Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation

This is a multicenter, open-label phase 1/2a study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of JAB-21822 in combination with JAB-3312 in patients with advanced solid tumors harboring KRAS p.G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion phase, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.

Trial Details

NCT ID
NCT05288205
Phase
PHASE1 / PHASE2
Sponsor
Allist Pharmaceuticals, Inc.
Status
RECRUITING
Cancer Type
Adenocarcinoma Lung Cancer
Interventions
  • JAB-21822
  • JAB-3312
Locations (sample)
  • Hefei, Anhui, China|31.86389,117.28083
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed;
  • Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors harboring KRAS p.G12C mutation who hav…
  • Expected survival ≥ 3 months;
  • Subjects must have at least one measurable lesion as defined by RECIST v1.1. If no measurable lesion untreated with radiation is selected as the ta…

For full eligibility, visit ClinicalTrials.gov.

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