JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation
NCT ID: NCT05194995
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2022-02-17
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1b Dose Escalation
Dose escalation of JAB-21822 to determine maximum tolerated dose of JAB-21822 in combination with cetuximab.
JAB-21822
JAB-21822 administered orally as a tablet.
Cetuximab
Cetuximab administered as an intravenous (IV) infusion.
Phase 2 Dose Expansion, Cohort 1
Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.
JAB-21822
JAB-21822 administered orally as a tablet.
Cetuximab
Cetuximab administered as an intravenous (IV) infusion.
Phase 2 Dose Expansion, Cohort 2
Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced small intestinal cancer and advanced appendiceal cancer.
JAB-21822
JAB-21822 administered orally as a tablet.
Cetuximab
Cetuximab administered as an intravenous (IV) infusion.
Interventions
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JAB-21822
JAB-21822 administered orally as a tablet.
Cetuximab
Cetuximab administered as an intravenous (IV) infusion.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Allist Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shen Lin Master of medicine
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Research site31
Beijing, Beijing Municipality, China
Research site01
Beijing, Beijing Municipality, China
Research site02
Beijing, Beijing Municipality, China
Research site12
Beijing, Beijing Municipality, China
Research site13
Nanning, Guangxi, China
Research site06
Harbin, Heilongjiang, China
Research site05
Zhengzhou, Henan, China
Research site07
Zhengzhou, Henan, China
Research site18
Wuhan, Hubei, China
Research site11
Changsha, Hunan, China
Research site29
Changsha, Hunan, China
Research site09
Nanjing, Jiangsu, China
Research site08
Nanchang, Jiangxi, China
Research site16
Linyi, Shandong, China
Research site28
Shanghai, Shanghai Municipality, China
Research site23
Xi’an, Shanxi, China
Research site19
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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JAB-21822-1007
Identifier Type: -
Identifier Source: org_study_id
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