RightFit
RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests YL201 with atezolizumab, another cancer drug, in adults with small cell lung cancer that has spread widely and has not been treated. It aims to find a safe dose of YL201 and learn how well the drug combination works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • A tissue or cell test shows small cell lung cancer that has spread widely.
  • You can do all usual activities, or have trouble only with hard physical activity.
  • Your blood counts and major organs work well enough for the study.

Who can't join

  • You have had cancer treatment that travels through the body for this widely spread lung cancer.
  • You have had a drug that targets B7H3 or blocks topoisomerase I.
  • You have active cancer spread to the brain or pressure on the spinal cord.
  • You have or have had lung inflammation called interstitial lung disease or pneumonitis.
  • You have serious heart or blood vessel disease, such as certain levels of heart failure.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (5)

DC

FL

KY

TX

VA