NCT05194995

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
7mo left

Started Feb 2022

Longer than P75 for phase_1

Geographic Reach
1 country

17 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Feb 2022Dec 2026

First Submitted

Initial submission to the registry

December 27, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 17, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

December 27, 2021

Last Update Submit

March 12, 2026

Conditions

Small Intestinal CancerAppendiceal CancerAdvanced Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

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

    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.

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

  • Dose Expansion phase: Overall response rate (ORR)

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

    Up to 4 years - from baseline to RECIST confirmed Progressive Disease

Secondary Outcomes (7)

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

    Up to 4 years

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

    Up to 4 years

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

    Up to 4 years

  • Dose Expansion phase: Duration of response ( DOR )

    Up to 4 years

  • Dose Escalation phase: Overall response rate (ORR)

    Up to 4 years

  • +2 more secondary outcomes

Study Arms (3)

Phase 1b Dose Escalation

EXPERIMENTAL

Dose escalation of JAB-21822 to determine maximum tolerated dose of JAB-21822 in combination with cetuximab.

Drug: JAB-21822Drug: Cetuximab

Phase 2 Dose Expansion, Cohort 1

EXPERIMENTAL

Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.

Drug: JAB-21822Drug: Cetuximab

Phase 2 Dose Expansion, Cohort 2

EXPERIMENTAL

Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced small intestinal cancer and advanced appendiceal cancer.

Drug: JAB-21822Drug: Cetuximab

Interventions

JAB-21822DRUG

JAB-21822 administered orally as a tablet.

Phase 1b Dose EscalationPhase 2 Dose Expansion, Cohort 1Phase 2 Dose Expansion, Cohort 2
CetuximabDRUG

Cetuximab administered as an intravenous (IV) infusion.

Phase 1b Dose EscalationPhase 2 Dose Expansion, Cohort 1Phase 2 Dose Expansion, Cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Research site31

Beijing, Beijing Municipality, 100021, China

Location

Research site01

Beijing, Beijing Municipality, 100101, China

Location

Research site02

Beijing, Beijing Municipality, 100101, China

Location

Research site12

Beijing, Beijing Municipality, 100101, China

Location

Research site13

Nanning, Guangxi, 530021, China

Location

Research site06

Harbin, Heilongjiang, 150000, China

Location

Research site05

Zhengzhou, Henan, 450000, China

Location

Research site07

Zhengzhou, Henan, 450000, China

Location

Research site18

Wuhan, Hubei, 430079, China

Location

Research site11

Changsha, Hunan, 410000, China

Location

Research site29

Changsha, Hunan, 410000, China

Location

Research site09

Nanjing, Jiangsu, 210000, China

Location

Research site08

Nanchang, Jiangxi, 330000, China

Location

Research site16

Linyi, Shandong, 276002, China

Location

Research site28

Shanghai, Shanghai Municipality, 200032, China

Location

Research site23

Xi’an, Shanxi, 710000, China

Location

Research site19

Hangzhou, Zhejiang, 310005, China

Location

Related Publications (1)

  • Li J, Wang Z, Huang J, Ba Y, Cao B, Luo S, Li W, Bai C, Song Z, Xiong J, Zhu L, An G, Zhang Y, Li Z, Li Y, Gu Y, Hu C, Li X, Huang C, Fu Q, Yin X, Liang X, Zhong D, Shi H, Li X, Li Z, Liu L, Wang F, Liang R, Xia G, Wang Z, Wang-Gillam A, Ding Y, Rao Z, Pan W, Lu S, Sun X, Shen L. Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials. Lancet Gastroenterol Hepatol. 2026 Feb;11(2):110-123. doi: 10.1016/S2468-1253(25)00267-5. Epub 2025 Dec 1.

    PMID: 41344351DERIVED

MeSH Terms

Conditions

Appendiceal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Cecal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Shen Lin Master of medicine

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2021

First Posted

January 18, 2022

Study Start

February 17, 2022

Primary Completion

April 30, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

CN(17)