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Metastatic/Locally Advanced Non-Small-Cell Lung CancerPhase 2UNLOCK ASP3082NCT07483983

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

A Phase 2 study testing ASP3082 in people with Metastatic/Locally Advanced Non-Small-Cell Lung Cancer and Metastatic/Locally Pancreatic Ductal Adenocarcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 7 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ASP3082
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
7 sitesFrance
Study dates
25 Mar 2026to Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • Patients with histologically confirmed diagnosis of locally advanced (unresectable) or metastatic NSCLC (cohort 1) or PDAC (cohort 2) and documented KRAS G12D mutation on the most recent tumor biopsy or circulating tumor DNA (ctDNA) analysis
  • For patients with NSCLC :
  • Patients with no known targetable genomic alterations, or an alteration for which no targeted therapy is approved (or accessible), 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
  • 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
  • Patients with PDAC must have received only one prior line of chemotherapy for a minimum duration of 5 months and have experienced disease progression
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  • Patients must have an ECOG performance status ≤1 at the time of screening
  • Patients must have a minimum life expectancy of 3 months
  • Patients must have at least one radiologically measurable lesion according to response evaluation criteria in solid tumors (RECIST) v1.1 criteria
  • Patients must have a tumor site easily accessible to biopsy, avoiding bone biopsy when possible. Patient must have accepted to perform pre-treatment, on-treatment, and end-of-treatment tumor and blood biopsies
  • Patients must have 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 × 109/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 × 109/L (use of growth factors is not allowed in the 14 days prior cycle 1)
  • Creatinine clearance (CrCl) : 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
  • Patients must have baseline oxygen saturation > 93% on room air
  • Females of reproductive/childbearing potential must have a negative serum or urine pregnancy test at screening and must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 6 months for females after the last dose of study drug.
  • Female patients must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 6 months after the final study drug administration
  • Male patients must be surgically sterile or must withhold heterosexual intercourse or must be willing to use a highly effective birth control upon enrollment, during the treatment period, and for at least 3 months following the last dose of study drug
  • Male patients must not freeze or donate sperm starting at screening and throughout the study period, and at least 3 months after the final study drug administration
  • Patients must understand, sign and date the written informed consent form prior to any protocol-specific procedures performed. Patients should be able and willing to comply with study visits and procedures as per protocol
  • Patients must be affiliated to a Social Security System or beneficiary of the same.

Who cannot join

  • Patients unwilling to participate in the biological investigations and to perform blood and tissue sample collection as required in the protocol
  • Patients with NSCLC or PDAC amenable for treatment with curative intent
  • Patients with a history of severe hypersensitivity reactions to either the drug substances or any components of the formulation used
  • Inadequate washout period prior to cycle 1 day 1, defined as:
  • Whole brain radiation therapy or stereotactic brain radiation therapy <14 days
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation <28 days or palliative radiation therapy <7 days. Participant must have recovered from all radiation-related toxicities and not have active radiation pneumonitis.
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  • Any investigational agents or other anticancer drug(s), including immunotherapy, from a previous cancer treatment regimen or clinical study <21 days or <5 half-lives, whichever is shorter, prior to first dose of ASP3082
  • Major surgery (excluding placement of vascular access) < 28 days
  • Live virus and live-attenuated vaccination <28 days
  • Systemic steroid therapy or other immunosuppressive therapy < 7 days.
  • Prior treatment with a specific KRAS G12D inhibitor/degrader or pan-RAS inhibitor/degrader targeting KRAS G12D
  • Evidence of spinal cord compression or brain metastases, defined as being clinically active (symptomatic), or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms or untreated. Patients with treated brain metastases and clinically inactive (asymptomatic) (i.e., without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the study. Patients must have a stable neurologic status for at least 28 days prior to cycle 1 day 1.
  • Patients with evidence of any leptomeningeal disease
  • Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade 1 or baseline according to the NCI-CTCAE v5.0
  • Any evidence of primary malignancy other than metastatic/locally advanced NSCLC or PDAC within 2 years prior to cycle 1 day 1, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated
  • Any evidence of severe or uncontrolled systemic diseases including active bleeding diatheses, active infection, psychiatric illness/social situations, geographical factors, substance abuse, or other factors which in the Investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required
  • Patients have an active infection requiring intravenous antibiotic within 14 days prior cycle 1 day 1
  • Patients with clinically significant pleural effusion will be excluded and ascites requiring medical treatment within 30 days prior to ICF signature.
  • Uncontrolled or significant cardiovascular disease prior to cycle 1 day 1, including:
  • 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
  • Participant with active hepatitis B (including acute HBV or chronic HBV) or HCV (RNA detected by qualitative assay). HCV RNA testing is not required in participants with negative HCV antibody testing.
  • Patient with diagnosis of human immunodeficiency virus (HIV). Patients with HIV infection on antiviral therapy and undetectable viral load are allowed with a requirement for regular monitoring for reactivation for the duration of treatment on study per local or institutional guidelines
  • Female patients who are pregnant or breastfeeding or intend to become pregnant during the study and for 6 months after study intervention administration
  • Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Patients under guardianship, curatorship, judicial protection, family habilitation or deprived of his/her liberty by a judicial or administrative decision or incapable of giving his/her consent
  • Patients require treatment with concomitant drugs that are strong inhibitors or inducers of CYP3A or CYP2D6
  • Participant requires treatment with concomitant drugs that are sensitive substrates of CYP2C8
  • Participation in another clinical trial (<30 days or <5 half-lives, whichever is longer) evaluating an experimental drug (except non-interventional research) and while on study treatment.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yohann Loriot, MD, PhD contact

+33 (0)1 42 11 42 11

Yohann.LORIOT@gustaveroussy.fr

Chloé Serhal, PhD contact

+33 (0)1 42 11 42 11 ext 23 43

chloe.serhal@gustaveroussy.fr

7 sites in 1 country

France7 sites, 7 recruiting

  • Institut Bergonié

    Bordeaux

    Véronique DEBIEN, +33 (0)5 56 33 33 33, v.debien@bordeaux.unicancer.fr

    Recruiting

  • Centre Georges François Leclerc

    Dijon

    François GHIRINGHELLI, +33 (0)3 80 73 75 06, dghiringhelli@cgfl.fr

    Recruiting

  • Institut Paoli Calmettes

    Marseille

    Brice CHANEZ, +33 (0)4 91 22 37 61, chanezb@ipc.unicancer.fr

    Not yet recruiting

  • Hôpital Paris Saint-Joseph

    Paris

    Carole Helissey, +33 (0)1 44 12 85 24, chelissey@ghpsj.fr

    Recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain

    Sandrine HIRET, +33 (0)2 40 67 99 00, sandrine.hiret@ico.unicancer.fr

    Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy

    Aurélien LAMBERT, +33 (0)3 83 59 85 64, a.lambert@nancy.unicancer.fr

    Recruiting

  • Gustave Roussy

    Villejuif, France, 94800

    Yohann Loriot, MD, PhD, +33 (0)1 42 11 42 11, Yohann.LORIOT@gustaveroussy.fr

    Fernanda Mosele, MD, mariafernanda.mosele@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

Official title: Phase 2, Multicenter, Open Label, Platform Study Investigating ASP3082 in Patients With Metastaic/Locally Non-Small-Cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Biomarker Analysis to Characterize Response/Resistance

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).

Being tested
ASP3082
Keywords
KRASG12D
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP3082Drug

    Patients enrolled in 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.

Study groups in NCT07483983
Study groupRoleWhat they receive
Cohort NSCLCExperimentalPatients with metastatic/locally advanced NSCLC with the presence of KRAS G12D mutation
Receives: Drug: ASP3082
Cohort PDACExperimentalPatients with metastatic/locally advanced PDAC with the presence of KRAS G12D mutation
Receives: Drug: ASP3082

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the best overall response (BOR) based on investigator assessment per RECIST v1.1

    Measured: Through treatment completion, median, 8 months

Secondary outcomes (11)

  1. Duration of response (DOR)

    Defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progression (PD) or death due to any cause.

    Measured: From cycle 4 (Week 9; each cycle is 21 days) up to progression

  2. Clinical benefit rate (CBR)

    defined as the presence of at least a PR or CR, or a stable disease (SD) >6 months

    Measured: During treatment period, response more than 6 months

  3. Progression-free survival (PFS)

    Defined as the time from date of first dose until the date of the first objective documentation of disease progression or death from any cause, whichever occurs first. For patients without documented radiological progression, follow-up will be censored at the date of last radiological assessment without progression, unless death occurs within 12 weeks following the date of last known progression-free, in which case the death will be counted as a PFS event

    Measured: through treatment completion, median, 8 months

  4. Overall survival (OS)

    Measured: Up to 18 months after EOT

  5. Frequency of all adverse events (AEs), treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)

    Measured: Through treatment completion, median, 8 months

  6. Severity of all adverse events (AEs), treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)

    As defined by the NCI-CTCAE v5.0

    Measured: Through treatment completion, median, 8 months

  7. Evaluate treatment discontinuation, interruptions, and dose reductions due to any AEs

    Measured: Treatment Period, median of 8 months

  8. Frequency of laboratory abnormalities

    Measured: Through treatment completion, median, 8 months

  9. Severity of laboratory abnormalities

    Defined by NCI-CTCAE v5.0

    Measured: Through treatment completion, median, 8 months

  10. To understand mecanism of action of ASP3082

    This will be evaluated through the collection of tissue and blood samples throughout study

    Measured: Through treatment completion, median, 8 months

  11. To understand the mecanism of resistance

    This will be evaluated through the collection of tissue and blood samples throughout study

    Measured: Through treatment completion, median, 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2026
  2. Study start25 Mar 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07483983
Sponsor's protocol ID
2025-522533-54-00
Other IDs
2025/4116, 2025
Acronym
UNLOCK ASP3082
Status last verified
Mar 2026
First submitted
3 Mar 2026
Last updated
5 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASP3082 in people with Metastatic/Locally Advanced Non-Small-Cell Lung Cancer and Metastatic/Locally Pancreatic Ductal Adenocarcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yohann Loriot, MD, PhD (+33 (0)1 42 11 42 11, Yohann.LORIOT@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the best overall response (BOR) based on investigator assessment per RECIST v1.1 (time frame: Through treatment completion, median, 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07483983.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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