NCT07407933 A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
| NCT ID | NCT07407933 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | MediLink Therapeutics (Suzhou) Co., Ltd. |
| Condition | Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2028-11 |
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 118 participants in total. It began in 2026-03-31 with a primary completion date of 2028-11.
⚠ 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 is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.
Eligibility Criteria
Inclusion Criteria: 1.18 years of age or older. 2. Histologically or cytologically confirmed diagnosis of ES-SCLC 3. Eastern Cooperative Oncology Group performance status of 0 or 1 4. Adequate hematologic and end-organ function Exclusion Criteria: 1. No prior systemic anti-cancer treatment for ES-SCLC 2. No prior treatment targeting B7H3 or topoisomerase I inhibitor 3. No clinically active brain metastases or spinal cord compression 4. No current or history of interstitial lung disease (ILD)/ pneumonitis 5. No clinically significant cardiovascular disease (eg, New York Heart Association class II to IV congestive heart failure) Other protocol-defined inclusion/ exclusion criteria may apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07407933 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma. 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 NCT07407933 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 NCT07407933 currently recruiting?
Yes, NCT07407933 is actively recruiting participants. Contact the research team at clinicaltrials@medilinkthera.com for enrollment information.
Where is the NCT07407933 trial being conducted?
This trial is being conducted at Washington D.C., United States, Louisville, United States, Houston, United States, Fairfax, United States and 11 additional locations.
Who is sponsoring the NCT07407933 clinical trial?
NCT07407933 is sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.. The trial plans to enroll 118 participants.