NCT03799003

A Study of ASP1951 in Subjects With Advanced Solid Tumors

Terminated Phase 1 Last updated 1 November 2024

What this trial tests

Phase 1 trial testing ASP1951 in Advanced Solid Tumors in 119 participants. Terminated before completion.

Timeline

14 January 2019

Primary endpoint
6 July 2023

6 July 2023

Quick facts

Lead sponsor	Astellas Pharma Global Development, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	119
Start date	14 January 2019
Primary completion	6 July 2023
Estimated completion	6 July 2023
Sites	32 locations across Taiwan, Canada, United States, South Korea

Drugs / interventions tested

• ASP1951 — full drug profile →
• pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Advanced Solid Tumors — all drugs for Advanced Solid Tumors →

Sponsor

Astellas Pharma Global Development, Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to evaluate the tolerability and safety profile of ASP1951 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1951 when administered as a single agent and in combination with pembrolizumab; and determine the recommended phase 2 dose (RP2D) of ASP1951 and/or maximum tolerated dose (MTD) when administered as a single agent and in combination with pembrolizumab. This study will also evaluate the anti-tumor effect of ASP1951 when administered as a single agent and in combination with pembrolizumab.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
   Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
2. Cervical Cancer Immunotherapy: Facts and Hopes.
   Ferrall L, Lin KY, Roden RBS, Hung CF, et al · · 2021 · cited 255× · PMID 33888488 · DOI 10.1158/1078-0432.ccr-20-2833
3. T-cell agonists in cancer immunotherapy.
   Choi Y, Shi Y, Haymaker CL, Naing A, et al · · 2020 · cited 90× · PMID 33020242 · DOI 10.1136/jitc-2020-000966
4. New emerging targets in cancer immunotherapy: the role of GITR.
   Buzzatti G, Dellepiane C, Del Mastro L. · · 2020 · cited 53× · PMID 32817129 · DOI 10.1136/esmoopen-2020-000738
5. Immune deserts in head and neck squamous cell carcinoma: A review of challenges and opportunities for modulating the tumor immune microenvironment.
   Farlow JL, Brenner JC, Lei YL, Chinn SB. · · 2021 · cited 34× · PMID 34218062 · DOI 10.1016/j.oraloncology.2021.105420
6. Immune checkpoint inhibitors in cervical cancer: Current status and research progress.
   Xie Y, Kong W, Zhao X, Zhang H, et al · · 2022 · cited 28× · PMID 36387196 · DOI 10.3389/fonc.2022.984896
7. Human papillomavirus associated cervical lesion: pathogenesis and therapeutic interventions.
   Ye J, Zheng L, He Y, Qi X. · · 2023 · cited 27× · PMID 37719443 · DOI 10.1002/mco2.368
8. Targeting Co-Stimulatory Receptors of the TNF Superfamily for Cancer Immunotherapy.
   Müller D. · · 2023 · cited 24× · PMID 36571696 · DOI 10.1007/s40259-022-00573-3