Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Phase I/II Study Evaluating Safety and Preliminary Efficacy of JJP-1008 in Adults with Advanced Unresectable Melanoma and Other Solid Tumors

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial involves people with Advanced, Unresectable Skin Melanoma and other solid tumors. These are cancers that cannot be removed by surgery and have spread to other parts of the body. The investigational medicine is JJP-1008, given as an intravenous infusion (a fluid that goes directly into a vein). It may be used alone (monotherapy) or together with an immune checkpoint inhibitor, a type of drug that helps the immune system recognize cancer.

The purpose of the study is to evaluate the safety, tolerability, immune response and early signs of effectiveness of JJP-1008. The trial is divided into several parts that first find the highest dose that can be given safely (called the maximum tolerated dose) and the recommended dose for further testing. Later parts confirm these doses and look for early evidence that the drug may shrink tumors.

Participants will receive the study drug through a short IV infusion at regular clinic visits. Doctors will check vital signs, heart tests, blood work and physical exams to watch for any side effects, which are called adverse events. Special attention will be paid to reactions that happen during the infusion, known as infusion‑related reactions. Tumor size will be measured using standard imaging criteria (RECIST) to see if the cancer is responding. Blood samples may be taken to study how the drug behaves in the body and whether the immune system produces antibodies against it.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessments

    After joining the study, you will undergo a series of baseline examinations to record your health status before treatment begins.

    These examinations include blood tests, urine tests, an electrocardiogram (ECG) to check heart rhythm, imaging scans of the tumor, and a performance‑status assessment using the ECOG PS scale.

    The results provide a reference point for later safety and effectiveness evaluations.

  2. Step 2

    First Intravenous Infusion of JJP‑1008

    You will receive the study drug JJP‑1008 as an intravenous infusion. The medication is supplied as a concentrate for solution for infusion.

    The exact dose is determined by the study protocol and may be adjusted during the dose‑finding phase (Part A) to identify the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).

    The infusion is administered in a clinical setting where healthcare staff monitor you throughout the procedure.

  3. Step 3

    Monitoring for Immediate Reactions

    During and shortly after the infusion, you will be observed for any infusion‑related reactions (IRRs) such as fever, chills, or changes in blood pressure.

    Vital signs (heart rate, blood pressure, temperature, breathing rate) are checked regularly, and any symptoms are recorded.

  4. Step 4

    Ongoing Treatment Cycles

    You will receive additional infusions of JJP‑1008 on the schedule defined by the study, typically every two weeks, although the exact interval may vary according to the protocol.

    In Part A, the dose may be gradually increased in small groups of patients to find the MTD or RP2D. Once the appropriate dose is identified, the same dose is used for the remaining cycles.

    Treatment continues for a predefined number of cycles, or until disease progression, unacceptable side effects, or withdrawal from the study.

  5. Step 5

    Regular Safety Evaluations

    At each visit you will have blood and urine tests, an ECG, and a physical examination to detect any new or worsening side effects.

    Healthcare professionals will assess the severity of any treatment‑emergent adverse events (TEAEs) and report serious events (TESAEs) to the study team.

    These assessments help determine whether the medication remains safe for you to continue.

  6. Step 6

    Efficacy Assessments

    Imaging studies such as CT or MRI scans are performed at scheduled intervals to measure changes in tumor size.

    Tumor response is evaluated using the RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) or iRECIST guidelines, which classify results as complete response, partial response, stable disease, or progression.

    These results provide an early indication of how well the drug is working.

  7. Step 7

    Combination Therapy Phase (Part C)

    If you are assigned to Part C, JJP‑1008 will be given together with an immune checkpoint inhibitor (ICI), a type of medication that helps the immune system recognize cancer cells.

    The same infusion schedule, safety monitoring, and efficacy assessments apply, with additional observation for any interactions between the two drugs.

  8. Step 8

    End of Treatment

    Treatment ends when you have completed the planned number of infusions, when the disease progresses, or if side effects become intolerable.

    You will have a final set of safety and efficacy evaluations to document the outcome of the study medication.

  9. Step 9

    Follow‑Up Period

    After treatment stops, you will continue to attend scheduled follow‑up visits for several months.

    These visits focus on long‑term safety, overall survival, and any delayed side effects.

    The follow‑up schedule is defined by the study protocol and may include periodic imaging and laboratory tests.

Who can join the trial?

16 criteria

  • Informed consent: Agree to join the study by signing a written consent form.
  • Have a life expectancy that meets the study’s definition (the doctors think you have enough time to complete the study).
  • Be at least 18 years old.
  • Have a body mass index (BMI) less than 40 kg/m² (BMI is a measure of weight relative to height).
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (a scale that shows how well you can carry out daily activities; 0 = fully active, 1 = restricted but able to do light work).
  • Have adequate hematologic function (blood health) as defined by the study (your blood counts are within safe ranges).
  • Have adequate hepatic function (liver health) as defined by the study (your liver tests are within safe ranges).
  • Have adequate renal function (kidney health) as defined by the study (your kidney tests are within safe ranges).
  • Use effective birth control during the study and for a period after treatment ends: women who could become pregnant must use highly effective contraception; men with partners who could become pregnant must use a double barrier method and ensure their partners also use effective contraception or have had a vasectomy.
  • Agree not to donate sperm or eggs while taking the study drug and for a period after treatment ends.
  • Be willing and able to follow all study procedures and provide written consent.
  • Have a confirmed diagnosis (by tissue examination) of one of the listed cancers (melanoma, kidney cancer, liver cancer, non‑small cell lung cancer, small cell lung cancer, gastric cancer, esophageal cancer, gastric‑esophageal junction cancer, breast cancer, microsatellite‑stable colorectal cancer, bladder cancer, or prostate cancer) with disease that is spreading or cannot be treated with standard local therapy.
  • For parts B and C, have a confirmed diagnosis of melanoma, colon, gastric, lung or other solid tumors previously studied in part A, with disease that is stage III (locally advanced) or stage IV (metastatic) and not curable by local treatment or standard systemic therapy.
  • Have disease that has gotten worse after all standard treatment options that could help you, unless those treatments are not suitable for you (for example, because of side effects). For patients with BRAF‑mutated melanoma, you may join without prior BRAF/MEK inhibitor therapy only if that therapy was not appropriate for you.
  • Provide a new tissue sample (biopsy) if you have melanoma; for other cancers a biopsy is optional if it can be safely obtained. An older biopsy taken within 60 days after stopping previous treatment may be used.
  • Have disease that can be measured on imaging (CT or MRI) according to RECIST v1.1 or iRECIST criteria: for parts B and C you need at least one measurable tumor; for part A, even non‑measurable but evaluable disease is allowed.

Who cannot join the trial?

25 criteria

  • You have had a severe allergic reaction (called hypersensitivity) to other laboratory‑made antibodies (known as monoclonal antibodies).
  • You received chemotherapy, targeted cancer pills, experimental drugs, or radiation therapy too recently (usually within the last 2‑4 weeks, or longer depending on the drug’s lasting time in the body).
  • You had major surgery or a serious injury within the past 4 weeks, or you have not fully recovered from such an event if it was more than 4 weeks ago.
  • You have another active cancer (besides the skin melanoma being studied), except for certain early‑stage skin cancers or bladder/cervical cancers that were fully treated, within the last 24 months.
  • You have an untreated brain tumor or central nervous system cancer. (Only stable brain metastases that have been treated and are off steroids may be allowed.)
  • You have taken medicines that suppress the immune system in the past month, or you are on high‑dose steroids (more than 10 mg of prednisone each day) in the past two weeks.
  • You have an active autoimmune disease (a condition where the immune system attacks the body) that needed strong medication in the past two years.
  • You have an active infection that required treatment through an IV (intravenous) line, such as strong antibiotics, antivirals, or antifungals, within the past two weeks.
  • You have ever received a solid‑organ or tissue transplant from another person.
  • You have had serious heart or blood‑vessel problems within the past 6 months, such as a stroke, heart attack, unstable chest pain (angina), severe heart failure (New York Heart Association class III or higher), or an irregular heartbeat that needed medication.
  • You experienced a major bleeding episode that needed more than two units of blood transfused (not caused by the tumor) within the past year.
  • You have a significant clotting disorder or platelet problem, or you did not respond to platelet transfusions, within the past year.
  • You are infected with HIV and have had a serious opportunistic infection in the past year, or your immune‑system count (called CD4 cells) is below 350 per microliter.
  • You test positive for Hepatitis B surface antigen or core antibody and have detectable Hepatitis B virus DNA in your blood.
  • You test positive for Hepatitis C antibodies and have a measurable amount of Hepatitis C virus RNA in your blood.
  • You still have side effects from previous cancer treatment that are moderate or worse (grade 2 or higher), except for mild nerve problems, hair loss, or hormone problems that are controlled with medication.
  • You are currently pregnant or breastfeeding.
  • You are known to be allergic or intolerant to any of the inactive ingredients (called excipients) in the study drug JJP‑1008.
  • You have a serious other illness that could threaten your life or make it hard to follow the study rules, and the doctor thinks it would be unsafe for you to join.
  • You have had your spleen removed (a procedure called splenectomy).
  • You have eye (ocular) melanoma or any type of melanoma that is not skin‑derived.
  • If you are being considered for the part of the study that adds an immune‑checkpoint inhibitor (ICI), you are allergic or intolerant to that ICI or its inactive ingredients.
  • You have a history of lung scarring diseases such as idiopathic pulmonary fibrosis, organizing pneumonia, drug‑induced pneumonitis, or any active lung inflammation seen on a chest CT scan.
  • You previously received immunotherapy that had to be stopped because of a severe immune‑related side effect.
  • You have received a live vaccine (such as measles, mumps, rubella, or varicella) within the past 30 days.
Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • JJP-1008

    is an investigational drug being tested for the first time in people with advanced skin melanoma and other solid tumors. It is given through an IV (intravenous) line as a liquid that is mixed with fluid and infused into the bloodstream. The trial is looking at how safe it is, how well patients tolerate it, whether the body creates any immune response against it, and if it shows any early signs of shrinking tumors when used alone.

  • Immune checkpoint inhibitor (ICI)

    is a type of cancer therapy that helps the body’s own immune system recognize and attack cancer cells. In this study, the ICI is used together with JJP-1008 to see if the combination works better than JJP-1008 alone. The ICI is given according to standard practice for this class of drugs, and the trial will monitor safety, tolerability, and any improvement in tumor response when both treatments are used together.

What is already known about the treatment

JJP-1008 - JJP-1008 is given as an intravenous concentrate that is mixed with fluid and infused into a vein; it is currently an experimental drug being studied for the first time in humans and is not yet approved for any use. The drug is being tested for patients with advanced, unresectable skin melanoma and other solid tumors. It works by helping the body’s immune system recognize and attack cancer cells, acting as an immunotherapy that modulates immune signaling. It is classified as an investigational immunomodulatory agent.

Investigated diseases

  • Advanced unresectable cutaneous melanoma

    A type of skin cancer that begins in pigment‑producing cells and has spread beyond the initial skin layer, so surgery cannot remove it. The disease usually grows deeper into the skin, invades nearby lymph nodes, and may spread to distant organs, increasing in size and number over time.

  • Solid tumors (non‑melanoma)

    Abnormal masses of cells that develop in organs or tissues other than the skin and are not blood‑cell cancers. These tumors often start as small growths, gradually enlarge, can invade surrounding structures, and may spread to other body parts as they progress.

Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase I/IITrial ID2026-527193-36-00Protocol codeJJP-1008-01-01Estimated enrolment30 patientsSponsorJJP BIOLOGICS Sp. z o.o.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

Tell us about your condition – we search every trial in Europe and connect you with the right site.