A Phase 1, First-in-human, Open-label, Multicenter Study of JZP898 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors

JZP898-101

This Phase 1 first-in-human study will investigate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of JZP898 monotherapy as well as JZP898 in combination with pembrolizumab in adult participants with advanced or metastatic solid tumors.

2023-11-07

2027-11-30

2028-05-31

Recruiting

Early phase I

177

Inclusion Criteria * Adult ≥ 18 years of age * Histological or cytological diagnosis of advanced or metastatic solid tumor. a. Previously treated participants with solid tumors (NSCLC, melanoma, HNSCC, RCC, HCC, gastroesophageal carcinomas, UC, or CRC \[MSI-H\]) for whom, in the opinion of the investigator, there is no SoC available to convey clinical benefit. * Participants in select tumor types: 1. NSCLC: eligible for platinum-based therapy and received platinum-based therapy prior to inclusion in the study. 2. HNSCC: eligible for platinum therapy and received platinum-based therapy prior to inclusion in this study. 3. Melanoma with known BRAFv600 mutation: received BRAF/MEKi therapy before this study. * ECOG score of 0 to 1. * Measurable disease per RECIST v1.1 criteria. * Parts A1 and A2 only: willing to consent to mandatory tumor biopsies (both pretreatment and post-treatment with JZP898) unless medically infeasible * Adequate organ and bone marrow function as indicated by the following laboratory values (within 4 weeks prior to starting the study interventions) * Men and women of reproductive potential to observe highly effective birth control for the duration of treatment and for 4 months following the last dose of study drug; * Additional criteria may apply Exclusion Criteria * Unresolved toxicities \> Grade 1. * Hypersensitivity to mAb, IFNα, or study intervention components. * Primary CNS tumor or symptomatic CNS metastases. * Have a second primary malignancy treated within the previous 2 years (exceptions: non-metastatic, non-melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ). * Active autoimmune disease (in the last 2 years) requiring systemic steroids or immunosuppressive agents. * Active or history of pneumonitis or interstitial lung disease requiring steroid treatment. * Any history of suicidal behavior or any suicidal ideation * Clinically significant ischemic/hemorrhagic cerebrovascular accident/stroke and/or clinically significant active cardiovascular disease * Received any anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug * Received prior radiotherapy within 2 weeks of the first dose of study drug * Major surgery within 2 weeks prior to the first dose of study intervention. * Participant is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study * Had an allogeneic tissue/solid organ transplant. * Receipt of prior IFNα therapy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 177, 'type': 'ESTIMATED'}}

2024-04-19