Actively Recruiting
A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2026-01-22
464
Participants Needed
6
Research Sites
137 weeks
Total Duration
On this page
Sponsors
J
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead Sponsor
J
Jiangsu Simcere Biologics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. The primary goal of Phase III Study is to evaluate the efficacy of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. Researchers will compare Suvemcitug + trifluridine/tipiracil tablets with placebo (a look-alike substance that contains no drug)+ trifluridine/tipiracil tablets to see if Suvemcitug + trifluridine/tipiracil tablets works better in treating refractory metastatic colorectal cancer.
CONDITIONS
Official Title
A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed unresectable metastatic colon or rectal adenocarcinoma by tissue or cell examination
- At least one measurable tumor lesion according to RECIST v1.1 criteria
- Previously treated with fluorouracil, oxaliplatin, and irinotecan chemotherapy
- Previously received or unsuitable for anti-VEGF therapy; for RAS wild-type, also previously received or unsuitable for anti-EGFR therapy
- Cancer has progressed or is intolerant to the last systemic treatment
- Good organ and bone marrow function without recent blood growth factors, transfusion, or platelets within 14 days before screening
- RAS mutation status confirmed by tumor tissue or blood testing
You will not qualify if you...
- Second active primary cancer within the last 5 years
- Symptomatic brain metastases or brain metastases requiring recent treatment or steroids
- Active infection needing treatment within 2 weeks before starting study treatment
- Uncontrolled or recently drained fluid around lungs, heart, or abdomen within 4 weeks before treatment
- Systemic immunosuppressive therapy within 4 weeks before randomization, except low-dose steroids
- Taking or recently took high-dose aspirin (>325 mg/day) within 10 days before first dose
- Active or chronic hepatitis B or hepatitis C infection above specified viral levels
- Significant heart disease within 6 months prior to treatment or uncontrolled blood pressure or arrhythmia
- Known bleeding or clotting disorders or recent serious bleeding or clotting events within 6 months
- Protein in urine above specified levels during screening
- History of intestinal blockage, abdominal fistula, gastrointestinal perforation, or abscess within specified recent timeframes
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
2
Harbin Medical University University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
3
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
4
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
Actively Recruiting
5
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
6
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
X
Xueyan Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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