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NCT06679673 | NOT YET RECRUITING | Colorectal Cancer Metastatic

SHR-1701 Combined with SHR2554 and BP102 for MCRC
Sponsor:

Fudan University

Information provided by (Responsible Party):

U

Brief Summary:

Response to oncologic treatment in mCRC is currently limited.

Condition or disease

Colorectal Cancer Metastatic

Intervention/treatment

SHR-1701

BP102

SHR2554

Phase

PHASE2

Detailed Description:

This is a single-center, open-labeled study exploring the efficacy and safety of SHR-1701 combined with SHR2554 and BP102 in the treatment of metastatic colorectal cancer (mCRC) .

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Explorative Study of SHR-1701 Combined with SHR2554 and BP102(bevacizumab) for Metastatic Colorectal Cancer.
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 18-75 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.
Exclusion Criteria
  • * 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;
  • 1. Major surgery within 28 days before treatment (tissue biopsy for diagnostic purposes is permitted).
  • 2. 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;
  • 3. Received immunomodulatory drugs within 3 weeks before treatment;
  • 4. Received live attenuated vaccine within 28 days before treatment;
  • 5. 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;
  • * A history of severe bleeding within 3 months (\>30 ml at a time) or hemoptysis within 1 month (\>5 ml at a time) or a thromboembolic event (including pulmonary embolism, cerebral infarction, etc.) within 12 months;
  • * Surgical treatment (except biopsy) within 6 weeks or unhealed surgical incision;
  • * Long-standing unhealed wounds or fractures that have not healed properly
  • * Imaging showing that the tumor has invaded a vital vascular perimeter or if, in the judgment of the investigator, the patient's tumor has a very high likelihood of invading a vital blood vessel and causing a fatal hemorrhage during therapy
  • * A history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months before the first study treatment
  • * Urine routine showed urine protein ≥2+, and 24-hour urine protein level \>1.0g;
  • * Unable to take the drug orally, or has a condition judged by the investigator to affect the absorption of the drug;
  • * Pregnancy, lactation, and unwillingness of reproductively active subjects to use effective contraception;
  • * Other conditions deemed by the investigator to be ineligible for inclusion in the study.
SHR-1701 Combined with SHR2554 and BP102 for MCRC

Location Details

NCT06679673

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How to Participate

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Locations

Not yet recruiting

China, Shanghai

Department of Colorectal Surgery Fudan University Shanghai Caner Center

Shanghai, Shanghai, China, 200032