An Explorative Study of HRS-2189 Combined With Adebrelimab and BP102 for Metastatic Colorectal Cancer

NCT07061210 | Not Yet Recruiting Phase 2

• 1 other identifier: CRC-IIT-HRS2189-SHR1316
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety and efficacy of HRS-2189 combined with Adebrelimab and BP102 in the treatment of metastatic colorectal cancer

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  the proportion of patients with complete response or partial response, using RECIST v 1.1.

  assessed up to 1 year

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  assessed up to 1 year

• Overall survival (OS)

  assessed up to 2 year

• Disease Control Rate (DCR)

  assessed up to 1 year

• Adverse events (AEs)

  From the first drug administration to within 90 days for the last dose

Study Arms (1)

HRS-2189 + Adebrelimab + BP102

EXPERIMENTAL

Drug: HRS-2189; Drug: Adebrelimab; Drug: BP102

Interventions

HRS-2189 DRUG

HRS-2189

HRS-2189 + Adebrelimab + BP102

Adebrelimab DRUG

Adebrelimab

HRS-2189 + Adebrelimab + BP102

BP102 DRUG

BP102

HRS-2189 + Adebrelimab + BP102

Eligibility Criteria

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

You may qualify if:

• years; 2.Histological confirmed metastatic colorectal cancer; 3.ECOG PS 0-1; 4.At least one measurable lesion (according to RECIST1.1); 5.Patients voluntarily enroll in the study.

You may not qualify if:

• The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• Symptomatic brain or meningeal metastases (except for those whose BMS disease is stable for at least 4 weeks);
• Allergy to the study drug or any of its excipients;
• Prior treatments or medications received before the first study treatment as follows:
• Major surgery within 28 days before treatment (tissue biopsy for diagnostic purposes is allowed).
• Use of immunosuppressive drugs within 7 days before treatment, excluding intranasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10 mg/day of prednisone or an equivalent dose of other corticosteroids);
• Administration of immunomodulatory drugs (such as thymosin, interferon, interleukin) within 3 weeks before treatment;
• Vaccination with live attenuated vaccines within 28 days before treatment;
• Other systemic anti-tumor therapies within 28 days before treatment;
• Any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence;
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Active infection or unexplained fever \>38.5°C within 4 weeks before the first dose or on the day of the first dose (fever due to tumor may be included in the study at the investigator's discretion)；
• Within 6 months prior to study entry, any of the following conditions: myocardial infarction, severe/unstable angina, NYHA Class 2 or higher cardiac insufficiency, or clinically significant supraventricular/ventricular arrhythmia requiring clinical intervention; poorly controlled hypertension despite medication;
• History of severe bleeding (\>30 mL per episode) within 3 months, hemoptysis (\>5 mL per episode) within 1 month, or arterial/venous thrombotic events within 6 months before the first dose;
• Inability to swallow the study drug, or presence of factors affecting drug administration and absorption such as chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) or intestinal obstruction;

Sponsors & Collaborators

• Fudan University: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-06