A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancers

Phase 1

• Conditions: Advanced Stage Solid Tumors; MedDRA version: 21.0Level: LLTClassification code: 10049280Term: Solid tumour Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-506144-16-00
• Lead Sponsor: Janssen - Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-07
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Parts 1-4: Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1, 2. Parts 1-4: Has thyroid function laboratory values within normal range, 3. Parts 1-4: Females of childbearing potential must have a negative serum pregnancy test, 4.Parts 1-4: Willing and able to adhere to the prohibitions and restrictions specified in this protocol, 5. Participant must have evaluable disease. For Part 2 only: Participants enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy, 6. Parts 1 to 4: Have evaluable disease

Exclusion Criteria

1. Has uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure (New York Heart Association class III-IV), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements, 2. Has had prior treatment with an anti-Programmed-cell death receptor-1 (PD-1) antibody, anti-the ligand to programmed-cell death 1 (PD-L1) antibody or anti-the ligand to programmed-cell death 2 (PD-L2) antibody, 3. Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 half lives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration, 4. Grade 3 or higher toxicity effects from previous treatment with immunotherapy, 5. A female who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified