Recruiting
Phase 1
Phase 2

YL201 & Atezolizumab

Sponsor:

MediLink Therapeutics (Suzhou) Co., Ltd.

Code:

NCT07407933

Conditions

Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

YL201

Atezolizumab

Study Details

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.

Conditions

Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma

Study ID

NCT07407933

Start date

Mar 31, 2026

Status verified date

Jun, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W

experimental: YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W

experimental: YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W

Interventions

YL201

YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.

Atezolizumab

Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle

Primary outcome measure

  • Nature and Frequency with Dose-Limiting Toxicities (DLTs) [ Time Frame: 21 days ]
  • Adverse Events [ Time Frame: First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years) ]

Central Contacts and Locations

Central contacts

Locations

Site 1004

Recruiting

Louisville, Kentucky, United States, 40202

Site 1005

Recruiting

Houston, Texas, United States, 77030

Site 1002

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Small cell lung cancer, Antibody drug conjugate, YL201, atezolizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MediLink Therapeutics (Suzhou) Co., Ltd. on 2026-06-15.