YL201
DrugYL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.
NCT Number: NCT07407933
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Site 1201, Namur, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Other protocol-defined inclusion/ exclusion criteria may apply.
YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.
Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle
Time frame: 21 days
Time frame: First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)
Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5
Time frame: Up to approximately 3 years
Time frame: Up to approximately 3 years
Time frame: Up to approximately 3 years
Time frame: Up to approximately 3 years
Time frame: Up to approximately 3 years
Time frame: Up to approximately 3 years
Time frame: Up to approximately 3 years
Time frame: Up to approximately 3 years
Time frame: Up to approximately 3 years
Contact information is provided by the study sponsor or research team.
MediLink Therapeutics (Suzhou) Co., Ltd.
Industry
A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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