Evaluating JAB-21822 for advanced lung cancer with specific mutations

A Phase Ib/II ,Single Arm, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of JAB-21822 in Advanced or Metastatic Non-small Cell Lung Cancer With a KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1

This study is testing a new treatment called JAB-21822 to see if it can help people with advanced lung cancer who have certain genetic mutations.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Allist Pharmaceuticals, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 21 sites (Beijing, Beijing Municipality and 20 other locations)
• Trial ID: NCT05276726 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and clinical activity of JAB-21822 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) characterized by KRAS p.G12C and STK11 co-mutations. The trial consists of a Dose Escalation phase to assess safety and a subsequent Expansion phase to evaluate preliminary antitumor activity in treatment-naïve patients or those who have received at least one prior therapy. Participants will undergo molecular testing to confirm their eligibility based on specific genetic mutations.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced or metastatic NSCLC who have KRAS p.G12C and STK11 co-mutations and are either treatment-naïve or have received at least one prior therapy.

Not a fit: Patients with CNS metastases, severe uncontrolled medical conditions, or recent therapeutic radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with a specific genetic profile of lung cancer.

How similar studies have performed: While this approach is focused on a specific mutation profile, similar studies targeting KRAS mutations have shown promising results, indicating potential for success.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing Municipality and 20 other locations

• Research site08 — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Research site09 — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Research site021 — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Research site02 — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Research site01 — Beijing, Beijing Municipality, China (Recruiting)
• Research site013 — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Research site010 — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Research site05 — Xiamen, Fujian, China (Not_yet_recruiting)
• Research site011 — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Research site016 — Nanning, Guangxi, China (Not_yet_recruiting)
• Research site017 — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Research site018 — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Research site04 — Zhengzhou, Henan, China (Not_yet_recruiting)
• Research site012 — Changsha, Hunan, China (Not_yet_recruiting)
• Research site015 — Changchun, Jilin, China (Not_yet_recruiting)
• Research site06 — Shenyang, Liaoning, China (Not_yet_recruiting)
• Research site07 — Shenyang, Liaoning, China (Not_yet_recruiting)
• Research site014 — Hohhot, Neimenggu, China (Not_yet_recruiting)
• Research site020 — Xi’an, Shanxi, China (Not_yet_recruiting)
• Research site03 — Hubei, Wuhan, China (Not_yet_recruiting)
• Research site019 — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd

Conditions Non-small Cell Lung Cancer