OncoMatch/Clinical Trials/NCT07483983
Study Investigating ASP3082 in Patients With Metastatic/Locally Advanced Non-small-cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response/Resistance
Is NCT07483983 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies ASP3082 for metastatic/locally advanced non-small-cell lung cancer.
Treatment: ASP3082 — UNLOCK ASP3082 is an open label, single arm, multicenter, phase 2 platform study that aims to evaluate the mechanisms of action and resistance to ASP3082 in metastatic/locally advanced Non-Samll-Cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC) with the presence of KRAS G12D mutation. The two cohorts of patients are the following : i. cohort NSCLC : patients with NSCLC with KRAS G12D mutation. ii. cohort PDAC : patients with PDAC with KRAS G12D mutation. Patients enrolled in the both cohorts will receive treatment with ASP3082 at the dose of 600 mg QW thereafter in a 21-day cycle. ASP3082 will be administred in intravenous route until disease progression, unacceptable toxicity, or consent withdrawal. Tumor and blood samples will be collected at baseline, on-treatment and at the end of treatment visit only from patients who develop acquired resistance (acquired resistance is defined as a best response of CR, PR, or SD lasting more than 6 months, followed by PD).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Pancreatic Cancer
Biomarker criteria
Required: KRAS G12D mutation
documented KRAS G12D mutation on the most recent tumor biopsy or circulating tumor DNA (ctDNA) analysis
Disease stage
Metastatic disease required
locally advanced (unresectable) or metastatic NSCLC (cohort 1) or PDAC (cohort 2)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — NSCLC
must have been treated with at least 1 line of prior therapy, including a platinum-based regimen and a PD-(L) 1 blocker, combined or sequenced, and they must have experienced progression
Must have received: anti-PD-1/PD-L1 therapy — NSCLC
must have been treated with at least 1 line of prior therapy, including a platinum-based regimen and a PD-(L) 1 blocker, combined or sequenced, and they must have experienced progression
Must have received: targeted therapy — NSCLC
Patients who have known actionable genomic alterations (EGFR, BRAF, and MET mutations or ALK, ROS1, RET, NTRK fusions) must have exhausted the available targeted therapy and have experienced disease progression after a platinum-based regimen
Must have received: chemotherapy — PDAC
Patients with PDAC must have received only one prior line of chemotherapy for a minimum duration of 5 months and have experienced disease progression
Cannot have received: KRAS G12D inhibitor/degrader or pan-RAS inhibitor/degrader targeting KRAS G12D
Prior treatment with a specific KRAS G12D inhibitor/degrader or pan-RAS inhibitor/degrader targeting KRAS G12D
Lab requirements
Blood counts
Platelet count ≥100 000/mm3 or ≥100 × 10^9/L (platelet transfusions not allowed up to 14 days prior to cycle 1 Day 1); Hemoglobin (Hgb) ≥9.0 g/dL (transfusion/growth factor support allowed); Absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5 × 10^9/L (growth factors not allowed in 14 days prior cycle 1)
Kidney function
Creatinine clearance (CrCl) ≥60 mL/min as calculated using Cockcroft-Gault equation or measured CrCl; confirmation of CrCl only required when SCr is >1.5 × ULN
Liver function
AST/ALT and ALP <3 x ULN (or <5 x ULN for patients with liver metastases); total bilirubin <1.5 x ULN (<3 x ULN in Gilbert's Syndrome) or <2 x ULN for patients with liver metastases; serum albumin ≥ 3.0 g/dL
Cardiac function
Corrected QT interval >470 ms for females and >450 ms for males (QTcF) assessed by ECG; LVEF <50% by ECHO or MUGA scan; Myocardial infarction or unstable angina within 6 months; NYHA > class II within 6 months; Clinically significant pericardial effusion as determined by ECHO or MUGA scan; Symptomatic congestive heart failure, clinically significant cardiac disease
adequate bone marrow reserve and organ function, based on local laboratory data within 21 days prior to cycle 1, day 1 defined as: Platelet count ≥100 000/mm3 or ≥100 × 10^9/L (platelet transfusions are not allowed up to 14 days prior to cycle 1 Day 1 to meet eligibility); Hemoglobin (Hgb) ≥9.0 g/dL (transfusion and/or growth factor support is allowed); Absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5 × 10^9/L (use of growth factors is not allowed in the 14 days prior cycle 1); Creatinine clearance (CrCl) ≥60 mL/min as calculated using the Cockcroft-Gault equation or measured CrCl; confirmation of CrCl is only required when SCr is >1.5 × ULN; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) and alkaline phosphatase (ALP) <3 x ULN (or <5 x ULN for patients with liver metastases); Total bilirubin (TBL) <1.5 x ULN (<3 x ULN in the presence of documented Gilbert's Syndrome [unconjugated hyperbilirubinemia]) or <2 X ULN for patients with liver metastases; Serum albumin ≥ 3.0 g/dL; Prothrombin time (PT) or Prothrombin time- international normalized ratio (PT-INR) and activated partial thromboplastin time (aPTT)/partial thromboplastin time (PTT) ≤1.5 × (ULN), except for patients on coumarin-derivative anticoagulants or other similar anticoagulant therapy, who must have PT-INR within therapeutic range as deemed appropriate by the Investigator. Corrected QT interval >470 ms for females and >450 ms for males according to Fridericia's formula (QTcF) assessed by ECG; LVEF <50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan; Myocardial infarction or unstable angina within 6 months; NYHA > class II within 6 months; Clinically significant pericardial effusion as determined by an ECHO or MUGA scan; Symptomatic congestive heart failure, clinically significant cardiac disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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