Trial to Evaluate the Safety and Preliminary Efficacy of GEN1079 in Participants With Advanced Solid Tumors
Recruiting
Phase 1Interventional Study
Advanced Solid Tumors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
121 (estimated)
Sponsor
Genmab · Industry
Who this trial is looking for
This trial is looking for people with certain types of advanced cancer to test a new treatment called GEN1079. Participants will receive the treatment and undergo monitoring through various tests over the course of about 33 to 67 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with a solid cancer.
I have measurable disease based on specific guidelines.
I can provide tumor tissue from after my last cancer treatment.
I have acceptable lab results before starting treatment.
I have metastatic or unresectable cancer.
I have received prior cancer treatments as allowed.
You may not be able to join if
I have an autoimmune disease.
I have had severe allergic reactions to antibody therapy.
I have had serious lung problems in the past.
I have bleeding disorders that require treatment.
I received plasma-based therapy in the last week.
I have a history of brain or spinal issues like aneurysms or strokes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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. The first part of the trial tests different doses of GEN1079 to find out if it is safe and determine what are the best doses to use. The second and third parts continue to test the safety of and whether GEN1079 works in additi…
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. The first part of the trial tests different doses of GEN1079 to find out if it is safe and determine what are the best doses to use. The second and third parts continue to test the safety of and whether GEN1079 works in additional participants with specific cancer types and at doses chosen based on results from the previous parts of the trial.
For each participant, the trial will last approximately 33 to 67 weeks but this may vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 6 to 12 weeks of treatment (the duration of treatment may vary for each participant), and approximately 24 to 52 weeks of follow up after trial treatment ends (the duration of follow up may vary for each participant). During the screening, tumor tissue either collected prior to this trial or freshly collected during screening will be provided by all participants.
Participation in the trial will require visits to the site, with more frequent visits at the start of treatment and then less frequent visits afterwards. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography \[CT\] scans) to monitor whether the treatment is safe and effective.
All participants will receive active drug; no one will be given placebo.
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
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 documente…
Key Inclusion Criteria:
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 the lesion(s).
* 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 first administration of GEN1079. If an archival specimen is unavailable, a procedure for obtaining a fresh tumor biopsy must be performed, provided it is performed according to standard of care and is deemed safe by the investigator.
* 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 Exclusion Criteria:
* 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), immunoglobulin A (IgA) nephropathy, inflammatory bowel disease (IBD; Crohn's and ulcerative colitis).
* 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 ≥6 months with preserved pulmonary function (eg, diffusing capacity of the lungs for carbon monoxide \[DLCO\] ≥ 50% predicted).
* 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 risk of bleeding events requiring transfusions or hospitalizations.
* 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 screening is allowed.
* 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 (eg, low molecular weight heparin) in alignment with local standard of care.
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
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