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NCT Number: NCT05002270

JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

This study is to evaluate the safety and tolerability of JAB-21822 monotherapy and combination therapy in adult participants with advanced solid tumors harboring KRAS G12C mutation.

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Key information

Conditions

Advanced Solid Tumor Bronchial Neoplasms CRC Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms NSCLC 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

Mayo Clinc, Phoenix, Arizona, United States

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About this study

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 monotherapy to determine the MTD and PR2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 administered alone and combination with cetuximab during Dose Expansion phase in adult participants with advanced solid tumors harboring KRAS G12C mutation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants must be able to provide an archived tumor sample
  • Histologically or cytologically confirmed solid tumors with KRAS G12C mutation
  • Must have received at least 1 prior standard therapy
  • Must have at least 1 measurable lesion per RECIST v1.1
  • Must have adequate organ function
  • Must be able to swallow and retain orally administered medication

Exclusion criteria

  • Has brain or spinal metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days
  • Active infection requiring systemic treatment within 7 days
  • Active HBV or HCV
  • Any severe and/or uncontrolled medical conditions
  • LVEF ≤50% assessed by ECHO or QTcF
  • QT interval >470 msec
  • Experiencing unresolved CTCAE 5.0 Grade >1 toxicities

Treatment and study plan

JAB-21822 (KRAS G12C inhibitor)

Drug

Administered orally

Cetuximab (EGFR inhibitor)

Drug

Administered IV

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)

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

    Time frame: Up to 4 years

    Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria

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

    Time frame: Up to 4 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

  4. Dose Expansion phase: Duration of response ( DOR )

    Time frame: Up to 4 years

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

Secondary outcomes

  1. Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)

    Time frame: Up to 4 years

    Cmax of JAB-21822 alone or JAB-21822 plus cetuximabn will be measured by using plasma PK samples

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

    Time frame: Up to 4 years

    AUC of JAB-21822 alone or JAB-21822 plus cetuximab will be measured by using plasma PK samples

  3. Dose Escalation phase: Overall response rate (ORR)

    Time frame: Up to 4 years - from baseline to RECIST confirmed Progressive Disease

    The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.

  4. Dose Escalation phase: Duration of response ( DOR )

    Time frame: Up to 4 years

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

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

    Time frame: Up to 4 years

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

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

    Time frame: Up to 4 years

    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first

Sponsors and collaborators

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2021
Registry last updated
Jan 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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