Study on the Safety of GEN1046 in Patients with Malignant Solid Tumors
Sponsor: Genmab
ClinicalTrials ID:NCT03917381
This clinical trial is exploring the safety of a new antibody treatment called acasunlimab (GEN1046) for patients with certain types of cancer. The study will test acasunlimab alone and in combination with other cancer treatments to see how well it works.
Patient Parameters
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Program Overview
The trial aims to learn about the effects of acasunlimab, a new antibody treatment, when used alone or with other cancer drugs like docetaxel or pembrolizumab, with or without chemotherapy. All participants will receive the active treatment, and no one will get a placebo. The study has two parts: the first part will determine the safe doses of acasunlimab, and the second part will test these doses on more patients to see how well they work against cancer. Participants can expect to be in the trial for about 74 weeks, with treatment lasting around 21 weeks. Initially, visits will be weekly, then gradually reduce to once every three weeks.
Description
This is an open-label, multi-center study to evaluate the safety of acasunlimab (GEN1046). The trial is divided into two parts: Phase 1, which involves dose escalation to find the safest dose, and Phase 2a, which expands the study to more patients using the recommended dose from Phase 1. The expansion phase will begin once the best dose is determined.
Eligibility Criteria
Inclusion Criteria
- For Dose Escalation: Have a confirmed diagnosis of a non-CNS solid tumor that is metastatic or cannot be surgically removed, with no standard treatment options available.
- For Expansion: Have a confirmed diagnosis of relapsed or refractory advanced/metastatic cancers like NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer, and are not candidates for standard therapy. Specific groups include those with metastatic NSCLC who haven't had systemic treatment for metastatic disease.
- For Both Parts: Have measurable disease, good overall health (ECOG 0-1), and acceptable blood, liver, and kidney function.
Exclusion Criteria
- Have uncontrolled illnesses, such as:
- Active infections needing IV treatment or ongoing inflammatory conditions.
- Severe heart conditions or uncontrolled high blood pressure.
- Autoimmune diseases or history of immune-related side effects from previous treatments.
- History of muscle inflammation, Guillain-Barré syndrome, or myasthenia gravis.
- Chronic liver disease or lung inflammation requiring steroids.
- Recent organ or bone marrow transplants.
- Serious wounds or fractures.
- Have brain conditions like recent or growing brain metastases or stroke.
- Have had recent cancer treatments, such as:
- Radiotherapy within 14 days before starting acasunlimab (except palliative care).
- Anti-cancer drugs within 28 days or less than 5 half-lives before acasunlimab.
- Have unresolved side effects from previous cancer treatments.
Note: Other specific criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic | 85054 | Phoenix | Arizona |
| Yale University Cancer Center | 06520-8028 | New Haven | Connecticut |
| Mayo Clinic | 32224 | Jacksonville | Florida |
| Emory University | 30322 | Atlanta | Georgia |
| University of Iowa Hospitals | 52242 | Iowa City | Iowa |
| Norton Healthcare Inc | 40202 | Louisville | Kentucky |
| University of Michigan | 48109 | Ann Arbor | Michigan |
| START Midwest | 49546 | Grand Rapids | Michigan |
| Mayo Clinic | 55905 | Rochester | Minnesota |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
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