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: 220
• Locations: 2 countries
• Sites: 19

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 (3)

Part 2: The backfill stage of YL217

EXPERIMENTAL

Patients will be enrolled at one or more dose levels that do not exceed the dose that is deemed safe and tolerable in dose escalation. Then several dose levels will be selected as the recommended dose for expansion (RDE).

Drug: YL217

Part 1: Dose-Escalation Part

EXPERIMENTAL

Participants will receive escalating doses of YL217 until doses for optimization are determined

Drug: YL217

Part 3: Dose-Expansion Part

EXPERIMENTAL

Upon completion of Part 1 and Part 2 with determination of MTD/RDE(s), the dose-expansion part will be conducted to further support the RP2D selection.

Drug: YL217

Interventions

YL217 DRUG

Patients will be treated with YL217 intravenous(IV)infusion.

Part 1: Dose-Escalation Part

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
• Tumor types as below:
• For Part 1 and Part 2: Pathologically confirmed diagnosis of an advanced solid tumor.
• For Part 3 (Histologically or cytologically confirmed diagnosis+ locally advanced unresectable or metastatic disease)
• 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.
• 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, gastrointestinal obstruction.
• An active tuberculosis based on medical history.

Sponsors & Collaborators

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

Study Sites (19)

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

University of Maryland Medical Center-Greenebaum Cancer Ctr - Medical Oncology

Baltimore, Maryland, 21201, United States

NOT YET 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

NOT YET RECRUITING

Peking Union Medical College Hospital

Beijing, Bejing, 100730, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

NOT YET 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

NOT YET RECRUITING

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: SINGLE GROUP
• 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, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); CN (6)