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

January 14, 2026 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

A Phase Ib/III Study of Suvemcitug Plus Trifluridine/Tipiracil Tablets (FTD/TPI) Versus Placebo Plus Trifluridine/Tipiracil Tablets in Participants With Refractory Metastatic Colorectal Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will enroll approximately 464 participants (30 for Phase Ib and 434 for Phase III stage) with refractory metastatic colorectal cancer who have previously received fluorouracil, oxaliplatin, and irinotecan-based chemotherapy, and who have either previously received or are unsuitable for anti-vascular endothelial growth factor (VEGF) therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type).

For Phase Ib Study, all 30 participants will be receiving the treatment with Suvemcitug in combination with trifluridine/tipiracil tablets. For Phase III Study, approximately 434 participants will be randomly assigned in a 1:1 ratio to two groups. One group will receive treatment with Suvemcitug + trifluridine/tipiracil tablets. The other group will receive the treatment with placebo + trifluridine/tipiracil tablets.

All participants will receive study treatment until they meet the criteria for treatment discontinuation. During study treatment period, investigators will evaluate the efficacy, safety and participants' quality of life. After treatment discontinuation, investigators will continue to follow up for subsequent treatment and survival information until the criteria for study discontinuation are met.

By the end of study, for participants who are still receiving study treatment, if their efficacy evaluation result is stable or response and they are tolerant to the treatment, then after obtaining approval from health regulatory authorities and ethics committees, they can continue study treatment by joining another extension study or in other ways as discussed by the sponsor.

Study Type

Interventional

Enrollment (Estimated)

464

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Principal Investigator:
          • Rongbo Lin
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Harbin Medical University University Cancer Hospital
        • Principal Investigator:
          • Yanqiao Zhang
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • the First Affiliated Hospital of Nanjing Medical University
        • Principal Investigator:
          • Yanhong Gu
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Cancer Hospital of Shandong First Medical University
        • Principal Investigator:
          • Shuqin Ni
        • Principal Investigator:
          • Zuoxing Niu
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Principal Investigator:
          • Ting Deng
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Principal Investigator:
          • Ying Yuan
        • Principal Investigator:
          • Kefeng Ding
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suvemcitug+ trifluridine/tipiracil tablets
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
Suvemcitug injection at 1.5mg/kg, Trifluridine/tipiracil tablets at 35 mg/m²
Placebo Comparator: Placebo+ trifluridine/tipiracil tablets
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
Suvemcitug placebo injection, Trifluridine/tipiracil tablets at 35 mg/m².

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase Ib: dose limiting toxicity (DLT)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
At the end of Cycle 1 (each cycle is 28 days)
Phase Ib: Adverse Events
Time Frame: From signing informed consent form until 28 days after the last dose of study treatment, up to about 18 months
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
Time Frame: From signing informed consent until 28 days after the last dose of study treatment, for up to 18 months
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)
Time Frame: For about 18 months from the randomization of the last participant
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suvemcitug Serum concentration change over time of all participants
Time Frame: For about 6 cycles, each cycle is 28 days.
Area under the serum concentration versus time curve (AUC)
For about 6 cycles, each cycle is 28 days.
Peak Suvemcitug serum concentration (Cmax) of all participants
Time Frame: For about 6 cycles, each cycle is 28 days
For about 6 cycles, each cycle is 28 days
The time taken to reach peak Suvemcitug concentration after administration (Tmax)
Time Frame: For about 6 cycles, each cycle is 28 days
For about 6 cycles, each cycle is 28 days
The time required for Suvemcitug concentration in the serum to decrease by half (t1/2)
Time Frame: For about 6 cycles, each cycle is 28 days
For about 6 cycles, each cycle is 28 days
Serum anti-drug antibody (ADA) incidence of Suvemcitug
Time Frame: For about 6 cycles, each cycle is 28 days
The number of participants with anti-drug antibody (ADA) tested positive from blood
For about 6 cycles, each cycle is 28 days
Serum anti-drug antibody (ADA) duration of Suvemcitug
Time Frame: For about 6 cycles, each cycle is 28 days
Duration of ADA measures how long the antibody persists in the blood
For about 6 cycles, each cycle is 28 days
Serum anti-drug antibody (ADA) titer of Suvemcitug
Time Frame: For about 6 cycles, each cycle is 28 days
ADA titer measures how much anti-drug antibody is present in the blood
For about 6 cycles, each cycle is 28 days
Objective Response Rate (ORR) of all participants
Time Frame: From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months.
Proportion of participants who have a complete or partial response relative to baseline as assessed according to RECIST 1.1 criteria
From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months.
Duration of response (DoR) of all participants
Time Frame: From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months
Disease control rate (DCR) of all participants
Time Frame: From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months.
Proportion of participants who have a complete or partial response, or stable disease relative to baseline as assessed according to RECIST 1.1 criteria
From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months.
Progression free survival (PFS) of all participants
Time Frame: From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months.
From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months.
Phase Ib: overall survival (OS)
Time Frame: For about 18 months from the randomization of the last participant
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
Phase III: Adverse Events
Time Frame: From signing informed consent form until 28 days after the last dose of study treatment, for about 18 months.
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, for about 18 months.
Phase III: quality of life - EORTC QLQ-C30
Time Frame: Questionnaires will be collected from participants at baseline, and all efficacy evaluation visits, for up to 18 months
Quality of life evaluated by participant reported questionnaires: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 .
Questionnaires will be collected from participants at baseline, and all efficacy evaluation visits, for up to 18 months
Phase III: quality of life - Euro Qol (EQ)-5D
Time Frame: Questionnaires will be collected from participants at baseline, and all efficacy evaluation visits, for up to 18 months
Evaluated by participant reported questionnaires: EuroQol- 5 Dimension Questionnaire.
Questionnaires will be collected from participants at baseline, and all efficacy evaluation visits, for up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborators

Jiangsu Simcere Biologics Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM0063-302
  • CTR20254831 (Registry Identifier: Center for drug Evaluation, NMPA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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