Clinical trial · Interventional
A Study of Safety, Pharmacokinetics, Pharmacodynamics of JNJ-61610588 in Participants With Advanced Cancer
An Open-label, First-in-Human, Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-61610588, a Fully Human IgG1 Kappa Anti-VISTA (V-domain Ig Suppressor of T-cell Activation) Monoclonal Antibody, in Subjects With Advanced Cancer
NCT02671955CI-TRIAL-00032255terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Janssen business decision
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and tolerability of JNJ-61610588 in participants with advanced cancer in order to determine a recommended Phase 2 dose (RP2D) for further evaluation in specific tumor types.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JNJ-61610588 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Escalation
- description
- Participants with advanced solid tumors will receive intravenous infusions of JNJ-61610588 until disease progression. Dose escalation will continue until the maximum tolerated dose is reached.
- interventionNames
- Drug: JNJ-61610588
- type
- EXPERIMENTAL
- label
- Part 2: Biomarker Evaluation
- description
- Participants with metastatic Non-small Cell Lung Cancer (NSCLC) will receive intravenous infusion of JNJ-61610588 at or below the recommended Phase 2 dose (RP2D) until disease progression.
- interventionNames
- Drug: JNJ-61610588
- type
- EXPERIMENTAL
- label
- Part 3: Dose Expansion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The participant has a solid tumor. Parts 2 and 3 are limited to participants with non-small cell lung cancer. Part 4 is limited to participants with small cell lung, head and neck, pancreatic, colorectal, and cervical cancers * Tumor progression following at least one prior standard therapy * The participant has a radiographically measurable tumor. Evaluable disease is acceptable for Part 1 only * The participant is willing to consent to provide a tumor tissue sample (fresh biopsy) before (Parts 2 and 3) and after (Part 2 only) receiving the study drug * The participant is able to carry out daily life activities without difficulty * The participant does not have significant side effects from previous anti-cancer treatment * The participant has adequate organ and blood cell counts * Sexually active participants must use medically acceptable methods of contraception during the course of this study Exclusion Criteria: * The participant has a history of major surgery or treatment other cancer therapy within 2-6 weeks before starting the study * The participant has an untreated brain tumor * Current severe, uncontrolled systemic disease including an ongoing, active infection requiring treatment with antibiotics * The participant has high blood pressure or diabetes that is not well-controlled with medication * History of clinically significant heart problems * History of severe side effects toimmunotherapy * The participant is pregnant, breastfeeding, or planning to become pregnant or father a child * Positive for Hepatitis B, Hepatitis C, or HIV * The participant has received anticoagulant therapy with the exception of aspirin within 1 week of starting the study
References
Publications (0)
Data not yet available
No reference posted for this study.