A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT03260322. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of this study is to evaluate the tolerability and safety profile of ASP8374 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumor malignancies. Also primary purpose is to characterize the pharmacokinetic profile of ASP8374 when administered as a single agent and in combination with pembrolizumab. Last primary purpose of this study is to determine the recommended Phase 2 dose (RP2D) of ASP8374 when administered as a single agent and in combination with pembrolizumab. The secondary purpose of this study is to evaluate the anti-tumor effect (objective response rate \[ORR\], duration of response \[DOR\], persistence of response after discontinuation, and disease control rate \[DCR\]) of ASP8374 when administered as a single agent and in combination with pembrolizumab. NTP: Neutropenia NHAE:Non-haematological AE GBS: Guillain-Barré syndrome"" IRR: Infusion-related reaction AST: Aspartate aminotransferase ALT: Alanine aminotransferase MS/MG: Myasthenia Syndrome/Myasthenia Gravis TRT: Treatment-related Toxicity TCP: Thrombocytopenia
Study identification
- NCT ID
- NCT03260322
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 169 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 7, 2017
- Primary completion
- May 9, 2022
- Completion
- May 9, 2022
- Last update posted
- Apr 23, 2025
2017 – 2022
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Honor Health Research Institute | Scottsdale | Arizona | 85258 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| University of California, Davis | Sacramento | California | 95817 | — |
| University of California, San Francisco | San Francisco | California | 94115 | — |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Cancer Center | Fairway | Kansas | 66205 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University Hospital of Cleveland | Cleveland | Ohio | 44106 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Mary Crowley Research Center | Dallas | Texas | 75251 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226-3522 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03260322, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2025 · Synced Sep 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03260322 live on ClinicalTrials.gov.