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Clinical Trials in China / NCT05194995
Active, not recruiting Phase 1/2

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
No
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)

FacilityCityRegionStatus
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

Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer 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
A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1 Recruiting
A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy（FIRMOST） Recruiting

Other trials for the same condition

A Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal Cancer Recruiting
Chemokine and Co-stimulatory Molecule-modified Mesenchymal Stem Cells for the Treatment of Advanced Colorectal Cancer Recruiting
Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10) Active, not recruiting
A Study of Cetuximabβ Combined With Envolimab and mFOLFOX6 in Subjects With Advanced Colorectal Cancer Starting soon
Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan Active, not recruiting
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