A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: YL201, Atezolizumab.
- Who it may be relevant to
- Registry conditions: Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Italy, Poland, Romania +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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
Primary outcome measures
- 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)]
Secondary outcome measures (9)
- ORR [Time frame: Up to approximately 3 years]
- DOR [Time frame: Up to approximately 3 years]
- PFS [Time frame: Up to approximately 3 years]
- OS [Time frame: Up to approximately 3 years]
- AUC [Time frame: Up to approximately 3 years]
- CL [Time frame: Up to approximately 3 years]
- Vss [Time frame: Up to approximately 3 years]
- t1/2 [Time frame: Up to approximately 3 years]
- Cmax [Time frame: Up to approximately 3 years]
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
- No prior systemic anti-cancer treatment for ES-SCLC
- No prior treatment targeting B7H3 or topoisomerase I inhibitor
- No clinically active brain metastases or spinal cord compression
- No current or history of interstitial lung disease (ILD)/ pneumonitis
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 10 centers
- Site 2013 — Badajoz
- Site 2014 — Barcelona
- Site 2003 — Barcelona
- Site 2002 — Madrid
- Site 2005 — Madrid
- Site 2004 — Madrid
- Site 2011 — Madrid
- Site 2010 — Manresa
- … and 2 more centers
United States · 4 centers
- Site 1001 — Washington D.C.
- Site 1004 — Louisville
- Site 1005 — Houston
- Site 1002 — Fairfax
Poland · 3 centers
- Site 1802 — Otwock
- Site 1804 — Poznan
- Site 1801 — Przemyśl
Italy · 2 centers
- Site 1703 — Meldola
- Site 1702 — Ravenna
Belgium · 1 center
- Site 1201 — Namur
Romania · 1 center
- Site 1901 — Craiova
United Kingdom · 1 center
- Site 2201 — London
Identifiers
NCT: NCT07407933 · YL201-INT-102-02