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Clinical Trials in China / NCT05276726
Recruiting Phase 1/2

A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1

NCT05276726 · tracked via the Priya Life Science China tracker
Sponsor
Allist Pharmaceuticals, Inc
Phase
Phase 1/2
Started
2022-08-17
Last updated
2026-08-13

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

JAB 21822 →

JAB 21822: Administered orally

Study summary

Evaluate the safety and tolerability, drug levels, and clinical activity of JAB-21822 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors with KRAS p.G12C mutation and a serine/threonine kinase 11 (STK11) co-mutation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing. 2. STK11 co-mutation and KEAP1 Wild-Type (local confirmation) 3. Treatment naïve or have received at least 1 prior standard therapy for advanced NSCLC 4. ECOG 0-1 Exclusion Criteria: 1. Has CNS metastases or carcinomatous meningitis, except treated CNS metastases with no evidence of radiographic progression or hemorrhage for at least 28 days 2. Any severe and/or uncontrolled medical conditions 3. Active infection requiring systemic treatment within 7 days 4. Therapeutic radiation therapy within 3 weeks of study day 1

Primary outcome measure(s)

  • Dose Escalation phase Number of participants with dose limiting toxicities (DLTs) — At the end of Cycle 1 (each cycle is 21 days)
    A DLT is defined as the clinically significant treatment-related adverse event or abnormal laboratory values assessment during the first 21 days of Cycle 1. It excludes adverse events (AEs) that are deemed clearly related to underlying disease, progression, or intercurrent illness.
  • Dose Escalation phase: Number of participants with adverse events — Up to 3 years
    Patients will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
  • Dose Expansion phase: Objective response rate (ORR) — Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.
    ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1

Trial sites (21)

FacilityCityRegionStatus
Research site08 Beijing Beijing Municipality Not Yet Recruiting
Research site09 Beijing Beijing Municipality Not Yet Recruiting
Research site021 Beijing Beijing Municipality Not Yet Recruiting
Research site02 Beijing Beijing Municipality Not Yet Recruiting
Research site01 Beijing Beijing Municipality Recruiting
Research site013 Beijing Beijing Municipality Not Yet Recruiting
Research site010 Chongqing Chongqing Municipality Not Yet Recruiting
Research site05 Xiamen Fujian Not Yet Recruiting
Research site011 Shenzhen Guangdong Not Yet Recruiting
Research site016 Nanning Guangxi Not Yet Recruiting
Research site017 Shijiazhuang Hebei Not Yet Recruiting
Research site018 Harbin Heilongjiang Not Yet Recruiting
Research site04 Zhengzhou Henan Not Yet Recruiting
Research site012 Changsha Hunan Not Yet Recruiting
Research site015 Changchun Jilin Not Yet Recruiting
Research site06 Shenyang Liaoning Not Yet Recruiting
Research site07 Shenyang Liaoning Not Yet Recruiting
Research site014 Hohhot Neimenggu Not Yet Recruiting
Research site020 Xi’an Shanxi Not Yet Recruiting
Research site03 Hubei Wuhan Not Yet Recruiting
Research site019 Hangzhou Zhejiang Not Yet Recruiting

More Allist Pharmaceuticals, Inc. trials in China

Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation Recruiting
JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation Active, not recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Recruiting
A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation. Recruiting
A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy（FIRMOST） Recruiting

Other trials for the same condition

Efficacy and Safety of SKB264 Plus Anlotinib in EGFR-TKI-Resistant Advanced NSCLC With Liver Metastasis Starting soon
A Phase II Study of HS-20093 Injection Combined With Adebrelimab Versus HS-20093 Injection in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations Recruiting
A Phase III Study to Assess the Effects of Almonertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer Recruiting
68Ga-grazytracer PET/CT for Early Assessment of Response to Neoadjuvant Immunotherapy in Resectable NSCLC Recruiting
Pulsed Field Ablation for the Treatment of Malignant Lung Tumors Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05276726 on ClinicalTrials.gov ↗ ← All trials in China