Evaluating SC-102 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I trial assesses the safety, pharmacokinetics, and anti-cancer efficacy of SC-102, a peptide drug conjugate, in patients with advanced solid tumors. The study includes a dose escalation phase to determine the recommended dose and a dose expansion phase to evaluate clinical activity. Participants will receive SC-102 either weekly or biweekly as a single agent. The trial aims to provide insights into the tolerability and effectiveness of this novel treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).
2. Aged 18 to 75 years at the time of signature of the ICF, without gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score 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. Must be willing and able to comply with the protocol and study procedures.
7. Acceptable renal, hepatic, hematologic, and coagulation functions.
8. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
9. Metastatic recurrent histologically confirmed malignant solid tumors and exhausted all appropriate treatment options per local guidelines.
10. Confirmation of EphA2 expression by the central laboratory prior to enrollment is not required for participants enrolled in the dose escalation study, but required for participants enrolled in the dose expansion study.

Exclusion Criteria:

1. History of other malignancy(ies) within 3 years before signing the ICF, except for cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, papillary carcinoma of the thyroid gland, carcinoma in situ of the duct in situ, or other malignant tumors that have survived without disease for more than 5 years.
2. Any anticancer treatment, including experimental treatments, within 4 weeks before the first dose of the study drug.
3. Radiotherapy to \>30% of the bone marrow or extensive radiotherapy within 4 weeks, or local radiotherapy (e.g., radiation therapy to the thoracic spine and ribs) within 7 days, prior to the first dose of the study drug.
4. Uncontrolled central nervous system metastases.
5. Preexisting treatment-related toxicity Grade ≥ 2 (except Grade 2 alopecia and hypothyroidism stable with hormone replacement therapy).
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.
9. 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.).
10. Active infection requiring systemic therapy within 14 days prior to the first dose of the study drug.
11. History of thromboembolic events and bleeding disorders ≤ 3 months (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE)) prior to the first dose of the study drug.
12. Positive results of virus serology tests.
13. History of serious cardiovascular and cerebrovascular diseases.
14. Has received treatment within 2 weeks prior to the first dose of the study drug, or requires ongoing treatment with a medication that is a strong inhibitor or inducer of the cytochrome P450 3A4 (CYP3A4) enzymes.
15. Known sensitivity to any of the ingredients of the investigational product.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jing Wu
• Email: wujing@conjustar.com
• Phone: 086-21-33670866

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.