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New treatment option for Metastatic/Locally Advanced Non-Small-Cell Lung Cancer
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
ClinicalTrials.gov ID: NCT07483983
What this study is testing
What is ASP3082?
ASP3082 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic/locally advanced non-small-cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Patients with histologically confirmed diagnosis of locally advanced (unresectable) or metastatic NSCLC (cohort 1) or PDAC (cohort 2) and documented...
- 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...
- Patients who have known actionable genomic alterations (EGFR, BRAF, and MET mutations or ALK, ROS1, RET, NTRK fusions) must have exhausted the...
You likely can't join if
- 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- Patients with PDAC must have received only one prior line of chemotherapy for a minimum duration of 5 months and have experienced disease progression
- 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...
- 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...
- 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...
- 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...
- Patients must be affiliated to a Social Security System or beneficiary of the same.
What rules you out
- 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...
- 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...
- 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 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...
- 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...
- 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...
- 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...
- 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-treatment research) and while on study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Villejuif, France, France
- Bordeaux, France
- Dijon, France
- Marseille, France
- Saint-Herblain, France
- Vandœuvre-lès-Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Villejuif, France, France; Bordeaux, France; Dijon, France; Marseille, France; Saint-Herblain, France; Vandœuvre-lès-Nancy, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.