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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Mar 2026 → Mar 2027
See other at-risk trials from Allist Pharmaceuticals, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Mar 2026 to Mar 2027v6
  2. Study Identification, Study Status, Contacts/Locationsv5
  3. Lead sponsor: Jacobio Pharmaceuticals Co., Ltd. to Allist Pharmaceuticals, Inc.
    • Enrollment target: 124 to 240
    • Study sites: 24 to 27
    • Eligibility criteria shortened, about 6 words
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 72 to 124
    • Study sites: 1 to 24
    • Start date changed from estimate of Mar 2022 to Apr 14, 2022
    v3
  5. Eligibility criteria expanded, about 7 words
    • Study arms: 1 to 2
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT05288205
Lead Sponsor Allist Pharmaceuticals, Inc.
Conditions
(from sponsor)		 KRAS P.G12C, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Carcinoma
Related terms Carcinoma, Non-Small-Cell Lung, Carcinoma, Pancreatic Ductal, Colorectal Neoplasms
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov