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

Allist Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: JAB 21822

Study type: Interventional

Funder types: Industry

Identifiers

NCT05276726

JAB-21822-1003

Details and patient eligibility

About

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.

Full description

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 during Dose Escalation phase and preliminary antitumor activity in patients with NSCLC with concurrent KRAS G12C mutant and STK11 mutant and KEAP wild type either treatment naïve or at least one line prior therapy for advance disease during the expansion phase..

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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104 participants in 3 patient groups

Phase 1 ,Dose Exploration ,monotherapy

Experimental group

Description:

Dose escalation of JAB21822 will be administered as monotherapy to determine the MTD and RP2D

Treatment:

Drug: JAB 21822

Phase 2, Dose Expansion, Part1 monotherapy

Experimental group

Description:

Part 1 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects with previously untreated advanced non-small cell lung cancer (NSCLC)

Treatment:

Drug: JAB 21822

Phase 2 Dose Expansion, Part 2 monotherapy

Experimental group

Description:

Part 2 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects who had received at least one previous line of systemic therapy for NSCLC

Treatment:

Drug: JAB 21822