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NCT Number: NCT05009329

A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China

To assess safety, tolerability, PK, efficacy and determine recommended phase 2 dose (RP2D) of JAB-21822 (glecirasib) administered in adult participants with KRAS p.G12C-mutant advanced solid tumors.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

NSCLC Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Solid Tumor Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent
  • Advanced (metastatic or unresectable) KRAS p.G12C mutant solid tumors, with failure or absence of standard treatment
  • Subject must be ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Subjects with life expectancy ≥3 months.
  • Subjects must have at least one measurable lesion as defined by RECIST v1.1.
  • There was no serious organ dysfunction in the screening stage
  • Male or female subjects of reproductive age agree to use adequate contraception

Exclusion criteria

  • History of intestinal disease or major gastric surgery or inability to swallow oral medications
  • Other active cancer
  • Previously treated with KRAS G12C inhibitor
  • Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
  • Impaired heart function or clinically significant heart disease
  • Pregnant or breast-feeding
  • Previous allogeneic bone marrow transplant or organ transplant
  • Intended study subjects who were unable to abstain from alcohol during medication
  • Other unqualified conditions judged by the investigators

Treatment and study plan

JAB-21822

Drug

JAB-21822 will be administered orally

Other names: glecirasib

Primary outcomes

  1. Incidence of dose limiting toxicities (DLTs) in the dose escalation phase

    Time frame: first 21 days

    Number of participants with dose limiting toxicities

  2. 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

  3. Overall response rate (ORR) by IRC (independent review committee)

    Time frame: up to 3 years

    ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1

Secondary outcomes

  1. Overall response rate (ORR) by investigator

    Time frame: up to 3 years

    ORR is defined as the proportion of participants with complete response and partial response (CR+PR) per RECIST v 1.1

  2. 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 study drug therapy, to disease progression or death due to any cause, whichever occurs first.

  3. Disease Control Rate ( DCR )

    Time frame: up to 3 years

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

  4. 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 or death per RECIST v1.1, which occurs first

  5. Time to response (TTR)

    Time frame: up to 3 years

    Time from patient randomization (first treatment) to first response per RECIST 1.1 criteria

  6. Peak Plasma Concentration (Cmax)

    Time frame: up to 3 years

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

Sponsors and collaborators

Lead sponsor

Allist Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Multi-center, Open, Dose-escalation, and Expanded Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JAB-21822 in Advanced Solid Tumors With KRAS p.G12C Mutation

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2021
Registry last updated
Mar 13, 2026

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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