NCT06710158 Study of SC-102 in Patients With Advanced Solid Tumors
| NCT ID | NCT06710158 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Tianjin ConjuStar Biologics Co., Ltd. |
| Condition | Advanced Solid Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 120 participants in total. It began in 2024-12-05 with a primary completion date of 2027-06-30.
⚠ 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, PK profile, and anti-cancer efficacy of SC-102 in subjects with advanced solid tumors
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06710158 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Solid Cancers. 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 NCT06710158 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 NCT06710158 currently recruiting?
Yes, NCT06710158 is actively recruiting participants. Contact the research team at wujing@conjustar.com for enrollment information.
Where is the NCT06710158 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06710158 clinical trial?
NCT06710158 is sponsored by Tianjin ConjuStar Biologics Co., Ltd.. The trial plans to enroll 120 participants.
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