Actively Recruiting
Study SC-101 in Subjects With Advanced Malignancies
Led by Tianjin ConjuStar Biologics Co., Ltd. · Updated on 2025-07-29
100
Participants Needed
5
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in subjects with advanced or metastatic solid tumors.
CONDITIONS
Official Title
Study SC-101 in Subjects With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must voluntarily agree to participate and sign the informed consent form.
- Age between 18 and 80 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months as assessed by the investigator.
- Women and men of childbearing potential must agree to use effective contraception during the study.
- Ability to understand study requirements and willingness to comply with study and follow-up procedures.
- Adequate bone marrow and organ function.
- Measurable disease according to RECIST version 1.1.
- Histologically or cytologically confirmed advanced malignant solid tumors.
- For non-urothelial carcinoma patients in the dose expansion phase, tumors must express Nectin-4 as confirmed by central lab.
- Willingness to follow all study procedures.
You will not qualify if you...
- History of other malignancies within 3 years before consent, except cured non-melanoma skin cancer, cervical carcinoma in situ, or other cured tumors.
- Any anticancer therapy, including investigational drugs, within 2 weeks before the first dose.
- Uncontrolled central nervous system metastases.
- Prior treatment with Nectin-4-targeting anticancer therapy.
- Preexisting treatment-related toxicities grade 2 or higher, except alopecia.
- Preexisting sensory or motor neuropathy grade 2 or higher.
- Major surgery within 4 weeks before the first dose.
- History or suspicion of interstitial lung disease not ruled out by imaging.
- Active keratitis or corneal ulcers.
- Serious dermatological diseases or serious skin toxicities from prior treatments.
- Receiving systemic antimicrobial treatment for active infection or fever within 14 days before the first dose.
- History of uncontrolled diabetes mellitus.
- History of thromboembolic or bleeding events within 6 months before the first dose.
- Positive virus serology tests.
- Serious cardiovascular or cerebrovascular diseases including serious arrhythmias, QTc prolongation, recent acute coronary syndrome, heart failure, aortic dissection, stroke, transient ischemic attack, recent myocardial infarction, unstable angina, or uncontrolled hypertension.
- Need for ongoing treatment with strong CYP3A4 inhibitors or inducers.
- Known sensitivity to any ingredients of SC-101.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
3
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
4
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
5
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
J
Jing Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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