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Clinical trial · no report yet · Phase 1

NCT05382559

A Study of ASP3082 in Adults With Advanced Solid Tumors

  • NCT05382559 ↗
  • Recruiting
  • Astellas Pharma Inc
  • 3 commentary sources found
  • Focused

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built. Commentary is thin so far, so the report would be short.

ChannelFound
X threads3

The trial

ClinicalTrials.gov
Official title
A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation
Phase
Phase 1
Status
Recruiting
Conditions
Solid Tumor
Interventions
Setidegrasib; Cetuximab; Leucovorin; Oxaliplatin; Fluorouracil; Irinotecan; Nanoparticle albumin-bound-paclitaxel; Gemcitabine; Docetaxel; Pembrolizumab; Cisplatin; Carboplatin; Pemetrexed; Liposomal Irinotecan
Arms
  • ASP3082 Dose Escalation (Monotherapy Part 1) · Experimental
  • ASP3082 Dose Expansion (Monotherapy Part 2) · Experimental
  • ASP3082 + Cetuximab Dose Escalation (Combination Therapy Part 1) · Experimental
  • ASP3082 + Cetuximab Dose Expansion (Combination Therapy Part 2) · Experimental
  • ASP3082 China Safety Cohort · Experimental
  • Treatment naive PDAC cohort ASP3082 + FOLFIRINOX · Experimental
  • Treatment naive PDAC cohort ASP3082 + Nab-Paclitaxel + Gemcitabine · Experimental
  • ASP3082 + Docetaxel - NSCLC · Experimental
  • ASP3082 + Pembrolizumab - NSCLC · Experimental
  • ASP3082 + (Cisplatin or Carboplatin) and Pemetrexed +/- Pembrolizumab - NSCLC · Experimental
  • Treatment naive PDAC cohort ASP3082 + NALIRIFOX · Experimental
Enrollment
681 (estimated)
Primary outcomes
  • Incidence of Dose Limiting Toxicities (DLTs)
  • Number of Participants with Adverse Events (AEs)
  • Number of Participants with Serious Adverse Events (SAEs)
  • Number of Participants with laboratory value abnormalities and/or adverse events (AEs)
  • Number of Participants with electrocardiogram (ECG) abnormalities and/or adverse events (AEs)
  • Number of Participants with vital sign abnormalities and/or adverse events (AEs)
  • Number of Participants with physical exam abnormalities and/or adverse events
  • Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status
Sponsor
Astellas Pharma Inc
Start
Jun 8, 2022
Primary completion
Dec 31, 2028 (estimated)
Results posted
No
Registry record
NCT05382559 · updated Sep 30, 2026

Publications

linked from the registry
  • Park W, Kasi A, Spira AI, Paz-Ares Rodriguez L, Herzberg BO, Pelster MS, Tolcher AW, Kuboki Y, Kitano S, Shoji H, Wang JS, Berlin JD, Hollebecque A, LoRusso P, Fountzilas C, Cassier PA, Nishina T, Sakai D, Inagaki C, Morgensztern D, Ueno M, Jung M, Kim SW, Janne PA, Italiano A, You B, Macarulla T, Fujii H, Shetty A, Lu Y, Cui D, Kadam S, Gill SC, Toyoshima J, Saito T, Goldman JW. Setidegrasib in Advanced Non-Small-Cell Lung Cancer and Pancreatic Cancer. N Engl J Med. 2026 Apr 9;394(14):1409-1420. doi: 10.1056/NEJMoa2600752. Epub 2026 Mar 25. PubMed 41879829