Clinical trial · Interventional
A Phase 1/2 Study of GEN1286 in Patients With Advanced Solid Tumors
NCT06685068CI-TRIAL-00117800terminatedPhase 1 / Phase 2ClinicalTrials.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): Genmab has decided to terminate the GEN1286 program due to an unfavorable benefit-risk profile not supporting further development.
Summary
Brief summary (as posted)
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity and immunogenic potential of GEN1286 in participants with advanced solid tumors. This trial consists of 2 parts: * Part A: Dose escalation and dose level expansion * Part B: Tumor-specific expansion with dose optimization
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 Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GEN1286 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GEN1286
- interventionNames
- Drug: GEN1286
Primary outcomes (2)
- measure
- Number of Participants With Adverse Events (AEs)
- timeFrame
- From first dose until 12 months post last dose of study drug or withdrawal of consent, death, or study closure, whichever occurs first (Up to approximately 3 years 9 months)
- measure
- Number of Participants With Dose Limiting Toxicities (DLTs)
- timeFrame
- During first cycle (Cycle length=21 days)
- description
- Toxicities will be graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Participants must be ≥ 18 years of age at the time of informed consent; have measurable disease according to RECIST 1.1; Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; adequate organ, bone marrow, liver, coagulation, and renal function; and be willing to provide a pretreatment tumor specimen. * All participants must have pathologically confirmed diagnosis of advanced solid tumor. * Participants must have metastatic or unresectable locally advanced, recurrent disease not amenable to further local therapy and must have previously received therapies known to confer clinical benefit (unless ineligible to receive, refused to receive, or therapy is unavailable in the region). Key Exclusion Criteria: \- Prior treatment with topoisomerase 1-based antibody-drug conjugate (ADC) therapy. Note: Other protocol-defined inclusion and exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.