Status:
RECRUITING
Study SC-101 in Subjects With Advanced Malignancies
Lead Sponsor:
Tianjin ConjuStar Biologics Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in subjects with advanced or metastatic solid tumors.
Detailed Description
This study is the first-in-human (FIH), multi-center, open-label trial of SC-101, including the dose escalation and expansion phases. The dose escalation study is primarily designed to assess the saf...
Eligibility Criteria
Inclusion
- Subjects voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).
- 18 to 80 years of age at the time of signature of the ICF, without gender limitation.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 3 months as assessed by the investigator.
- Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the study.
- Understand study requirements, and willing and able to comply with arrangements of study and follow-up procedures.
- Adequate Bone Marrow Reserve and Organ Functions.
- Subjects must have measurable disease according to RECIST (version 1.1).
- Histologically or cytologically confirmed advanced malignant solid tumors.
- For non-urothelial carcinoma patients enrolled in the dose expansion study: Subjects must have a positive expression of Nectin-4 in their tumor samples as confirmed by the central laboratory.
- Subjects are willing to follow study procedures.
Exclusion
- History of other malignancy(ies) within 3 years before signing the ICF, except for non-melanoma skin cancer, cervical carcinoma in situ, or other malignant tumors that are considered to have been cured.
- Any anticancer therapy, including any investigational drug, within 2 weeks before the first dose of the study drug.
- Uncontrolled central nervous system metastases.
- Prior treatment with Nectin-4-targeting anti-cancer therapy.
- Preexisting treatment-related toxicity Grade ≥ 2 (except alopecia).
- Preexisting Grade ≥ 2 (as per CTCAE v5.0) sensory or motor neuropathy.
- Major surgery within 4 weeks prior to the first dose of the study drug.
- History of interstitial lung disease (ILD), preexisting ILD, or the suspected ILD that cannot be ruled out by imaging examination at screening.
- Preexisting active keratitis or corneal ulcerations.
- Preexisting serious dermatological diseases, or having experienced serious skin toxicities during the prior anti-cancer treatment (e.g., Stevens-Johnson syndrome, toxic Epidermal Necrolysis, etc.).
- Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of study drug, or fever within 14 days prior to the first dose of the study drug.
- History of uncontrolled diabetes mellitus.
- History of thromboembolic events and bleeding disorders ≤ 6 months (e.g.,deep vein thrombosis (DVT) or pulmonary embolism ( PE)) prior to the first dose of the study drug.
- Positive results of virus serology tests.
- History of serious cardiovascular and cerebrovascular diseases, including but not limited to:
- Serious cardiac arrhythmias or conduction abnormalities, such as ventricular arrhythmia require treatment, and grade 2 or 3 atrioventricular block.
- QTc prolongation to \>450 milliseconds (ms) in males and \>470 ms in females based on ECG.
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or transient ischemic attack (TIA) within 6 months prior to the first dose of the study drug.
- New myocardial infarction or unstable angina within 6 months before the first dose of the study drug.
- Uncontrolled hypertension.
- Require ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome P450 3A4 (CYP3A4) enzymes.
- Known sensitivity to any of the ingredients of the investigational product.
Key Trial Info
Start Date :
February 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06220838
Start Date
February 2 2024
End Date
September 1 2026
Last Update
July 29 2025
Active Locations (5)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
2
Hunan Cancer Hospital
Changsha, Hunan, China
3
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
4
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China