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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-20110 (Phase Ia:Dose escalation ) | Experimental |
| |
| HS-20110 (Phase 1b Dose expansion) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20110 (Phase Ia:Dose escalation ) | Drug | HS-20110 for IV infusion of various dose strengths administered in 21 day dosing cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) or maximum applicable dose (MAD) | From day 1 to one months after the last dose in Phase 1a | |
| Objective response rate (ORR) as per RECIST v1.1 | From screening to 2 months after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose modification or permanent discontinuation, and specific laboratory abnormalities | From the first dose until 90 days after the last dose | |
| Objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and progression-free survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
Participants have received or are receiving the following treatment:
Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior therapies (except alopecia and residual neurotoxicity).
Inadequate bone marrow reserve or hepatic and renal functions.
Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.
Participants who are allergic to any component of HS-20110.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongyan Wang | Contact | 15111915273 | wanghy10@hspharm.com | |
| Amanda Guo | Contact | guoj9@hspharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BRCR Medical Center INC | Recruiting | Tamarac | Florida | 33321 | United States |
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| HS-20110 (Phase Ib:Dose expansion ) | Drug | The recommended dose from the dose-escalation stage and other potential doses will be further explored |
|
| From screening to up to 3 years after last dose |
| Incidence of anti-HS-20110 antibody (ADA) | From the first dose until 90 days after the last dose |
| Drug concentrations of the three components of HS-20110 (including antibody-drug conjugates, total antibody, and payload) | From the first dose until 90 days after the last dose |
| Fort Wayne Medical Oncology and Hematology | Recruiting | Fort Wayne | Indiana | 46804 | United States |
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| Carolina BioOncology Institute | Recruiting | Huntersville | North Carolina | 28078 | United States |
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| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| NEXT Dallas | Recruiting | Irving | Texas | 75039 | United States |
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| NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
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| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
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| SUN YAT-SEN University Cancer Center | Recruiting | Guangzhou | Guangdong | 510000 | China |