Clinical trial · Interventional
A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors
A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors
NCT04397276CI-TRIAL-00103426completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JNJ-70218902 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Escalation
- description
- Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-70218902. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
- interventionNames
- Drug: JNJ-70218902
- type
- EXPERIMENTAL
- label
- Part 2: Dose Expansion
- description
- Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1.
- interventionNames
- Drug: JNJ-70218902
Primary outcomes (3)
- measure
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed * Measurable or evaluable disease * Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy * If the participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (GnRH), this therapy must have been initiated prior to first dose of study drug and must be continued throughout the study * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 * Adequate organs functions Exclusion Criteria: * Known brain metastases * Concurrent use of any other anticancer treatment or investigational agent for the treatment of advanced disease * Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (\<=) 1 or baseline, except for alopecia and vitiligo * Solid organ or bone marrow transplantation * Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients * Certain comorbidities
References
Publications (0)
Data not yet available
No reference posted for this study.