A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Suvemcitug injection, trifluridine/tipiracil tablets
- Suvemcitug placebo injection, trifluridine/tipiracil tablets
Treatment groups
464 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead sponsor
Jiangsu Simcere Biologics Co., Ltd
Collaborator
Source ClinicalTrials.gov