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

NCT07361003 | Recruiting Phase 3 DMC

• 2 other identifiers: SIM0063-302CTR20254831
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 6

Brief Summary

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

Refractory Metastatic Colorectal Cancer

Keywords

refractory metastatic colorectal cancer; Suvemcitug; trifluridine/tipiracil

Outcome Measures

Primary Outcomes (4)

• Phase Ib: dose limiting toxicity (DLT)

  At the end of Cycle 1 (each cycle is 28 days)

• Phase Ib: Adverse Events

  The incidence (number of participants) and severity of adverse events (AE) and serious adverse events (SAE) assessed by CTCAE v5.0

  From signing informed consent form until 28 days after the last dose of study treatment, up to about 18 months

• Phase Ib: Tolerance

  Number of participants who experienced adverse event related dose interruption, dose reduction and treatment discontinuation as assessed by investigators.

  From signing informed consent until 28 days after the last dose of study treatment, for up to 18 months

• Phase III: overall survival (OS)

  OS is the time interval from the date of randomization to death from any cause.

  For about 18 months from the randomization of the last participant

Secondary Outcomes (15)

• Suvemcitug Serum concentration change over time of all participants

  For about 6 cycles, each cycle is 28 days.

• Peak Suvemcitug serum concentration (Cmax) of all participants

  For about 6 cycles, each cycle is 28 days

• The time taken to reach peak Suvemcitug concentration after administration (Tmax)

  For about 6 cycles, each cycle is 28 days

• The time required for Suvemcitug concentration in the serum to decrease by half (t1/2)

  For about 6 cycles, each cycle is 28 days

• Serum anti-drug antibody (ADA) incidence of Suvemcitug

  For about 6 cycles, each cycle is 28 days

Study Arms (2)

Suvemcitug+ trifluridine/tipiracil tablets

EXPERIMENTAL

Participants will receive Suvemcitug injection (at 1.5mg/kg for Phase Ib; and a recommended dose level based on Phase Ib result will be used for Phase III part) on Day 1 and Day 15 of each cycle (28 days), and trifluridine/tipiracil tablets at 35 mg/m² on day 1-5, 8-12 of each cycle (28 days), until disease progression, intolerable adverse event, participant withdrawal, or meet other discontinuation criteria as described by the protocol.

Drug: Suvemcitug injection, trifluridine/tipiracil tablets

Placebo+ trifluridine/tipiracil tablets

PLACEBO COMPARATOR

Participants will receive Suvemcitug placebo injection on Day 1 and Day 15 of each cycle (28 days), and trifluridine/tipiracil tablets at 35 mg/m² on day 1-5, 8-12 of each cycle (28 days), until disease progression, intolerable adverse event, participant withdrawal, or meet other discontinuation criteria as described by the protocol.

Drug: Suvemcitug placebo injection, trifluridine/tipiracil tablets

Interventions

Suvemcitug injection, trifluridine/tipiracil tablets DRUG

Suvemcitug injection at 1.5mg/kg, Trifluridine/tipiracil tablets at 35 mg/m²

Suvemcitug+ trifluridine/tipiracil tablets

Suvemcitug placebo injection, trifluridine/tipiracil tablets DRUG

Suvemcitug placebo injection, Trifluridine/tipiracil tablets at 35 mg/m².

Placebo+ trifluridine/tipiracil tablets

Eligibility Criteria

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

You may qualify if:

• \. Confirmed by histological and/or cytological examination as unresectable metastatic colon or rectal adenocarcinoma;
• \. At least one measurable tumor lesion (RECIST v1.1);
• \. 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.);
• \. Refractory metastatic colorectal cancer having progressed on or are intolerant to the last systemic treatment;
• \. Good organ and bone marrow function (no administration of hematopoietic growth factors, blood transfusion, or platelets within 14 days before screening hematology test);
• \. RAS mutation status confirmed by testing tumor tissue and /or blood sample.

You may not qualify if:

• \. Having a second active primary malignancy within the past 5 years;
• \. 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;
• \. Any active infection requiring systemic treatment within 2 weeks prior to the initiation of the study treatment;
• \. 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;
• \. Received systemic immuno suppressive therapy within 4 weeks prior to randomization (excluding prophylactic use or chronic low-dose steroids \[≤20 mg/day prednisone equivalent dose\]);
• \. Currently taking or has recently taken (within 10 days prior to the first dose) aspirin (\>325 mg/day);
• \. 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);
• \. 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;
• \. 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;
• \. Participants with proteinuria (urine protein \>2+ found during screening examinations; or urine protein 2+ with 24-hour urine protein quantification ≥1g/24h);
• \. 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.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead
• Jiangsu Simcere Biologics Co., Ltd: collaborator

Study Sites (6)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Harbin Medical University University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Trifluridine; tipiracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Xueyan Li

CONTACT

+86-25-85566666; lixueyan1@zaiming.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study staff including the staff from sponsor, investigation site, contracted research organizations, blinded independent image review committee, site management organization and central lab are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is divided into two parts: the first part (Phase Ib) is open-label, and the second part (Phase III) is a randomized double-blind study. This study is currently in the first part.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: January 22, 2026
• Study Start: November 12, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2025-12

Locations

CN (6)