Testing JJP-1008 alone or with another drug in advanced melanoma and other solid tumors

Trial details

Who runs it

JJP BIOLOGICS Sp. z o.o.

Trial code

EU 2026-527193-36-00

Record updated

8 November 2026

Original description

1. Part A: To determine the MTD and/or RP2D of JJP‑1008 as monotherapy 2. Part A: To evaluate the safety and tolerability of JJP-1008 as monotherapy 3. Part B and Part C: To evaluate the safety and tolerability of JJP-1008 as monotherapy (Part B) or in combination with an ICI (Part C). 4. Part B and Part C: To confirm the MTD and/or RP2D of JJP‑1008 when given as monotherapy (Part B) or in combination with an ICI (Part C). 5. Part B and Part C: To evaluate the preliminary efficacy per RECIST v1.1 and/or iRECIST of JJP‑1008 as monotherapy (Part B) or in combination with an ICI (Part C).Read full original descriptionShow less

A Phase I/II, Multi-part, Open-label, Multicenter, First-in-human Trial to Evaluate Safety, Tolerability, Immunogenicity, and Signals of Efficacy of JJP-1008 as Monotherapy and in Combination in Participants with Advanced, Unresectable Skin Melanoma and Other Solid Tumors

1. Part A: To determine the MTD and/or RP2D of JJP‑1008 as monotherapy 2. Part A: To evaluate the safety and tolerability of JJP-1008 as monotherapy 3. Part B and Part C: To evaluate the safety and tolerability of JJP-1008 as monotherapy (Part B) or in combination with an ICI (Part C). 4. Part B and Part C: To confirm the MTD and/or RP2D of JJP‑1008 when given as monotherapy (Part B) or in combination with an ICI (Part C). 5. Part B and Part C: To evaluate the preliminary efficacy per RECIST v1.1 and/or iRECIST of JJP‑1008 as monotherapy (Part B) or in combination with an ICI (Part C).

Inclusion: Patient has voluntarily agreed to participate by giving written informed consent; Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1; Adequate hematologic function as defined in Protocol Inclusion Criteria section; Adequate hepatic function as defined in Protocol Inclusion Criteria section; Adequate renal function defined in in Protocol Inclusion Criteria section; Women of child-bearing potential (WOCBP) must agree to use highly effective methods of contraception for the duration of the trial and until the end of relevant systemic exposure to JJP-1008, as determined based on emerging clinical pharmacokinetic data. Male patients with partners of child-bearing potential must agree to use double barrier method of birth control for the duration of the trial and until the end of relevant systemic exposure to JJP-1008, and their WOCBP partners must use a highly effective method of contraception during the same period or have a history of a vasectomy. A history of successful vasectomy may fulfil the applicable contraception requirement, as specified in Section 5.4.2. Patients must agree not to donate sperm or oocytes for reproductive purposes during treatment with JJP-1008 and until the end of relevant systemic exposure to JJP-1008. Refer to Section 5.4.1 for definitions of WOCBP, postmenopausal status, and non-childbearing potential. Refer to Section 5.4.2 for highly effective contraceptive methods; Willing and able to provide written informed consent and able to comply with all trial procedures; Patient has an estimated life expectancy as defined in the Clinical Study Protocol; Male or female patient aged ≥18 years; Body mass index <40 kg/m2; Part A: Patient must have a histological or cytological diagnosis of melanoma, RCC, HCC, NSCLC, SCLC, GC, esophagus carcinoma, gastric-esophageal junction carcinoma, breast cancer, MSS CRC, bladder cancer, prostate cancer. The patient must have progressive metastatic disease, or progressive locally advanced disease not amenable or refractory to SoC; Part B and C: Patient must have a histological or cytological diagnosis of melanoma, colon, gastric, lung or other solid tumors previously evaluated in Part A with progressive locally advanced (Stage III) or metastatic (stage IV) disease that is not amenable to definitive local therapy with curative intent and not eligible or refractory to SoC systemic therapy; Patient has experienced progression of locally advanced or metastatic disease and has exhausted appropriate available standard-of-care systemic treatment options expected to provide clinical benefit, unless such treatment is contraindicated, not tolerated, or otherwise medically inappropriate for the individual patient. For patients with BRAF-mutated melanoma who remain eligible for BRAF/MEK inhibitor therapy following progression on SoC ICI therapy, enrolment without prior BRAF/MEK inhibitor treatment may be permitted only if such treatment is contraindicated, not tolerated, or otherwise considered medically inappropriate based on the individual patient's clinical circumstances. The rationale for not administering BRAF/MEK inhibitor therapy must be documented by the Investigator; Newly obtained biopsies are required for patient with melanoma and optional for other tumor types depending on feasibility of obtaining tissue. The pre-treatment biopsy can include available historical biopsy if the sample was collected within 60 days prior to trial intervention administration and was collected after prior treatment was stopped and the relevant wash-out period completed; (1) Measurable disease (mandatory for Part B and C) defined as: at least 1 lesion, as defined in the Clinical Study Protocol, that is serially measurable according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and/or immune-modified Response Evaluation Criteria in Solid Tumors (iRECIST) using computed tomography (CT)/magnetic resonance imaging (MRI) and will not be used for on-trial paired biopsies. (2)Measurable disease (mandatory for Part B and C) defined as: Lesions that have had external beam radiotherapy or loco-regional therapies such as radiofrequency ablation must show subsequent evidence of substantial size increase to be deemed a target lesion. (3)For Part A, patient may have non-measurable but radiologically evaluable according to RECIST v1.1 and/or iRECIST disease.

Exclusion: Clinically significant cardiovascular disease, e.g., cerebral vascular accident/stroke or myocardial infarction, within 6 months prior to trial intervention administration, unstable angina, congestive heart failure (New York Heart Association Class ≥III), or unstable cardiac arrhythmia requiring medication; History of a major bleeding event (requiring a blood transfusion of >2 units) not related to a tumor within 12 months prior to trial intervention administration; Hepatitis C antibody positive with hepatitis C virus (HCV) viral load ≥LLOQ. Seropositivity for antibodies to HCV at Screening does not preclude participation in the trial, provided that two negative HCV ribonucleic acid (RNA) test results obtained at least 6 months apart after completion of antiviral treatment and prior to Screening are documented, and a third negative HCV RNA test result is confirmed at Screening; Ongoing CTCAE Grade ≥2 toxicity related to a previously administered anticancer agent with the following exceptions: CTCAE Grade 2 neuropathy or alopecia; CTCAE Grade 2 immune-related endocrinopathy attributed to a checkpoint inhibitor and controlled with hormone replacement alone; (1) Prior treatment with: Any systemic chemotherapy, anticancer small molecule therapy or investigational drug or device within 14 days or 5 half-lives (whichever is longer) prior to trial intervention administration. (2)Prior treatment with: Biological agents (including monoclonal antibodies) within 28 days or 5 elimination half-lives of the respective agent (whichever is longer) prior to trial intervention administration. (3)Prior treatment with: Radiation, within 14 days prior to trial intervention administration or without adequate recovery from clinically relevant radiation-related toxicity prior to trial intervention administration. (4)Prior treatment with: Treatment with nitrosoureas or mitomycin C requires a 42-day washout prior to trial intervention administration; Has received any prior immunotherapy and was discontinued from that treatment due to a severe or worse immune-related adverse event (irAE); Has received a live vaccine within 30 days prior to trial intervention administration; Major surgery or significant traumatic injury within 4 weeks prior to trial intervention administration. If major surgery has occurred >28 days prior to trial intervention administration, the patient must have recovered adequately from the toxicity and/or complications from the intervention prior to their first dose of trial drug; Excluding the primary tumor leading to enrollment in this trial, any other active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the bladder or cervix) within 24 months prior to trial intervention administration; Untreated primary CNS malignancy. Patients with stable (≥4 weeks) CNS metastases post radiotherapy and no longer receiving corticosteroids prior to trial intervention administration, may be considered for this trial; Use of immunosuppressive medications within 4 weeks or systemic corticosteroids at doses exceeding 10 mg/ day (prednisone equivalent) within 2 weeks prior to trial intervention administration. Physiologic, replacement doses of hydrocortisone, or its equivalent, are acceptable. This is up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg of prednisone) in the evening; Active autoimmune disease that has required systemic treatment within 2 years prior to trial intervention administration; Active infection requiring IV antibacterial, antiviral, or antifungal therapy within 2 weeks prior to trial intervention administration; History of severe hypersensitivity reactions to other monoclonal antibodies; Hepatitis B surface antigen (HBsAg) positivity or anti-hepatitis B core (anti-HBc) positivity with detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) above the lower limit of quantification (LLOQ). HBsAg-positive individuals with documented absence of active HBV infection, as evidenced by negative HBV DNA, may be enrolled provided liver function is adequate and appropriate monitoring is implemented; Known allergy/intolerance to JJP-1008 excipients; Intercurrent illness that is either life-threatening or of clinical significance such that it might limit compliance with trial requirements, or in the Investigator's assessment would place the patient at an unacceptable risk for participation; History of splenectomy; Parts C only: Known allergy/intolerance to the ICI or its excipients; History of idiopathic pulmonary fibrosis, organizing pneumonia, drug‑induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan; History of an allogenic tissue/solid organ transplant; History of clinically significant coagulation or platelet disorder or a history of being refractory to platelet transfusions within 12 months prior to trial intervention administration; Human immunodeficiency virus (HIV) infection with an acquired immune deficiency syndrome-defining opportunistic infection within 12 months prior to trial intervention administration or with a CD4+ T cell count <350/µL; Pregnant or breastfeeding female; Ocular melanoma or any type of melanoma other than cutaneous.

EU CTIS 2026-527193-36-00