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

Last updated: April 3, 2025
Sponsor: Allist Pharmaceuticals, Inc.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Digestive System Neoplasms

Colorectal Cancer

Treatment

JAB-21822

Cetuximab

Clinical Study ID

NCT05194995
JAB-21822-1007
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must be able to provide an archived tumor sample

  • Histologically or cytologically confirmed advanced colorectal cancer, advanced smallintestinal 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

Exclusion Criteria:

  • Has brain metastases, except if treated and no evidence of radiographic progressionor 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

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: JAB-21822
Phase: 1/2
Study Start date:
February 17, 2022
Estimated Completion Date:
January 31, 2026

Study Description

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.

Connect with a study center

  • Research site27

    Bengbu, Anhui 233000
    China

    Site Not Available

  • Research site01

    Beijing, Beijing 100101
    China

    Site Not Available

  • Research site02

    Beijing, Beijing 100101
    China

    Site Not Available

  • Research site12

    Beijing, Beijing 100101
    China

    Site Not Available

  • Research site31

    Beijing, Beijing 100021
    China

    Site Not Available

  • Research site20

    Xiamen, Fujian 361003
    China

    Site Not Available

  • Research site26

    Foshan, Guangdong 528300
    China

    Site Not Available

  • Research site03

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Research site30

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Research site13

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Research site06

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • Research site05

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Research site07

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Research site18

    Wuhan, Hubei 430079
    China

    Site Not Available

  • Research site11

    Changsha, Hunan 410000
    China

    Site Not Available

  • Research site29

    Changsha, Hunan 410000
    China

    Site Not Available

  • Research site09

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Research site24

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Research site32

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Research site25

    Yangzhou, Jiangsu 225000
    China

    Site Not Available

  • Research site08

    Nanchang, Jiangxi 330000
    China

    Site Not Available

  • Research site04

    Changchun, Jilin 130000
    China

    Site Not Available

  • Research site10

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • Research site14

    Yinchuan, Ningxia 750003
    China

    Site Not Available

  • Research site15

    Jinan, Shandong 250117
    China

    Site Not Available

  • Research site16

    Linyi, Shandong 276002
    China

    Site Not Available

  • Research site28

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Research site22

    Xi'an, Shanxi 710000
    China

    Site Not Available

  • Research site23

    Xi'an, Shanxi 710000
    China

    Site Not Available

  • Research site17

    Chengdu, Sichuan 610042
    China

    Site Not Available

  • Research site19

    Hangzhou, Zhejiang 310005
    China

    Site Not Available

  • Research site21

    Hangzhou, Zhejiang 310005
    China

    Site Not Available

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