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Tests treatment safety and results for Advanced Solid Tumors
Official title Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07387068
What this study is testing
What is GEN1079?
GEN1079 is an investigational medicine, being studied as a potential treatment for advanced solid tumors.
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
- The purpose of this trial is to learn about the safety and effectiveness of the antibody GEN1079 in participants with certain types of cancer. The trial has multiple parts.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- Key All Parts:
- Must have histologically confirmed selected solid cancers.
- Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The measurable lesion(s) must be outside the field...
- Must provide formalin-fixed paraffin-embedded tumor tissue (aspirates and bone specimens are not acceptable), archival or fresh, collected after...
- Has acceptable laboratory test results prior to trial treatment administration, including platelet count \>150×10\^9/litre (L). Parts 1 and 2:
You likely can't join if
- Has intercurrent illness or known history of any of the following that could affect compliance with the protocol or interpretation of the results...
- Autoimmune diseases, eg, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), neuromyelitis optica (NMO), myasthenia gravis (MG), cold...
- Grade ≥3 allergic reactions to prior monoclonal antibody therapy.
- Known history of interstitial lung disease (ILD) Grade ≥3 or prior or ongoing noninfectious pneumonitis with evidence of progressive fibrotic changes...
- Disorders associated with platelet function defects, decreased number of platelets (eg, splenomegaly, chronic liver disease or bleeding disorders...
- Treatment with any plasma-based therapy within 7 days prior to Cycle 1 Day 1.
See the full eligibility criteria
- Key All Parts:
- Must have histologically confirmed selected solid cancers.
- Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The measurable lesion(s) must be outside the field of prior radiation therapy unless there is documented progression in...
- Must provide formalin-fixed paraffin-embedded tumor tissue (aspirates and bone specimens are not acceptable), archival or fresh, collected after discontinuation of their most recent anticancer treatment and prior to the...
- Has acceptable laboratory test results prior to trial treatment administration, including platelet count \>150×10\^9/litre (L). Parts 1 and 2:
- Have histologically confirmed selected solid cancers that are metastatic or unresectable.
- Prior protocol defined therapy is permitted, with no restrictions on the number of prior lines of therapy received or the time since the most recent therapy. Part 3:
- Have histologically confirmed selected solid cancer that is metastatic or unresectable.
- Must have received a defined number of prior lines of a protocol defined regimen. Key
- Has intercurrent illness or known history of any of the following that could affect compliance with the protocol or interpretation of the results, including but not limited to:
- Autoimmune diseases, eg, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), neuromyelitis optica (NMO), myasthenia gravis (MG), cold agglutinin disease (CAD), atypical hemolytic uremic syndrome (aHUS)...
- Grade ≥3 allergic reactions to prior monoclonal antibody therapy.
- Known history of interstitial lung disease (ILD) Grade ≥3 or prior or ongoing noninfectious pneumonitis with evidence of progressive fibrotic changes on baseline imaging, unless clinically and radiologically stable for...
- Disorders associated with platelet function defects, decreased number of platelets (eg, splenomegaly, chronic liver disease or bleeding disorders such as hemophilia or Von Willebrand disease), or a known history or high...
- Treatment with any plasma-based therapy within 7 days prior to Cycle 1 Day 1.
- Any history of intracerebral arteriovenous malformation (shunts), cerebral aneurysm, spinal cord compression (from disease), carcinomatous meningitis, or stroke. Note: Transient ischemic attack \>1 month prior to...
- Participants who, in the event of a medical complication during the trial treatment period, would be unable to temporarily discontinue and restart anticoagulant/antiplatelet therapy using appropriate bridging strategies...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Grand Rapids, Michigan, United States
- Lake Success, New York, United States
- Logroño, La Rioja, Spain
- Pozuelo de Alarcón, Madrid, Spain
- Pamplona, Navarre, Spain
- Barcelona, Spain
- Madrid, Spain
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 New Haven, Connecticut, United States; Grand Rapids, Michigan, United States; Lake Success, New York, United States; Logroño, La Rioja, Spain; Pozuelo de Alarcón, Madrid, Spain; Pamplona, Navarre, Spain and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.