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NCT Number: NCT05194995

JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation

This study is to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of JAB-21822 in combination with cetuximab in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Colorectal Cancer Appendiceal Cancer Appendiceal Neoplasms Cecal Diseases Cecal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Small Intestinal Cancer

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 in combination with cetuximab to determine the MTD and RP2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 is administered in combination with cetuximab during Dose Expansion phase in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.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 advanced colorectal cancer, advanced small intestinal cancer and advanced appendiceal cancer with KRAS p.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 metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days
  • Active infection requiring systemic treatment within 14 days
  • Active HIV, HBV or HCV
  • Any severe and/or uncontrolled medical conditions
  • LVEF<50% assessed by ECHO
  • QT interval >470 msec

Treatment and study plan

JAB-21822

Drug

JAB-21822 administered orally as a tablet.

Cetuximab

Drug

Cetuximab administered as an intravenous (IV) infusion.

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 (TRAE) or abnormal laboratory values assessment during the first 21 days of (Cycle 1) and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.

  2. 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.

Secondary outcomes

  1. 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.

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

    Time frame: Up to 4 years

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

  3. 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 will be measured by using plasma PK samples.

  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.

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

    Time frame: Up to 4 years

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

  6. 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.

  7. 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

Allist Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase Ib/II Trial of JAB-21822 in Combination With Cetuximab in Patients With Advanced Colorectal Cancer, Small Intestine Cancer and Appendiceal Cancer With KRAS G12C Mutation

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 18, 2022
Registry last updated
Mar 16, 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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