Trial · NCT07361003
A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
NCT07361003, Phase 3, Recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer. Trials, record NCT07361003. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07361003
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
- NCT number
- NCT07361003
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 464 participants, estimated
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Conditions
- Refractory Metastatic Colorectal Cancer
- Interventions
- Suvemcitug injection, trifluridine/tipiracil tablets, Suvemcitug placebo injection, trifluridine/tipiracil tablets
- First posted
- 2026-01-22
- Last updated
- 2026-01-22
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib: dose limiting toxicity (DLT) | At the end of Cycle 1 (each cycle is 28 days) | |
| Primary | Phase Ib: Adverse Events | 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 |
| Primary | Phase Ib: Tolerance | 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. |
| Primary | Phase III: overall survival (OS) | 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. |
| Secondary | Suvemcitug Serum concentration change over time of all participants | For about 6 cycles, each cycle is 28 days. | Area under the serum concentration versus time curve (AUC) |
| Secondary | Peak Suvemcitug serum concentration (Cmax) of all participants | For about 6 cycles, each cycle is 28 days | |
| Secondary | The time taken to reach peak Suvemcitug concentration after administration (Tmax) | For about 6 cycles, each cycle is 28 days | |
| Secondary | The time required for Suvemcitug concentration in the serum to decrease by half (t1/2) | For about 6 cycles, each cycle is 28 days | |
| Secondary | Serum anti-drug antibody (ADA) incidence of Suvemcitug | For about 6 cycles, each cycle is 28 days | The number of participants with anti-drug antibody (ADA) tested positive from blood |
| Secondary | Serum anti-drug antibody (ADA) duration of Suvemcitug | For about 6 cycles, each cycle is 28 days | Duration of ADA measures how long the antibody persists in the blood |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07361003
GET https://conductscience.org/api/trials/v1/NCT07361003/registered