Actively Recruiting
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
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2026-03-27
60
Participants Needed
6
Research Sites
82 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
A
Astellas Pharma Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed locally advanced (unresectable) or metastatic NSCLC or PDAC with documented KRAS G12D mutation
- For NSCLC patients without known targetable genomic alterations, prior treatment with at least one line including platinum-based regimen and PD-(L)1 blocker with progression
- For NSCLC patients with actionable genomic alterations, exhausted targeted therapy and progression after platinum-based regimen
- PDAC patients must have received one prior chemotherapy line for at least 5 months with progression
- ECOG performance status of 0 or 1 at screening
- Minimum life expectancy of 3 months
- At least one measurable lesion per RECIST v1.1
- Tumor site accessible for biopsy and consent to pre-treatment, on-treatment, and end-of-treatment biopsies
- Adequate bone marrow reserve and organ function based on labs within 21 days prior to treatment
- Baseline oxygen saturation greater than 93% on room air
- Females of reproductive potential must have negative pregnancy test and agree to use contraception or avoid intercourse during and 6 months after study
- Female patients must not donate or retrieve ova during study and 6 months after
- Male patients must be surgically sterile or agree to use birth control during and 3 months after study
- Male patients must not freeze or donate sperm during study and 3 months after
- Ability to understand and sign informed consent and comply with study visits
- Affiliation to a Social Security System or beneficiary
You will not qualify if you...
- Unwillingness to participate in biological investigations or sample collections
- NSCLC or PDAC suitable for curative treatment
- History of severe hypersensitivity to study drug or components
- Inadequate washout periods from prior therapies or treatments as specified
- Prior treatment with KRAS G12D or pan-RAS inhibitors/degraders
- Active symptomatic brain metastases or spinal cord compression; treated asymptomatic brain metastases allowed if stable
- Evidence of leptomeningeal disease
- Unresolved toxicities from previous anticancer therapy above grade 1
- Other primary malignancies within 2 years except certain treated skin or in-situ cancers
- Severe or uncontrolled systemic diseases or conditions jeopardizing compliance
- Active infection requiring IV antibiotics within 14 days prior to treatment
- Clinically significant pleural effusion or ascites needing treatment within 30 days
- Uncontrolled significant cardiovascular disease as defined
- Active hepatitis B or C infection; HIV infection allowed if controlled and monitored
- Pregnant or breastfeeding females or intending pregnancy during study and 6 months after
- Psychological, familial, sociological, or geographical conditions hampering study compliance
- Legal guardianship or inability to consent
- Need for concomitant drugs that strongly interact with CYP enzymes
- Participation in another clinical trial within 30 days or 5 half-lives of investigational drug except non-interventional research while on study treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Gustave Roussy
Villejuif, France, France, 94800
Actively Recruiting
2
Institut Bergonié
Bordeaux, France
Not Yet Recruiting
3
Centre Georges François Leclerc
Dijon, France
Not Yet Recruiting
4
Institut Paoli Calmettes
Marseille, France
Not Yet Recruiting
5
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Not Yet Recruiting
6
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
Research Team
Y
Yohann Loriot, MD, PhD
CONTACT
C
Chloé Serhal, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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