YL201 + Atezolizumab for Small Cell Lung Cancer

Overseen By MediLink Study Team

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Disqualifiers: Brain metastases, Spinal cord compression, ILD, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Adults with a confirmed diagnosis of ES-SCLC who are in good physical condition and have proper organ function can join this trial. It's not for those who've had previous treatments for their lung cancer or have health issues that could interfere with the study.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1: Dose escalation to determine safety and tolerability of YL201 in combination with atezolizumab

Varies until dose determination

Dose Optimization

Part 2: Dose optimization stage where participants are randomized to receive different doses of YL201 with atezolizumab

Varies based on dose optimization

Dose Expansion

Continuation of treatment with selected dose(s) based on safety, PK, and efficacy review

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 6 years

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• YL201

Trial Overview

The trial is testing YL201 at different doses combined with Atezolizumab to find the safest and most effective amount. Participants will be randomly assigned to receive one of three YL201 dose levels along with Atezolizumab until they experience disease progression, side effects, or choose to leave the study.

How Is the Trial Designed?

Group I: YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W Experimental Treatment 2 Interventions

Group II: YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W Experimental Treatment 2 Interventions

Group III: YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

MediLink Therapeutics (Suzhou) Co., Ltd.

Lead Sponsor

Trials

12

Recruited

3,400+

Hoffmann-La Roche

Industry Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD