A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors

Part of paid clinical trials in New York, New York.

Sponsor
Johnson & Johnson Enterprise Innovation Inc.
Study ID
NCT06311578
Phase
PHASE1
Status
Recruiting
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Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JNJ-87704916 — DRUG
    JNJ-87704916 will be administered as an intratumoral injection.
  • Cetrelimab — DRUG
    Cetrelimab will be administered.
  • Standard of Care PD(L)-1 — DRUG
    Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.

Study Details

The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.

Key Dates

Start date
Apr 10, 2024
Status verified
Jun 2026
Primary completion
Nov 8, 2028
Completion
Aug 26, 2032

Study Design

Enrollment
126 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation
    Participants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested.
  • Experimental: Part 2: Dose Expansion
    Part 2 will consist of three cohorts: Cohort A, B and C. Participants in cohort A\&B with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Cohort C will evaluate JNJ-87704916 treatment in combination with ongoing Standard of care (SoC) PD(L)-1 antibody therapy in frontline treatment of NSCLC.

Primary Outcome Measure

Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
UPMC Cancer CentersPittsburghPennsylvania15232-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in New York, NY

By research site
NYU Langone Health· New York, NYFox Chase Cancer Center· Philadelphia, PAUPMC Cancer Centers· Pittsburgh, PAMD Anderson Cancer Center· Houston, TX

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