RecruitingAdvanced Solid Tumor

Study SC-101 in Subjects With Advanced Malignancies

Eligible age

18–80 yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

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This study will evaluate the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in subjects with advanced or metastatic solid tumors.

Sponsor: Tianjin ConjuStar Biologics Co., Ltd.

✓ 1. Subjects voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).
✓ 2. 18 to 80 years of age at the time of signature of the ICF, without gender limitation.
✓ 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓ 4. Life expectancy of ≥ 3 months as assessed by the investigator.
✓ 5. Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the study.
✓ 6. Understand study requirements, and willing and able to comply with arrangements of study and follow-up procedures.
✓ 7. Adequate Bone Marrow Reserve and Organ Functions.
✓ 8. Subjects must have measurable disease according to RECIST (version 1.1).

✕ 1. 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.
✕ 2. Any anticancer therapy, including any investigational drug, within 2 weeks before the first dose of the study drug.
✕ 3. Uncontrolled central nervous system metastases.
✕ 4. Prior treatment with Nectin-4-targeting anti-cancer therapy.
✕ 5. Preexisting treatment-related toxicity Grade ≥ 2 (except alopecia).
✕ 6. Preexisting Grade ≥ 2 (as per CTCAE v5.0) sensory or motor neuropathy.
✕ 7. Major surgery within 4 weeks prior to the first dose of the study drug.
✕ 8. History of interstitial lung disease (ILD), preexisting ILD, or the suspected ILD that cannot be ruled out by imaging examination at screening.

Source: ClinicalTrials.gov · NCT06220838 · last updated 2025-07-29