Evaluating GEN1286 for advanced solid tumors
A Phase 1/2 Study of GEN1286 in Patients With Advanced Solid Tumors
This study is testing a new treatment called GEN1286 to see if it is safe and effective for people with advanced solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genmab Industry-sponsored |
| Locations | 3 sites (Grand Rapids, Michigan and 2 other locations) |
| Trial ID | NCT06685068 on ClinicalTrials.gov |
What this trial studies
This trial aims to assess the safety, tolerability, pharmacokinetics, anti-tumor activity, and immunogenic potential of GEN1286 in patients with advanced solid tumors. It consists of two parts: the first part focuses on dose escalation and expansion, while the second part involves tumor-specific expansion with dose optimization. Participants must have measurable disease and a confirmed diagnosis of advanced solid tumors, and they will provide a tumor specimen prior to treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that are metastatic or unresectable and have previously received other therapies.
Not a fit: Patients who have previously been treated with topoisomerase 1-based antibody-drug conjugate therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: Other studies involving similar approaches have shown promise, but the specific use of GEN1286 in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Grand Rapids, Michigan and 2 other locations
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- START San Antonio — San Antonio, Texas, United States (Recruiting)
- START Mountain Region — West Valley City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Genmab Trial Information
- Email: clinicaltrials@genmab.com
- Phone: +4570202728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.