TNBC - Triple-Negative Breast CancerPhase 2NCT07080619
SC-101 in Subjects With Advanced NECTIN4-Amplified Cancers
A Phase 2 study testing SC-101 in people with TNBC - Triple-Negative Breast Cancer and HR+ Breast Cancer, run by Tianjin ConjuStar Biologics Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer, HR+ Breast Cancer
- What is being tested?
- SC-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2025to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Hongxia Wang, MD, 021-38196379, whx365@126.com
Hongxia Wang, MD
About this study
Official title: 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
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.
Read the detailed description
The study will include multiple cohorts: triple-negative breast cancer (TNBC), HR-positive HER2-negative breast cancer, and other solid tumors.
Participants will receive SC-101 at a dose of 7.5 mg/m² once weekly, with treatment cycles lasting 28 days. The study aims to assess tumor response and safety until disease progression or other reasons for treatment discontinuation.
Eligibility requires patients to have locally advanced or metastatic tumors that have either relapsed after standard treatment, are resistant to treatment, or are not amenable to standard treatment. NECTIN4 gene amplification must be confirmed via tumor tissue testing.
Imaging assessments will be conducted every 8 weeks to evaluate tumor response. Safety follow-up will be performed 30 days after the last dose, with additional survival follow-ups every 12 weeks thereafter.
- Being tested
- SC-101
- Keywords
- SC-101
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC-101Drug
Receive 7.5 mg/m² of SC-101 intravenously once weekly (QW).
| Study group | Role | What they receive |
|---|---|---|
| TNBC, HR+HER2- BC, and other tumors | Experimental | Receive 7.5 mg/m² of SC-101 intravenously once weekly (QW). Receives: Drug: SC-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
cORR
Investigator-assessed confirmed objective response rate
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start26 Aug 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin ConjuStar Biologics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080619
- Sponsor's protocol ID
- SC-101-201
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data sharing plan has not been determined yet and will be further clarified after the study begins.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07080619
- Acronym / sponsor ID
- SC-101-201
- Keywords
- SC-101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin ConjuStar Biologics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will include multiple cohorts: triple-negative breast cancer (TNBC), HR-positive HER2-negative breast cancer, and other solid tumors.
Participants will receive SC-101 at a dose of 7.5 mg/m² once weekly, with treatment cycles lasting 28 days. The study aims to assess tumor response and safety until disease progression or other reasons for treatment discontinuation.
Eligibility requires patients to have locally advanced or metastatic tumors that have either relapsed after standard treatment, are resistant to treatment, or are not amenable to standard treatment. NECTIN4 gene amplification must be confirmed via tumor tissue testing.
Imaging assessments will be conducted every 8 weeks to evaluate tumor response. Safety follow-up will be performed 30 days after the last dose, with additional survival follow-ups every 12 weeks thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNBC, HR+HER2- BC, and other tumors | Experimental | Drug: SC-101Receive 7.5 mg/m² of SC-101 intravenously once weekly (QW). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC-101Receive 7.5 mg/m² of SC-101 intravenously once weekly (QW). | Drug | TNBC, HR+HER2- BC, and other tumors |
Primary outcome
cORR
Time frame: 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.
Investigator-assessed confirmed objective response rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided. The data sharing plan has not been determined yet and will be further clarified after the study begins.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SC-101 in people with TNBC - Triple-Negative Breast Cancer and HR+ Breast Cancer, run by Tianjin ConjuStar Biologics Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Wu (021-33670866, wujing@conjustar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cORR (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.