Evaluating SC-101 for advanced solid tumors

A Phase Ⅰ Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of SC-101 in Subjects With Advanced or Metastatic Solid Tumors That Express Nectin-4

This study is testing a new drug called SC-101 to see if it can safely help people with advanced solid tumors, including bladder cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tianjin ConjuStar Biologics Co., Ltd. (Industry-sponsored)
• Locations: 5 sites (Beijing, Beijing Municipality and 4 other locations)
• Trial ID: NCT06220838 on ClinicalTrials.gov

What this trial studies

This study is a first-in-human, multi-center, open-label trial assessing the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in patients with advanced or metastatic solid tumors. It includes a dose escalation phase to determine the recommended doses and a dose expansion phase focused on evaluating the clinical activity of SC-101 in patients with metastatic urothelial carcinoma or other solid tumors expressing Nectin-4. Participants will undergo monitoring for safety and treatment response throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with advanced malignant solid tumors that express Nectin-4.

Not a fit: Patients with non-malignant conditions or those whose tumors do not express Nectin-4 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: Other studies targeting Nectin-4 have shown promise, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

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).
9. Histologically or cytologically confirmed advanced malignant solid tumors.
10. 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.
11. Subjects are willing to follow study procedures.

Exclusion Criteria:

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.
9. Preexisting active keratitis or corneal ulcerations.
10. 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.).
11. 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.
12. History of uncontrolled diabetes mellitus.
13. 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.
14. Positive results of virus serology tests.
15. History of serious cardiovascular and cerebrovascular diseases, including but not limited to:

    1. Serious cardiac arrhythmias or conduction abnormalities, such as ventricular arrhythmia require treatment, and grade 2 or 3 atrioventricular block.
    2. QTc prolongation to \>450 milliseconds (ms) in males and \>470 ms in females based on ECG.
    3. 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.
    4. New myocardial infarction or unstable angina within 6 months before the first dose of the study drug.
    5. Uncontrolled hypertension.
16. Require ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome P450 3A4 (CYP3A4) enzymes.
17. Known sensitivity to any of the ingredients of the investigational product.

Where this trial is running

Beijing, Beijing Municipality and 4 other locations

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jing Wu

Conditions Advanced Solid Tumor