SHR-1701 Combined with SHR2554 and BP102 for MCRC

NCT06679673 | Not Yet Recruiting Phase 2

• 1 other identifier: CRC-IIT-SHR1701-SHR2554-BP102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Response to oncologic treatment in mCRC is currently limited.

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 (3)

• Disease Control Rate (DCR)

  assessed up to 1 year

• Progression-Free Survival (PFS)

  assessed up to 1 year

• Overall survival (OS)

  assessed up to 2 year

Study Arms (1)

SHR-1701+BP102±SHR2554

EXPERIMENTAL

The first 6 subjects will be treated with SHR-1701+BP102, and the subsequent subjects will be treated with SHR-1701+BP102+SHR2554

Drug: SHR-1701; Drug: BP102; Drug: SHR2554

Interventions

SHR-1701 DRUG

SHR-1701

SHR-1701+BP102±SHR2554

BP102 DRUG

BP102

SHR-1701+BP102±SHR2554

SHR2554 DRUG

SHR2554

SHR-1701+BP102±SHR2554

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;
• Histological confirmed metastatic colorectal cancer;
• ECOG PS 0-1;
• At least one measurable lesion (according to RECIST1.1);
• Adequate hepatic, renal, coagulation, and hematologic functions;
• Agree to use contraception during the study and 3 months after the end of the study. Negative serum pregnancy test at screening for women of childbearing potential;
• 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 treatment with immune checkpoint inhibitors;
• Received the following treatments before the first study treatment;
• Major surgery within 28 days before treatment (tissue biopsy for diagnostic purposes is permitted).
• Prior use of immunosuppressive medications, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/d prednisone or equivalent pharmacologic doses of other corticosteroids) within 7 days before treatment;
• Received immunomodulatory drugs within 3 weeks before treatment;
• Received live attenuated vaccine within 28 days before treatment;
• Receipt of other antitumor systemic therapy within 28 days prior to treatment;
• Presence of any active autoimmune disease or history of autoimmune disease with expected relapse;
• A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
• Human immunodeficiency virus (HIV) infection or known AIDS, untreated active hepatitis, HBV-DNA ≥ 2500 IU/ml and abnormal liver function; hepatitis C or co-infection with hepatitis B and hepatitis C;
• A history of interstitial lung disease or non-infectious pneumonia, etc.;
• Within 6 months before enrollment, the following conditions: myocardial infarction, severe/unstable angina, NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; hypertension with poorly controlled by medications;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Colorectal Surgery Fudan University Shanghai Caner Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

SHR-1701

Central Study Contacts

Ye Xu, Prof.

CONTACT

+86-21-6417-5590; xu_shirley021@163.com

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: November 6, 2024
• First Posted: November 7, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)