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

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07407933

Enrollment

118

Registered

2026-02-12

Start date

2026-03-01

Completion date

2029-02-01

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma

Keywords

Small cell lung cancer, Antibody drug conjugate, YL201, atezolizumab

Brief summary

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

DRUGYL201

YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.

DRUGAtezolizumab

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame	Description
Nature and Frequency with Dose-Limiting Toxicities (DLTs)	21 days	—
Adverse Events	First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)	Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5

Secondary

Measure	Time frame
ORR	Up to approximately 3 years
DOR	Up to approximately 3 years
PFS	Up to approximately 3 years
OS	Up to approximately 3 years
AUC	Up to approximately 3 years
CL	Up to approximately 3 years
Vss	Up to approximately 3 years
t1/2	Up to approximately 3 years
Cmax	Up to approximately 3 years

Countries

United States

Contacts

CONTACTMediLink Study Team

clinicaltrials@medilinkthera.com+86 0512-62858368

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026