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
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adagrasib — DRUG
    Given by mouth
  • Iza-bren — DRUG
    Given 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

First listed
Feb 3, 2026
Start date
May 15, 2026
Status verified
Aug 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) Q3W
    Adagrasib 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

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Marcelo V Negrao, MD
[email protected]
713-745-7943
Marcelo V Negrao, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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