Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In NSCLC - The IZA-A Trial
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT07382726
- Phase
- PHASE1
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Adagrasib — DRUGGiven by mouth
- Iza-bren — DRUGGiven by IV
Study Details
This research is being done to test a combination of two drugs, Izalontamab Brengitecan (iza-bren) and Adagrasib, in patients with advanced KRAS G12C-mutant NSCLC that hasn't responded to other treatments. The purpose is to see if this combination works better than existing treatments for people whose cancer keeps growing despite KRAS G12C inhibitors.
Key Dates
- Start date
- Jul 1, 2026
- Status verified
- Jan 2026
- Primary completion
- Dec 24, 2027
- Completion
- Dec 24, 2029
Study Design
- Enrollment
- 18 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Combo Treatment with Izalontamab Brengitecan (IV) + Adagrasib (PO) Q3WAdagrasib will be administered at 400mg PO BID continuously. Iza-bren will be administered IV on Day 1 and Day 8 (+3 days) in a 21-day cycle.
Primary Outcome Measure
Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]
Central Contacts
- Marcelo V Negrao, MD713-745-7943
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas M. D. Anderson Cancer Center | Houston | Texas | 77030 | Marcelo V Negrao, MD (PRINCIPAL_INVESTIGATOR) |
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