NCT05009329

Multi-center, Open, Dose-escalation, and Expanded Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JAB-21822 in Advanced Solid Tumors With KRAS p.G12C Mutation

Active, enrolled Phase 1/Phase 2 Last updated 12 March 2026

What this trial tests

Phase 1/Phase 2 trial testing JAB-21822 in NSCLC in 315 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 July 2021

Primary endpoint
1 May 2026

1 December 2026

Quick facts

Lead sponsor	Allist Pharmaceuticals, Inc.
Phase	Phase 1/Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	315
Start date	26 July 2021
Primary completion	1 May 2026
Estimated completion	1 December 2026
Sites	1 location across China

Drugs / interventions tested

• JAB-21822 — full drug profile →
• JAB-21822 — full drug profile →
• JAB-21822 — full drug profile →

Conditions studied

• NSCLC — all drugs for NSCLC →
• Solid Tumor — all drugs for Solid Tumor →

Sponsor

Allist Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with NSCLC or Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of dose limiting toxicities (DLTs) in the dose escalation phase
  Time frame: first 21 days
  Number of participants with dose limiting toxicities
• Number of participants with adverse events
  Time frame: up to 3 years
  Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria
• Overall response rate (ORR) by IRC (independent review committee)
  Time frame: up to 3 years
  ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1

Sponsor's own description

To assess safety, tolerability, PK, efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 (glecirasib) administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The current state of the art and future trends in RAS-targeted cancer therapies.
   Punekar SR, Velcheti V, Neel BG, Wong KK. · · 2022 · cited 382× · PMID 36028717 · DOI 10.1038/s41571-022-00671-9
2. Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
   Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
3. Progress on Ras/MAPK Signaling Research and Targeting in Blood and Solid Cancers.
   Dillon M, Lopez A, Lin E, Sales D, et al · · 2021 · cited 99× · PMID 34680208 · DOI 10.3390/cancers13205059
4. Consensus, debate, and prospective on pancreatic cancer treatments.
   Wang J, Yang J, Narang A, He J, et al · · 2024 · cited 56× · PMID 39390609 · DOI 10.1186/s13045-024-01613-x
5. Targeting small GTPases: emerging grasps on previously untamable targets, pioneered by KRAS.
   Yin G, Huang J, Petela J, Jiang H, et al · · 2023 · cited 50× · PMID 37221195 · DOI 10.1038/s41392-023-01441-4
6. KRAS Mutations in Solid Tumors: Characteristics, Current Therapeutic Strategy, and Potential Treatment Exploration.
   Yang Y, Zhang H, Huang S, Chu Q. · · 2023 · cited 50× · PMID 36675641 · DOI 10.3390/jcm12020709
7. Unravelling the Complexity of Colorectal Cancer: Heterogeneity, Clonal Evolution, and Clinical Implications.
   Saoudi González N, Salvà F, Ros J, Baraibar I, et al · · 2023 · cited 46× · PMID 37627048 · DOI 10.3390/cancers15164020
8. MYC and KRAS cooperation: from historical challenges to therapeutic opportunities in cancer.
   Casacuberta-Serra S, González-Larreategui Í, Capitán-Leo D, Soucek L. · · 2024 · cited 43× · PMID 39164274 · DOI 10.1038/s41392-024-01907-z