A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Refractory Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT07361003

Run by

Jiangsu Simcere Pharmaceutical Co., Ltd.

People needed

464

Starts

2025-11-12

Expected to finish

2028-07-01

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Confirmed by histological and/or cytological examination as unresectable metastatic colon or rectal adenocarcinoma;
• 2. At least one measurable tumor lesion (RECIST v1.1);
• 3. Previously received fluorouracil, oxaliplatin, and irinotecan based chemotherapy; had previously undergone or was unsuitable for anti-VEGF therapy. (For participants with RAS wild-type, had previously undergone or was unsuitable for anti-EGFR therapy.);
• 4. Refractory metastatic colorectal cancer having progressed on or are intolerant to the last systemic treatment;
• 5. Good organ and bone marrow function (no administration of hematopoietic growth factors, blood transfusion, or platelets within 14 days before screening hematology test);
• 6. RAS mutation status confirmed by testing tumor tissue and /or blood sample.

You may not qualify if…

• 1. Having a second active primary malignancy within the past 5 years;
• 2. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring local CNS-directed therapy (e.g., radiotherapy or surgery) or corticosteroid treatment within 2 weeks prior to the first administration of the study treatment;
• 3. Any active infection requiring systemic treatment within 2 weeks prior to the initiation of the study treatment;
• 4. Pleural effusion, pericardial effusion, or ascites that is uncontrolled or has required drainage or medical intervention within 4 weeks prior to the first administration of the study treatment;
• 5. Received systemic immuno suppressive therapy within 4 weeks prior to randomization (excluding prophylactic use or chronic low-dose steroids [≤20 mg/day prednisone equivalent dose]);
• 6. Currently taking or has recently taken (within 10 days prior to the first dose) aspirin (>325 mg/day);
• 7. Active or chronic hepatitis B (HBsAg or HBcAb positive and HBV DNA≥2000 IU/mL or ≥10000 copies/mL) or hepatitis C infection (HCV antibody positive and HCV RNA≥ULN);
• 8. Clinically significant cardiovascular disease within 6 months prior to the first administration of the study treatment;symptomatic coronary artery disease requiring medication; arrhythmia requiring medication (excluding asymptomatic atrial fibrillation with controlled ventricular rate); QTcF interval >470 ms at rest state; or uncontrolled hypertension or pulmonary hypertension;
• 9. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.); clinically significant bleeding events, arterial or deep venous thrombotic events, or superficial venous thrombosis and intermuscular venous thrombosis requiring intervention within 6 months prior to enrollment;
• 10. Participants with proteinuria (urine protein >2+ found during screening examinations; or urine protein 2+ with 24-hour urine protein quantification ≥1g/24h);
• 11. Participants with a history of intestinal obstruction (including incomplete intestinal obstruction) within 1 month prior to enrollment; participants with a history of abdominal fistula, gastrointestinal perforation, or abdominal abscess.

Where it is running

• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Harbin Medical University University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
• Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (enrolling)
• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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