A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors
A Multi-center, Open-Label, Phase Ib/II Study of YL202 in Combination With Anti-tumor Therapy to Evaluate the Safety, Tolerability, and Efficacy in Patients With Advanced Solid Tumors
1 other identifier
interventional
414
1 country
20
Brief Summary
This is a multicenter, open-label, phase Ib/II study of YL202 in combination with other anti-tumor therapies to Evaluate the Safety, Tolerability, and Efficacy in Patients with Advanced Solid Tumors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2025
Typical duration for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2025
CompletedFirst Submitted
Initial submission to the registry
September 3, 2025
CompletedFirst Posted
Study publicly available on registry
September 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
September 12, 2025
September 1, 2025
12 months
September 3, 2025
September 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Nature and frequency of dose-limiting toxicity (DLT)
The purpose of DLT is to find maximum tolerated dose (MTD).
21 days after the first dose was administered to each subject.
Nature and frequency of adverse events (AEs)
Nature and frequency of AEs with severity is aim to evaluate the safety of YL202 combination.
42 days after the end of treatment (EOT).
Secondary Outcomes (9)
Objective response rate (ORR)
Up to approximately 3 years.
Characterize Pharmacokinetics (PK) parameter AUC
Up to approximately 3 years
Characterize Pharmacokinetics (PK) parameter Cmax
Up to approximately 3 years
Characterize Pharmacokinetics (PK) parameter Ctrough
Up to approximately 3 years
Characterize Pharmacokinetics (PK) parameter Tmax
Up to approximately 3 years
- +4 more secondary outcomes
Study Arms (2)
YL202 in combination with Toripalimab
EXPERIMENTALPart 1 (dose escalation stage and backfill stage) \& Part 3 (dose expansion stage): YL202 for injection in combination with Toripalimab injection
YL202 in combination with Furmonertinib Mesilate
EXPERIMENTALPart 2 (dose escalation stage and backfill stage) \& Part 4 (dose expansion stage): YL202 for injection in combination with Furmonertinib Mesilate Tablets
Interventions
Part 1: YL202 and Toripalimab will be administered intravenously. Part 3: participants will receive escalating doses of YL202 and fixed dose of Toripalimab until YL202 doses for optimization are determined. Dose expansion stage: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Toripalimab
Part 2: YL202 will be administered intravenously，Furmonertinib Mesilate Tablets will be administered orally. Dose escalation stage: participants will receive escalating doses of YL202 and fixed dose of Furmonertinib Mesilate until YL202 doses for optimization are determined. Part 4: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Furmonertinib Mesilate.
Eligibility Criteria
You may qualify if:
- Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF)
- Able and willing to comply with protocol visits and procedures
- Aged between 18 to 75 years
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Previously treated by standard treatment or have not been treated for metastatic setting;
- Adequate organ and bone marrow function.
- Have at least 1 extracranial measurable tumor lesion.
- Adequate archival formalin-fixed paraffin embedded （FFPE） tissue from prior biopsy.
You may not qualify if:
- With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates \[ADCs\]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).
- Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
- Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.
- The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
- Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study.
- Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
- Prior treatment with systemic steroids (prednisone \> 10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product.
- Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period.
- With meningeal metastasis or cancerous meningitis.
- With brain metastasis or spinal cord compression.
- Patients with uncontrolled or clinically significant cardiovascular diseases.
- Clinically significant complicated pulmonary disorders.
- Patients diagnosed with Gilbert syndrome.
- Those with uncontrolled effusion in the third space requiring repeated drainage.
- With a medical history of gastrointestinal perforation and/or fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Anhui Provincial Hospital(The First Affiliated Hospital of Ustc)
Hefei, Anhui, 230001, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510555, China
Meizhou People's Hospital（Huangtang Hospital）Meizhou Academy of Medical Sciences
Meizhou, Guangdong, 514031, China
Ghang xi Medical University Cancer Hospital
Nanning, Guangxi, 530028, China
Affiliated Hospital Of Hebei University
Baoding, Hebei, 71051, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Anyang Cancer Hospital
Anyang, Henan, 455100, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471023, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441138, China
The First People's Hospital of Changde City
Changde, Hunan, 415000, China
Jiangsu Province Hospital（The First Affiliated Hospital With Nanjing Medical University, Jiangsu Women And Children Health Hospital)
Nanjing, Jiangsu, 210029, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Affiliated Zhongshan Hospital Dalian University
Dalian, Liaoning, 116001, China
Liaoning cancer hospital &institute
Shenyang, Liaoning, 110042, China
Affiliated Zhongshan Hospital Dalian University
Jinan, Shandong, 250117, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 30013, China
Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital
Sichuan, Sichuan, 610072, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300300, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2025
First Posted
September 12, 2025
Study Start
September 2, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
November 30, 2027
Last Updated
September 12, 2025
Record last verified: 2025-09