YL217: Patients will receive specific dose of YL217 administered via intravenous(IV)infusion.
Bevacizumab: Participants will receive bevacizumab administered via intravenous(IV) infusion,at 5mg/kg,Q2W.
5-FU with leucovorin: Participants will receive 5 fluorouracil 2400mg/m2 and leucovorin 400mg/m2, administered via intravenous (IV) infusion, Q2W
Study summary
A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Informed of the study before the start of the study and voluntarily sign their name and date in the ICF
* Able and willing to comply with protocol visits and procedures
* Age≥ 18 years
* ECOG PS of 0 or 1
* Pathologically confirmed diagnosis of an advanced solid tumor. For CRC cohorts: : Histologically or cytologically documented locally advanced unresectable or metastatic colorectal carcinoma that is not eligible for curative surgery and/or definitive chemoradiotherapy
* 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.
Exclusion Criteria:
* Prior treatment with an agent targeting CDH17
* Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities.
* Have received an ADC consisting of a topoisomerase I inhibitor.
* Concurrent enrollment in another clinical study, unless it is an observational clinical study.
* Inadequate washout period for prior anticancer treatment before the first dose of study drug
* Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study, minor procedures (e.g., core needle biopsy, superficial biopsy) within 7 days before the first dose of study drug.
* Received long term systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.
* Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.
* Diagnosis or evidence of spinal cord compression or leptomeningeal carcinomatosis.
* Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
* A history of non-infectious interstitial lung disease (ILD)/pneumonitis that requires steroids, current active ILD/pneumonitis.
* Have clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
* Uncontrolled third-space fluid that requires repeated drainage.
* Digestive system disease that may cause bleeding, perforation, jaundice, fistula, GI obstruction within 6 months prior to the first dose of study drug administration or have active inflammatory bowel disease.
* An active tuberculosis based on medical history.
* Known human immunodeficiency virus (HIV) infection.
* Active hepatitis C infection.
Primary outcome measure(s)
Nature and frequency of dose-limiting toxicity(DLT) — Up to approximately 3 years The purpose of DLT is to find maximum tolerated dose (MTD).
Nature and frequency of adverse events (AEs) with severity — Up to approximately 3 years Nature and frequency of AEs with severity is aim to evaluate the safety of YL217.
objective response rate (ORR) — Up to approximately 3 years ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
Trial sites (21)
Facility
City
Region
Status
Mayo Clinic Arizona
Phoenix
Arizona
Recruiting
UCLA Hematology/Oncology - Santa Monica
Santa Monica
California
Recruiting
Yale Cancer Center
New Haven
Connecticut
Recruiting
The University of Kansas Cancer Center (KUCC)
Kansas City
Kansas
Recruiting
Karmanos Cancer Institute
Detroit
Michigan
Recruiting
Columbia University Irving Medical Center
New York
New York
Recruiting
Duke University Medical Center (DUMC)
Durham
North Carolina
Recruiting
University of Cincinnati Medical Center
Cincinnati
Ohio
Recruiting
Cleveland Clinic Taussig Cancer Institute
Cleveland
Ohio
Recruiting
The University of Texas MD Anderson Cancer Center
Houston
Texas
Recruiting
UT Health San Antonio - Mays Cancer Center
San Antonio
Texas
Recruiting
University of Wisconsin Health - UW Carbone Cancer Center
Madison
Wisconsin
Recruiting
Peking Union Medical College Hospital
Beijing
Bejing
Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou
Guangdong
Not Yet Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Not Yet Recruiting
The First Affiliated Hospital of China Medical University
Shenyang
Liaoning
Not Yet Recruiting
Cancer Hospital of Shandong First Medical University
Jinan
Shandong
Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Shanghai Municipality
Recruiting
Tianjin Medical University Cancer Institute & Hospital
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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