Advanced Solid TumorsBreast CancerNon Small Cell Lung Cancer
Investigational drug(s) / intervention(s)
YL202 for injection; Toripalimab injectionYL202 for injection; Furmonertinib Mesilate Tablets
YL202 for injection; Toripalimab injection: 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
YL202 for injection; Furmonertinib Mesilate Tablets: 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.
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF)
2. Able and willing to comply with protocol visits and procedures
3. Aged between 18 to 75 years
4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
5. Previously treated by standard treatment or have not been treated for metastatic setting;
6. Adequate organ and bone marrow function.
7. Have at least 1 extracranial measurable tumor lesion.
8. Adequate archival formalin-fixed paraffin embedded (FFPE) tissue from prior biopsy.
Exclusion Criteria:
1. With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates \[ADCs\]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).
2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
3. 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.
4. The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
5. 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.
6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
7. 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.
8. 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.
9. With meningeal metastasis or cancerous meningitis.
10. With brain metastasis or spinal cord compression.
11. Patients with uncontrolled or clinically significant cardiovascular diseases.
12. Clinically significant complicated pulmonary disorders.
13. Patients diagnosed with Gilbert syndrome.
14. Those with uncontrolled effusion in the third space requiring repeated drainage.
15. 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.
16. With serious infection before the first dose.
17. With known human immunodeficiency virus (HIV) infection.
18. With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
19. With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.
20. Unrelieved toxicity of previous anti-tumor therapy.
21. With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.
22. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.
23. With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance/alcohol abuse, in the opinion of the investigator.
Primary outcome measure(s)
Nature and frequency of dose-limiting toxicity (DLT) — 21 days after the first dose was administered to each subject. The purpose of DLT is to find maximum tolerated dose (MTD).
Nature and frequency of adverse events (AEs) — 42 days after the end of treatment (EOT). Nature and frequency of AEs with severity is aim to evaluate the safety of YL202 combination.
Trial sites (20)
Facility
City
Region
Status
Anhui Provincial Hospital(The First Affiliated Hospital of Ustc)
Hefei
Anhui
Not Yet Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Not Yet Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Not Yet Recruiting
Meizhou People's Hospital(Huangtang Hospital)Meizhou Academy of Medical Sciences
Meizhou
Guangdong
Not Yet Recruiting
Ghang xi Medical University Cancer Hospital
Nanning
Guangxi
Not Yet Recruiting
Affiliated Hospital Of Hebei University
Baoding
Hebei
Not Yet Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Not Yet Recruiting
Anyang Cancer Hospital
Anyang
Henan
Not Yet Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang
Henan
Not Yet Recruiting
Xiangyang Central Hospital
Xiangyang
Hubei
Not Yet Recruiting
The First People's Hospital of Changde City
Changde
Hunan
Not Yet Recruiting
Jiangsu Province Hospital(The First Affiliated Hospital With Nanjing Medical University, Jiangsu Women And Children Health Hospital)
Nanjing
Jiangsu
Not Yet Recruiting
Jiangxi Cancer Hospital
Nanchang
Jiangxi
Not Yet Recruiting
Affiliated Zhongshan Hospital Dalian University
Dalian
Liaoning
Not Yet Recruiting
Liaoning cancer hospital &institute
Shenyang
Liaoning
Not Yet Recruiting
Affiliated Zhongshan Hospital Dalian University
Jinan
Shandong
Not Yet Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Recruiting
Shanxi Cancer Hospital
Taiyuan
Shanxi
Not Yet Recruiting
Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital
Sichuan
Sichuan
Not Yet Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin
Tianjin Municipality
Not Yet Recruiting
More MediLink Therapeutics (Suzhou) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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