SC-101 in Subjects With Advanced NECTIN4-Amplified Cancers
Launched by TIANJIN CONJUSTAR BIOLOGICS CO., LTD. · Jul 20, 2025
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called SC-101 for people with advanced cancers that have a specific change in their genes called NECTIN4 amplification. The trial focuses on certain types of breast cancer, including triple-negative breast cancer and hormone receptor-positive breast cancer, especially when the cancer has spread or is hard to treat. The goal is to see how well SC-101 works on its own and to check if it is safe for patients.
To join this study, participants need to be between 18 and 75 years old, have a good overall health status, and have this specific NECTIN4 gene change in their cancer. They should also be expected to live at least three more months and be able to follow the study’s procedures, including using birth control if they can have children. People with unstable brain tumors or serious heart and blood vessel problems won’t be eligible. The trial is not recruiting yet, but those who participate can expect close monitoring of their health and how the treatment affects their cancer over time.
Gender
ALL
Eligibility criteria
- 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.
About Tianjin Conjustar Biologics Co., Ltd.
Tianjin Conjustar Biologics Co., Ltd. is an innovative biopharmaceutical company based in Tianjin, China, dedicated to the research, development, and commercialization of advanced biologic therapies. With a focus on addressing unmet medical needs, the company specializes in the development of monoclonal antibodies and other biologics for the treatment of various diseases, including cancer and autoimmune disorders. Leveraging a robust pipeline and cutting-edge technologies, Tianjin Conjustar Biologics aims to deliver high-quality, effective therapeutic solutions that enhance patient outcomes and contribute to the advancement of global healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported