Clinical trial · Interventional
SC-101 in Subjects With Advanced NECTIN4-Amplified Cancers
A Phase IIa Clinical Study to Assess the Efficacy and Safety of SC-101 in Patients With Advanced Malignant Tumors Positive for NECTIN4 Gene Amplification
NCT07080619CI-TRIAL-00094962not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is an open-label, multicenter Phase IIa trial to evaluate the efficacy and safety of SC-101 monotherapy in patients with locally advanced or metastatic malignant tumors who are positive for NECTIN4 gene amplification.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HR+ Breast Cancer | — | UNRESOLVED | — |
| TNBC - Triple-Negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SC-101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TNBC, HR+HER2- BC, and other tumors
- description
- Receive 7.5 mg/m² of SC-101 intravenously once weekly (QW).
- interventionNames
- Drug: SC-101
Primary outcomes (1)
- measure
- cORR
- timeFrame
- Baseline (Day -28 to Day -1); tumor response will be evaluated every 8 weeks (±7 days) from the first dose of study treatment to the data cut-off date, up to 24 months.
- description
- Investigator-assessed confirmed objective response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Age between 18 and 75 years (inclusive), regardless of gender. ECOG performance status of 0-1. Expected survival of more than 3 months, as assessed by the investigator. Fertile participants must agree to use contraception. Able to understand the trial requirements and willing and able to comply with the trial and follow-up procedures. Adequate bone marrow and organ function. NECTIN-4 gene amplification positive. Exclusion Criteria: Unstable central nervous system tumors. Adverse reactions from previous anticancer treatments have not recovered to a CTCAE 5.0 grade ≤1. A history of severe cardiovascular or cerebrovascular disease.
References
Publications (0)
Data not yet available
No reference posted for this study.