A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients

NCT06497985 | Recruiting Phase 3

• 1 other identifier: CDM303
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

A randomised, open-label, multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  From randomization to the date of death from any cause.

  Up to approximately 2 years

Secondary Outcomes (9)

• Progression Free Survival (PFS)

  Up to approximately 2 years

• Overall response rate (ORR)

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

• Disease control rate (DCR)

  Up to approximately 2 years

• Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale Score

  Up to approximately 2 years

Study Arms (2)

tucidinostat+sintilimab+bevacizumab

EXPERIMENTAL

Drug: Tucidinostat; Drug: Sintilimab; Drug: Bevacizumab

fruquintinib

ACTIVE COMPARATOR

Drug: Fruquintinib

Interventions

Tucidinostat DRUG

30mg orally BIW

Also known as: Chidamide

tucidinostat+sintilimab+bevacizumab

Sintilimab DRUG

200 mg intravenously (IV) Q3W

tucidinostat+sintilimab+bevacizumab

Bevacizumab DRUG

7.5mg/kg intravenously (IV) Q3W

tucidinostat+sintilimab+bevacizumab

Fruquintinib DRUG

5mg orally QD

fruquintinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent for the study.
• Age ≥18 years and ≤75 years.
• Histologically or cytologically confirmed unresectable and metastatic colorectal adenocarcinoma.
• Has been previously treated and has shown disease progression or could not tolerate standard treatment, which must include fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (bevacizumab) or anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) .
• Have confirmed MSS or MSI-L, or pMMR.
• KRAS status must have been previously determined (mutant or wild-type) .
• Measurable disease per RECIST v1.1.
• ECOG PS 0 or 1.
• Adequate organ function.
• Expected survival \>12 weeks.

You may not qualify if:

• Prior use of HDAC inhibitor.
• Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway.
• Prior use of small-molecule tyrosine kinase inhibitor of VEGF receptors.
• Received any anti-tumor therapy or investigational agent and device within 28 days before the first dose of study treatment.
• Received radiotherapy within 28 days before the first dose of study treatment.
• If randomized into the control group, it is planned to use the combination of tucidinostat with PD-1 inhibitor and bevacizumab after the end of study treatment.
• History of autoimmune diseases requiring systemic treatment within 2 years before the first dose of study treatment.
• Known history of primary immunodeficiency.
• Received systemic immunosuppressive drugs within 28 days before the first dose of study treatment.
• Received systemic immunostimulatory drugs within 28 days before the first dose of study treatment.
• Received major surgery within 28 days before the first dose of study treatment.
• Received a live vaccine within 28 days before the first dose of study treatment or planned to receive during the study period.
• Has not recovered ( ≤ Grade 1 defined by CTCAE V5.0) from AEs due to prior anti-cancer therapy.
• Has uncontrolled diabetes assessed by investigators within 7 days before the first dose of study treatment.
• Has symptomatic and untreated central nervous system (CNS) metastases.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Rui-Hua Xu

Guangzhou, Guangdong, 510050, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; sintilimab; Bevacizumab; HMPL-013

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rui-Hua Xu

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinhao Wang

CONTACT

+86 0755-36993550; xinhwang@chipscreen.com

Rui-Hua Xu

CONTACT

xurh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 12, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)