A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors

NCT06859762 | Recruiting Phase 1 FDA Drug

• 1 other identifier: YL217-INT-101-01
• Study Type: interventional
• Target: 630
• Locations: 2 countries
• Sites: 21

Brief Summary

A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Nature and frequency of dose-limiting toxicity(DLT)

  The purpose of DLT is to find maximum tolerated dose (MTD).

  Up to approximately 3 years

• Nature and frequency of adverse events (AEs) with severity

  Nature and frequency of AEs with severity is aim to evaluate the safety of YL217.

  Up to approximately 3 years

• objective response rate (ORR)

  ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).

  Up to approximately 3 years

Secondary Outcomes (16)

• Eastern Cooperative Oncology Group performance status (ECOG PS)

  Up to approximately 3 years

• To evaluate safety endpoint of peripheral oxygen saturation (SpO2)

  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

Study Arms (2)

Combo-Dose Escalation,Backfill and Expansion

EXPERIMENTAL

Participants will receive YL217 in combination of bevacizumab with or without 5-FU/LV

Drug: YL217; Drug: Bevacizumab; Drug: 5-FU with leucovorin

Mono-Dose Escalation,Backfill and Expansion

EXPERIMENTAL

Participants will receive YL217 monotherapy

Drug: YL217

Interventions

YL217 DRUG

Patients will receive specific dose of YL217 administered via intravenous(IV)infusion.

Combo-Dose Escalation,Backfill and Expansion; Mono-Dose Escalation,Backfill and Expansion

Bevacizumab DRUG

Participants will receive bevacizumab administered via intravenous(IV) infusion,at 5mg/kg,Q2W.

Combo-Dose Escalation,Backfill and Expansion

5-FU with leucovorin DRUG

Participants will receive 5 fluorouracil 2400mg/m2 and leucovorin 400mg/m2, administered via intravenous (IV) infusion, Q2W

Combo-Dose Escalation,Backfill and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (21)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, 90404, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06519, United States

RECRUITING

The University of Kansas Cancer Center (KUCC)

Kansas City, Kansas, 66205, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Duke University Medical Center (DUMC)

Durham, North Carolina, 27710, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

UT Health San Antonio - Mays Cancer Center

San Antonio, Texas, 78229, United States

RECRUITING

University of Wisconsin Health - UW Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

Peking Union Medical College Hospital

Beijing, Bejing, 100730, China

RECRUITING

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

NOT YET RECRUITING

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab; Fluorouracil; Leucovorin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Central Study Contacts

Angie Cao, MD

CONTACT

+86 0512-62858368; clinicaltrials@medilinkthera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Phase 1, Multicenter, Open-Label, First-in-Human Study

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 5, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); CN (9)