Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated NSCLC

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT07339839
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • KRAS G12C
  • NSCLC Stage IV

Eligibility Criteria

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

Interventions

  • Glecirasib — DRUG
    For Phase I Dose Escalation, Glecirasib includes 2 dose cohorts: 600 mg QD and 800 mg QD, respectively, to determine the Glecirasib PR2D dose for the Phase II study.
  • Ivonescimab — DRUG
    Administered intravenously at 20 mg/kg, every 3 weeks (Q3W).

Study Details

This study evaluates the safety, tolerability, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase II dose (RP2D) of Glecirasib in combination with Ivonescimab in patients with previously untreated, KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥1%. The study includes a Phase I 3+3 dose-escalation stage followed by a Phase II Simon two-stage design to assess preliminary antitumor efficacy.

Key Dates

Start date
Mar 1, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Glecirasib Combined With Ivonescimab

Primary Outcome Measure

Phase I: Maximum Tolerated Dose (MTD) [ Time Frame: 21 days after the first dose. ]

Central Contacts

Related Studies