A Study of YL201 in Patients With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
YL201: Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle.
YL201: Patients will be treated with YL201 intravenous (IV) (A mg/kg or B g/kg infusion once every 3 weeks (Q3W) as a cycle.
YL201 and atezolizumab: Patients will be treated with YL201 intravenous (IV) infusion (A mg/kg or B mg/kg, up to 200mg) followed by atezolizumab on day 1 of each 21 day cycle
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.
Eligibility
Primary outcome measure(s)
- Evaluate the occurrence of DLTs during the first cycle in Part 1 — 21 days of Cycle 1
- Evaluate the AEs in Part 2 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment — By the global end of trial date, approximately within 36 months
- Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 2 — Approximately within 36 months
PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline - Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 2, assessed using RECIST version 1.1 — Approximately within 36 months
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR). - Laboratory abnormalities as characterized by type, frequency, severity, and timing in Part 2 — Biy the end of trial date, approximately within 36 months
- Incidence, nature, and severity of AEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V5.0 in Part 3 — Biy the end of trial date, approximately within 36 months
- Nature and frequency of dose-limiting toxicities (DLTs), incidence, nature, and severity of laboratory abnormalities in Part 3 — At the end of cycle 1 (each cycle is 21 days)
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| 002 | Fair Oaks | California | Recruiting |
| 001 | La Jolla | California | Recruiting |
| 003 | Lone Tree | Colorado | Recruiting |
| 004 | Washington D.C. | District of Columbia | Recruiting |
| 005 | Boston | Massachusetts | Recruiting |
| 006 | Ann Arbor | Michigan | Recruiting |
| 007 | Detroit | Michigan | Recruiting |
| 008 | St Louis | Missouri | Recruiting |
| 009 | Santa Fe | New Mexico | Recruiting |
| 010 | New York | New York | Recruiting |
| 011 | Chapel Hill | North Carolina | Recruiting |
| 012 | Nashville | Tennessee | Recruiting |
| 014 | Houston | Texas | Recruiting |
| 015 | Irving | Texas | Recruiting |
| 013 | San Antonio | Texas | Recruiting |
| 016 | Tyler | Texas | Recruiting |
| 017 | Fairfax | Virginia | Recruiting |
| 018 | Spokane | Washington | Recruiting |
| 019 | Tacoma | Washington | Recruiting |
| 020 | Edmonton | Alberta | Recruiting |
| 021 | Kelowna | British Columbia | Recruiting |
| 022 | Brampton | Ontario | Recruiting |
| 023 | Toronto | Ontario | Recruiting |
| 024 | Guangzhou | Guangdong | Completed |
| 025 | Zhengzhou | Henan | Completed |
| 026 | Bordeaux | France | Recruiting |
| 027 | Dijon | France | Recruiting |
| 028 | Marseille | France | Recruiting |
| 029 | Nantes | France | Not Yet Recruiting |
| 030 | Paris | France | Not Yet Recruiting |
| 031 | Poitiers | France | Recruiting |
| 032 | Saint-Herblain | France | Not Yet Recruiting |
| 033 | Suresnes | France | Recruiting |
| 044 | Otwock | Poland | Recruiting |
| 045 | Poznan | Poland | Not Yet Recruiting |
| 034 | Barcelona | Barcelona | Recruiting |
| 035 | Barcelona | Barcelona | Recruiting |
| 039 | Leganés | Madrid | Not Yet Recruiting |
| 037 | Madrid | Madrid | Recruiting |
| 036 | Madrid | Madrid | Recruiting |
+ 5 more sites — see the full list on the official registry below.
More MediLink Therapeutics (Suzhou) Co., Ltd. trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05434234 on ClinicalTrials.gov ↗ ← All trials in Spain