Setidegrasib

DRUG4 trials

Sponsors

Astellas Pharma Inc, Astellas Pharma Global Development, Inc.

Conditions

Healthy VolunteerMetastatic Pancreatic AdenocarcinomaMetastatic Pancreatic CancerNon-small Cell Lung Cancer (NSCLC)Pancreatic CancerSolid Tumor

Phase 1

A Study of ASP3082 in Adults With Advanced Solid Tumors

RecruitingNCT05382559

Astellas Pharma IncSolid Tumor

Start: 2022-06-08End: 2028-12-31Target: 681Updated: 2026-07-31

A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults

Active, not recruitingNCT07395024

Astellas Pharma Global Development, Inc.Healthy Volunteer

Start: 2026-02-03End: 2027-05-02Updated: 2026-08-27

Phase 3

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

RecruitingNCT07409272

Astellas Pharma Global Development, Inc.Metastatic Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer, Pancreatic Cancer

Start: 2026-02-17End: 2029-08-31Target: 614Updated: 2026-08-27

A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation

RecruitingNCT07566052

Astellas Pharma Global Development, Inc.Non-small Cell Lung Cancer (NSCLC)

Start: 2026-04-28End: 2030-06-30Target: 356Updated: 2026-09-17

Related Papers

Setidegrasib in Advanced Non-Small-Cell Lung Cancer and Pancreatic Cancer.

2026-03-25

Phase 1 evaluation of ASP3082, a first-in-class selective protein degrader, in patients (pts) with <i>KRAS G12D</i> -mutant pancreatic ductal adenocarcinoma (PDAC): Pharmacokinetics (PK) and biomarker insights.

Journal of Clinical Oncology2026-01-10

Efficacy and safety of ASP3082 monotherapy or in combination with mFOLFIRINOX in patients (pts) with pancreatic ductal adenocarcinoma (PDAC).

Journal of Clinical Oncology2026-01-10

Abstract A070: Optimal efficacious dose prediction of a novel protein degrader ASP3082 selectively targeting KRAS G12D using quantitative systems pharmacology

Molecular Cancer Therapeutics2025-10-22

Abstract 5735: Novel KRAS G12D degrader ASP3082 demonstrates in vivo, dose-dependent KRAS degradation, KRAS pathway inhibition, and antitumor efficacy in multiple KRAS G12D-mutated cancer models

Cancer Research2023-04-0417 citations

Trial in progress: A phase 1, first-in-human, open-label, multicenter, dose-escalation and dose-expansion study of ASP3082 in patients with previously treated advanced solid tumors and KRAS G12D mutations.

Journal of Clinical Oncology2023-01-2432 citations