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

Phase 2RecruitingNCT05276726

Allist Pharmaceuticals, Inc.104 enrolled

Overview

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.

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..

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Non-small Cell Lung Cancer

Interventions

JAB 21822DRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Research site08

Beijing, Beijing Municipality, China

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)

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.

Time frame: At the end of Cycle 1 (each cycle is 21 days)

Dose Escalation phase: Number of participants with adverse events

Patients will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria

Time frame: Up to 3 years

Dose Expansion phase: Objective response rate (ORR)

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1

Time frame: Up to 3 years - from baseline to confirmed Progressive Disease per RECIST.

Secondary Outcomes

Dose Escalation phase: Objective response rate (ORR)

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1

Time frame: Up to 3 years - from baseline to RECIST confirmed Progressive Disease

Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)

PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per RECIST1.1 or death whichever occurs first

Time frame: Up to 3 years

Dose Escalation and Dose Expansion phase: Duration of response (DOR)

DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.

Central Contacts

Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd

CONTACT

021-80423288 zhenhua.gong@allist.com.cn

Wang Jie Wang Jie M.D.

CONTACT

010-87788029 zlhuxi@163.com

Data from ClinicalTrials.gov

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