The main efficacy endpoint in Part 2 is objective response rate (ORR), which is the proportion of participants with a confirmed complete response or partial response as their best overall response.1
ORR is measured using RECIST v1.1, a standard rule set for checking how tumors change on scans.1
Key patient-focused points
- These trials focus on advanced cancers, so they are aimed at people whose disease is already far along.1
- The study is not only about safety; it also looks for early signs that the treatment combinations may help control cancer.1
- The trial includes several cancer types, so it is a multi-cancer study rather than one limited to a single disease.1
- The randomized dose optimization arm is used to help choose the best dose for further testing.1