Evaluating SC-102 for advanced solid tumors

Phase Ⅰ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of SC-102 in Subjects With Advanced or Metastatic Solid Tumors That Express EphA2

This study is testing a new drug called SC-102 to see if it can safely help people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin ConjuStar Biologics Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06710158 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced solid tumors who have not responded to standard therapies.

Not a fit: Patients with non-malignant conditions or those who have not exhausted all appropriate treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors who have exhausted existing treatments.

How similar studies have performed: While this approach is novel, similar studies involving peptide drug conjugates have shown promise in treating various cancers.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jing Wu

Conditions Advanced Solid Cancers