YL201 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas MD Anderson Cancer Center, Houston, TX
Solid Tumors, Advanced Solid Tumors+1 More
YL201 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201 conducted in China and the United States. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2). Part 1 will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available. Part 2 will include patients with selected advanced solid tumor types enrolled at the MTD/RED(s), to better define the safety profile and evaluate the efficacy of YL201.

Eligible Conditions

  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Study Objectives

4 Primary · 18 Secondary · Reporting Duration: Approximately within 36 months

Day 21
Evaluate the occurrence of DLTs during the first cycle in Part 1
Approximately within 36 months
Assess the incidence of anti-YL201 antibodies
Characterize the PK parameter AUC
Characterize the PK parameter CL
Characterize the PK parameter Cmax
Characterize the PK parameter Ctrough
Characterize the PK parameter Vd
Characterize the PK parameter t1/2
Evaluate the PSA progression-free survival (PSA-PFS) for patients with prostate cancer
Evaluate the disease control rate (DCR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1
Evaluate the duration of response (DoR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1
Evaluate the failure-free survival (FFS) for patients with prostate cancer
Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 1, assessed using RECIST version 1.1
Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 2, assessed using RECIST version 1.1
Evaluate the overall survival (OS) for patients with solid tumors
Evaluate the progression-free survival (PFS) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1
Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 1
Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 2
Evaluate the radiological PFS (rPFS) for patients with prostate cancer
Evaluate the time to response (TTR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1
Month 36
Evaluate the AEs in Part 1 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment
Evaluate the AEs in Part 2 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Trial Design

2 Treatment Groups

Dose escalation
1 of 2
Dose expansion
1 of 2
Experimental Treatment

196 Total Participants · 2 Treatment Groups

Primary Treatment: YL201 · No Placebo Group · Phase 1

Dose escalation
Drug
Experimental Group · 1 Intervention: YL201 · Intervention Types: Drug
Dose expansion
Drug
Experimental Group · 1 Intervention: YL201 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately within 36 months
Closest Location: The University of Texas MD Anderson Cancer Center · Houston, TX
Photo of the university of texas md anderson cancer center 1Photo of the university of texas md anderson cancer center 2Photo of the university of texas md anderson cancer center 3
2006First Recorded Clinical Trial
23 TrialsResearching Solid Tumors, Advanced Solid Tumors
152 CompletedClinical Trials

Who is running the clinical trial?

MediLink Therapeutics (Suzhou) Co., Ltd.Lead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The additional inclusion criteria for part 1 are met.
You have an advanced solid tumor for which prior standard treatment had proven to be ineffective or intolerable, or no standard treatment is available.
You are aged at least 18 years.
You have a performance status of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.