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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation | Experimental | All participants enrolled in the dose escalation part |
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| Dose expansion | Experimental | All participants enrolled in the dose expansion part |
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| Dose Selection | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL201 | Drug | Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline | Approximately within 36 months |
| Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 2, assessed using RECIST version 1.1 | ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR). | Approximately within 36 months |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the AEs in Part 1 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment | By the global end of trial date, approximately within 36 months | |
| Characterize the PK parameter AUC | Approximately within 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sasha Stann | Contact | 617-240-8494 | info@medilinkthera.com | |
| Alan Xu, Ph.D. | Contact | 617-871-9455 | info@medilinkthera.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 002 | Recruiting | Fair Oaks | California | 95628 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40082695 | Derived | Ma Y, Yang Y, Huang Y, Fang W, Xue J, Meng X, Fan Y, Fu S, Wu L, Zheng Y, Liu J, Liu Z, Zhuang W, Rosen S, Qu S, Li B, Li M, Zhao Y, Yang S, Ji Y, Sommerhalder D, Luo S, Yang K, Li J, Lv D, Zhang P, Zhao Y, Hong S, Zhang Y, Zhao S, Chin S, Zhang X, Lian W, Cai J, Xue T, Zhang L, Zhao H. A B7H3-targeting antibody-drug conjugate in advanced solid tumors: a phase 1/1b trial. Nat Med. 2025 Jun;31(6):1949-1957. doi: 10.1038/s41591-025-03600-2. Epub 2025 Mar 13. |
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| YL201 | Drug | Patients will be treated with YL201 intravenous (IV) (A mg/kg or B g/kg infusion once every 3 weeks (Q3W) as a cycle. |
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| YL201 and atezolizumab | Drug | 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 |
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| Characterize the PK parameter Cmax | Approximately within 36 months |
| Characterize the PK parameter Ctrough | Approximately within 36 months |
| Characterize the PK parameter CL | Approximately within 36 months |
| Characterize the PK parameter Vd | Approximately within 36 months |
| Characterize the PK parameter t1/2 | Approximately within 36 months |
| Assess the incidence of anti-YL201 antibodies | Approximately within 36 months |
| Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 1 | PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline | Approximately within 36 months |
| Evaluate the PSA progression-free survival (PSA-PFS) for patients with prostate cancer | PSA-PFS: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of PSA progression, based on PCWG3 criteria. | Approximately within 36 months |
| Evaluate the radiological PFS (rPFS) for patients with prostate cancer | rPFS: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of radiographic tumor progression or death due to any cause, whichever occurs first, based on RECIST 1.1 and PCWG3 criteria. | Approximately within 36 months |
| Evaluate the failure-free survival (FFS) for patients with prostate cancer | FFS: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of radiographic tumor progression, unequivocal clinical progression, PSA progression or death due to disease progression, whichever occurs first. | Approximately within 36 months |
| Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 1, Part 2, and Part 3, assessed using RECIST version 1.1 | ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR). | Approximately within 36 months |
| Evaluate the disease control rate (DCR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1 | DCR: defined as the proportion of patients who achieved a best overall response of CR, PR or stable disease (SD). | Approximately within 36 months |
| Evaluate the duration of response (DoR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1 | DoR: defined as the time interval from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of PD. DoR will be assessed for patients with a response (CR or PR) only. | Approximately within 36 months |
| Evaluate the time to response (TTR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1 | TTR: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of objective response (CR or PR). | Approximately within 36 months |
| Evaluate the progression-free survival (PFS) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1 | PFS: defined as the time interval from the date of the first dose of study drug to the date of first documentation of PD or death due to any cause, whichever occurs first. | Approximately within 36 months |
| Evaluate the overall survival (OS) for patients with solid tumors | OS: defined as the time interval from the date of the first dose of study drug to the date of death due to any cause. | Approximately within 36 months |
| 001 | Recruiting | La Jolla | California | 92093-0698 | United States |
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| 003 | Recruiting | Lone Tree | Colorado | 80124 | United States |
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| 004 | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
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| 005 | Recruiting | Boston | Massachusetts | 02114 | United States |
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| 006 | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| 007 | Recruiting | Detroit | Michigan | 48292 | United States |
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| 008 | Recruiting | St Louis | Missouri | 63110 | United States |
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| 009 | Recruiting | Santa Fe | New Mexico | 87505-699 | United States |
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| 010 | Recruiting | New York | New York | 10029 | United States |
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| 011 | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| 012 | Recruiting | Nashville | Tennessee | 37203 | United States |
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| 014 | Recruiting | Houston | Texas | 77030 | United States |
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| 015 | Recruiting | Irving | Texas | 75039 | United States |
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| 013 | Recruiting | San Antonio | Texas | 78229 | United States |
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| 016 | Recruiting | Tyler | Texas | 75701 | United States |
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| 017 | Recruiting | Fairfax | Virginia | 22031 | United States |
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| 018 | Recruiting | Spokane | Washington | 99208 | United States |
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| 019 | Recruiting | Tacoma | Washington | 98405 | United States |
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| 020 | Recruiting | Edmonton | Alberta | T6G 1Z2 | Canada |
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| 021 | Recruiting | Kelowna | British Columbia | V1Y 1E2 | Canada |
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| 022 | Recruiting | Brampton | Ontario | L6R 3J7 | Canada |
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| 023 | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
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| 024 | Completed | Guangzhou | Guangdong | 510000 | China |
| 025 | Completed | Zhengzhou | Henan | 450003 | China |
| 026 | Recruiting | Bordeaux | 33000 | France |
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| 027 | Recruiting | Dijon | 21000 | France |
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| 028 | Recruiting | Marseille | 13005 | France |
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| 029 | Not yet recruiting | Nantes | 44093 | France |
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| 030 | Not yet recruiting | Paris | 75248 | France |
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| 031 | Recruiting | Poitiers | 86021 | France |
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| 032 | Not yet recruiting | Saint-Herblain | 44800 | France |
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| 033 | Recruiting | Suresnes | 92150 | France |
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| 044 | Recruiting | Otwock | 05-400 | Poland |
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| 045 | Not yet recruiting | Poznan | 60-569 | Poland |
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| 034 | Recruiting | Barcelona | Barcelona | 08023 | Spain |
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| 035 | Recruiting | Barcelona | Barcelona | 08025 | Spain |
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| 039 | Not yet recruiting | Leganés | Madrid | 28911 | Spain |
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| 037 | Recruiting | Madrid | Madrid | 28034 | Spain |
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| 036 | Recruiting | Madrid | Madrid | 28050 | Spain |
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| 038 | Recruiting | Moncloa-Aravaca | Madrid | 28040 | Spain |
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| 041 | Recruiting | Pozuelo de Alarcón | Madrid | 28223 | Spain |
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| 042 | Recruiting | Usera | Madrid | 28041 | Spain |
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| 040 | Recruiting | Pamplona | Navarre | 31008 | Spain |
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| 043 | Recruiting | Valencia | Valencia | 46010 | Spain |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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