A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

Conditions

• Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• YL201 — DRUG
  YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.
• Atezolizumab — DRUG
  Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle

Study Details

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.

Key Dates

Start date

Mar 31, 2026

Status verified

Apr 2026

Primary completion

Nov 30, 2028

Completion

Feb 28, 2029

Study Design

Enrollment

118 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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

Primary Outcome Measure

Nature and Frequency with Dose-Limiting Toxicities (DLTs) [ Time Frame: 21 days ]

Central Contacts

• MediLink Study Team
  86 0512-62858368
  [email protected]

Locations (3)

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