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Monoclonal Antibodies

YL211 for Cancer

Phase 1
Recruiting
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
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
History of an advanced solid tumors who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit
Must not have
Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases
Clinically significant concomitant pulmonary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately within 36 months
Awards & highlights

Summary

This trial is testing a new drug, YL211, on patients with advanced solid tumors. It consists of three parts: dose escalation, backfill enrollment, and dose expansion. The goal is to

Who is the study for?
This trial is for individuals with advanced solid tumors who have likely tried other treatments without success. Specific details about eligibility criteria are not provided, but typically participants must be adults in stable condition and able to comply with study requirements.Check my eligibility
What is being tested?
YL211 is being tested in this Phase I trial. It's given intravenously to patients with advanced solid tumors across three parts: dose-escalation to find the maximum tolerated dose (MTD), backfill enrollment to confirm safety and efficacy, and dose-expansion at MTD to further assess its effects.See study design
What are the potential side effects?
As YL211 is a new treatment under investigation, specific side effects are not listed here. Generally, such drugs can cause reactions at the infusion site, fatigue, nausea, or more serious conditions depending on how they work against cancer cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My advanced cancer has not responded to standard treatments and cannot be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have uncontrolled heart or brain blood vessel problems.
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I have a serious lung condition besides my cancer.
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I do not have an infection needing treatment in the last 2 weeks.
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I still have side effects from past cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately within 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately within 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ORR assessed using RECIST version 1.1
To determine the MTD and select the recommended expansion dose(s) (RED(s)) of YL211 in patients with advanced solid tumors
To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0
+1 more
Secondary outcome measures
To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
To characterize the CL of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
+12 more
Other outcome measures
Characterization of genomic alterations that are predictive of response to YL211
The use of circulating tumor DNA (ctDNA) to monitor response to YL211 treatment

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3: Dose-Expansion PartExperimental Treatment1 Intervention
Dose-Expansion Part
Group II: Part 2: Backfill Enrollment PartExperimental Treatment1 Intervention
Backfill Enrollment Part
Group III: Part 1: Dose-Escalation PartExperimental Treatment1 Intervention
Dose-Escalation Part

Find a Location

Who is running the clinical trial?

MediLink Therapeutics (Suzhou) Co., Ltd.Lead Sponsor
8 Previous Clinical Trials
1,810 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,436 Previous Clinical Trials
1,091,480 Total Patients Enrolled
~103 spots leftby Apr 2027