Actively Recruiting
Phase I Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of SC-102 in Patients With Advanced or Metastatic Solid Tumors Expressing EphA2
Led by Tianjin ConjuStar Biologics Co., Ltd. · Updated on 2025-07-29
120
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SC-102, a peptide drug conjugate targeting EphA2, in people with advanced or metastatic solid tumors that express this protein. This phase I, multi-center, open-label trial aims to assess the safety, pharmacokinetics (how the drug moves through the body), and anti-cancer effects of SC-102. The study includes both a dose escalation phase to find safe and tolerable doses and a dose expansion phase to evaluate clinical activity of the drug. Participants will receive SC-102 either once weekly or once every two weeks as a single treatment during 4-week cycles. The dose escalation part determines the recommended dose(s) for the expansion phase. The dose expansion phase focuses on measuring the drug's clinical impact. Treatment continues until disease progression, unacceptable side effects, or other criteria are met. Throughout the study, participants will be closely monitored with safety assessments including treatment-emergent adverse events. Researchers will evaluate responses using established criteria for solid tumors and measure drug levels in the blood. Follow-up may continue for up to two years to assess outcomes like duration of response and disease control. This comprehensive monitoring helps understand SC-102's effects and safety profile in this patient population.
CONDITIONS
Brief Title
Study of SC-102 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily agree to participate and sign informed consent.
- Aged 18 to 75 years at the time of consent, any gender.
- 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 agree to use effective contraception during the study.
- Willing and able to comply with the study protocol and procedures.
- Acceptable kidney, liver, blood, and clotting function.
- Measurable disease according to RECIST v1.1 criteria.
- Histologically confirmed metastatic or recurrent malignant solid tumors with exhausted standard treatment options.
- Confirmation of EphA2 expression is required for dose expansion study participants but not for dose escalation participants.
You will not qualify if you...
- History of other cancers within 3 years except certain cured or in situ cancers.
- Any anticancer treatment or experimental therapy within 4 weeks before first dose.
- Radiotherapy involving more than 30% of bone marrow or extensive radiotherapy within 4 weeks, or local radiotherapy within 7 days before first dose.
- Uncontrolled brain metastases.
- Existing treatment-related toxicities Grade 2 or higher except stable alopecia and hypothyroidism.
- Sensory or motor neuropathy Grade 2 or higher.
- Major surgery within 4 weeks prior to first dose.
- History or suspicion of interstitial lung disease not ruled out by imaging.
- Serious skin diseases or severe skin toxicities from prior anti-cancer therapy.
- Active infection requiring systemic therapy within 14 days prior to first dose.
- History of thromboembolic events or bleeding disorders within 3 months before first dose.
- Positive viral serology tests.
- Serious cardiovascular or cerebrovascular diseases.
- Treatment with strong CYP3A4 enzyme inhibitors or inducers within 2 weeks before first dose.
- Known sensitivity to any ingredients of SC-102.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants receive SC-102 as a single agent once weekly or once biweekly on a 4-week cycle at the selected dose.
Weekly or biweekly visits depending on dosing schedule
Duration - Up to 2 years after treatment ends
Participants are monitored for safety and clinical outcomes up to 2 years after treatment ends.
Visits scheduled as needed for safety and disease assessments
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
Jing Wu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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