A First-in-Human Study of YL217 in Patients With Advanced... | NCT06859762

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
YL217	Drug	Patients will be treated with YL217 intravenous(IV)infusion.	Part 1: Dose-Escalation Part

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Eastern Cooperative Oncology Group performance status (ECOG PS)	Deterioration of Eastern Cooperative Oncology Group performance status (ECOG PS)	Up to approximately 3 years
To evaluate safety endpoint of peripheral oxygen saturation (SpO2)

Eligibility Module

Eligibility Criteria

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
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.

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.
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.
Known human immunodeficiency virus (HIV) infection.
Active hepatitis C infection.