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

NCT05194995 · tracked via the Priya Life Science China tracker

Sponsor

Allist Pharmaceuticals, Inc.

Phase

Phase 1/2

Started

2022-02-17

Last updated

2026-03-16

Condition(s) studied

Advanced Colorectal CancerSmall Intestinal CancerAppendiceal Cancer

Investigational drug(s) / intervention(s)

JAB-21822 →Cetuximab →

JAB-21822: JAB-21822 administered orally as a tablet.

Cetuximab: Cetuximab administered as an intravenous (IV) infusion.

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Dose Escalation phase: Number of participants with dose-limiting toxicities (DLTs) — 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.
Dose Expansion phase: Overall response rate (ORR) — 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.

Trial sites (17)

Facility	City	Region
Research site31	Beijing	Beijing Municipality
Research site01	Beijing	Beijing Municipality
Research site02	Beijing	Beijing Municipality
Research site12	Beijing	Beijing Municipality
Research site13	Nanning	Guangxi
Research site06	Harbin	Heilongjiang
Research site05	Zhengzhou	Henan
Research site07	Zhengzhou	Henan
Research site18	Wuhan	Hubei
Research site11	Changsha	Hunan
Research site29	Changsha	Hunan
Research site09	Nanjing	Jiangsu
Research site08	Nanchang	Jiangxi
Research site16	Linyi	Shandong
Research site28	Shanghai	Shanghai Municipality
Research site23	Xi’an	Shanxi
Research site19	Hangzhou	Zhejiang

More Allist Pharmaceuticals, Inc. trials in China

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A Study of JAB-21822 in Adult Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation in China Active, not recruiting

A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation. Recruiting

Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05194995 on ClinicalTrials.gov ↗ ← All trials in China