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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W
  • Drug: YL201
    YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.
  • Drug: Atezolizumab
    Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle
Experimental
YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W
  • Drug: YL201
    YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.
  • Drug: Atezolizumab
    Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle
Experimental
YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W
  • Drug: YL201
    YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.
  • Drug: Atezolizumab
    Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle

Recruiting Locations

Site 1005
Houston, Texas 77030
Contact:
Study Coordinator

Site 1002
Fairfax, Virginia 22031
Contact:
Study Coordinator

More Details

Status
Recruiting
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.

Study Contact

MediLink Study Team
86 0512-62858368
clinicaltrials@medilinkthera.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.