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NCT Number: NCT05276726

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research site01, Beijing, Beijing Municipality, China

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About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing.
  • STK11 co-mutation and KEAP1 Wild-Type (local confirmation)
  • Treatment naïve or have received at least 1 prior standard therapy for advanced NSCLC
  • ECOG 0-1

Exclusion criteria

  • Has CNS metastases or carcinomatous meningitis, except treated CNS metastases with no evidence of radiographic progression or hemorrhage for at least 28 days
  • Any severe and/or uncontrolled medical conditions
  • Active infection requiring systemic treatment within 7 days
  • Therapeutic radiation therapy within 3 weeks of study day 1

Treatment and study plan

JAB 21822

Drug

Administered orally

Primary outcomes

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

    Time frame: 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.

  2. Dose Escalation phase: Number of participants with adverse events

    Time frame: Up to 3 years

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

  3. Dose Expansion phase: Objective response rate (ORR)

    Time frame: 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

Secondary outcomes

  1. Dose Escalation phase: Objective response rate (ORR)

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

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

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

    Time frame: Up to 3 years

    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

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

    Time frame: Up to 3 years

    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.

  4. Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)

    Time frame: Up to 3 years

    DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1

  5. Dose Escalation and Dose Expansion phase: Overall Survival (OS)

    Time frame: Up to 3 years

    Defined as time from first treatment to death by any cause

  6. Dose Escalation and Dose Expansion phase: Time to response (TTR)

    Time frame: Up to 3 years

    Defined as time from first treatment to first evidence of PR or CR

  7. Dose Expansion phase: 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

  8. Dose Escalation and Dose Expansion phase: Plasma concentration (Cmax)

    Time frame: Up to 3 Years

    Cmax of JAB-21822 will be measured by using plasma PK samples

  9. Dose Escalation and Dose Expansion phase: Time to achieve Cmax (Tmax)

    Time frame: Up to 3 Years

    Tmax of JAB-21822 will be measured by using plasma PK samples

  10. Escalation and Dose Expansion phase：Area under the plasma concentration-time curve (AUC)

    Time frame: Up to 3 Years

    AUC of JAB-21822 will be measured by using plasma PK samples

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

021-80423288

Wang Jie Wang Jie M.D.

CONTACT

[email protected]

010-87788029

Sponsors and collaborators

Lead sponsor

Allist Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2022
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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