NCT06220838 Study SC-101 in Subjects With Advanced Malignancies
| NCT ID | NCT06220838 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Tianjin ConjuStar Biologics Co., Ltd. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-02 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-02-02 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the safety, pharmacokinetics, and anti-cancer efficacy of SC-101 in subjects with advanced or metastatic solid tumors.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06220838 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06220838 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06220838 currently recruiting?
Yes, NCT06220838 is actively recruiting participants. Contact the research team at wujing@conjustar.com for enrollment information.
Where is the NCT06220838 trial being conducted?
This trial is being conducted at Beijing, China, Changsha, China, Nanjing, China, Shanghai, China and 1 additional location.
Who is sponsoring the NCT06220838 clinical trial?
NCT06220838 is sponsored by Tianjin ConjuStar Biologics Co., Ltd.. The trial plans to enroll 100 participants.