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Monoclonal Antibodies

YL217 for Cancer

San Antonio, TX

Phase 1

Waitlist Available

Research Sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged ≥ 18 years

Histologically or cytologically confirmed diagnosis+ locally advanced unresectable or metastatic disease

Must not have

Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study

Diagnosis or evidence of spinal cord compression or leptomeningeal carcinomatosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is the first time YL217 is being tested in humans with advanced solid tumors.

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Who is the study for?

Adults aged 18+ with advanced solid tumors, including certain gastrointestinal cancers, who can sign consent and follow study procedures. They must have at least one measurable tumor lesion, good organ function, and an ECOG performance status of 0 or 1. Those with HIV, recent major surgery, severe lung issues or specific prior treatments are excluded.Check my eligibility

What is being tested?

The trial is testing YL217, a new drug given as an intravenous infusion every three weeks to patients with various advanced solid tumors. It's the first time this drug is being tested in humans to see how safe it is and how well it works.See study design

What are the potential side effects?

As this is a first-in-human study for YL217, potential side effects are not yet fully known but may include typical reactions related to IV infusions such as pain at the injection site or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is advanced and cannot be removed by surgery.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have at least one tumor outside the brain that can be measured.

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I have a confirmed advanced solid tumor in my GI tract or related areas.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 4 weeks and do not expect any during the study.

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I have spinal cord compression or cancer spread to the lining of my brain.

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I have active tuberculosis.

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I am HIV positive.

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I stopped a specific cancer treatment due to side effects.

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I haven't taken steroids or immunosuppressants in the last 2 weeks.

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I haven't had a live vaccine in the last 4 weeks and won't get one during the study.

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I have severe lung problems due to another lung illness.

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I have been treated with a drug targeting CDH17 before.

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I have been treated with a specific type of chemotherapy.

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I haven't waited long enough after my last cancer treatment to start a new one.

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I do not have serious heart or brain blood vessel problems.

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I have or had lung inflammation not caused by infection, treated with steroids.

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I need frequent procedures to remove excess body fluids.

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I have a digestive condition that could lead to bleeding or blockage.

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I have an active hepatitis C infection.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nature and frequency of adverse events (AEs) with severity

Nature and frequency of dose-limiting toxicity(DLT)

objective response rate (ORR)

Secondary study objectives

Characterize Pharmacokinetics(PK) parameter AUC

Characterize Pharmacokinetics(PK) parameter CL

Characterize Pharmacokinetics(PK) parameter Cmax

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: The dose escalation stage, backfill stage and dose expansion stage of YL217Experimental Treatment1 Intervention

Part 1: The dose escalation stage：A preliminary anticipated dose-escalation sequence is 0.5, 1.0, 2.0, 3.0, and 4.0 mg/kg. Part 2: Backfill stage：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 at least two dose levels will be selected as the recommended dose for expansion (RDE). Part 3: The dose expansion stage：Dose optimization will be performed in at least one of disease-specific cohorts where patients will be randomly assigned to two dose regimens in a 1:1 ratio.

0 / 21Eligibility criteria met