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Clinical Trial Finder

Search Results

A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors

Study Purpose

The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

  • - Participants with histologically confirmed non-central nervous system (CNS) solid tumor that is metastatic and for whom there is no available standard therapy.
  • - At least 18 years of age.
  • - Signed informed consent prior to any screening procedures.
  • - Measurable disease according to RECIST v1.1.
  • - Life expectancy of >3 months.
  • - Qualify for palliative radiotherapy as an available option for disease management.
  • - Eastern Cooperative Oncology Group (ECOG) 0-1.
  • - Normal or adequate liver, renal, cardiac and bone marrow function.
Key

Exclusion Criteria:

  • - Prior malignancy except for non-melanoma skin cancers and in situ cancers.
  • - Condition contraindicating radiotherapy.
  • - Rapidly progressing disease.
  • - Active, known or suspected autoimmune disease.
  • - History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
  • - Contraindications to the use of pembrolizumab.
  • - Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment.
  • - Received an allogeneic tissue/solid organ transplant.
  • - Active infection requiring systemic therapy.
Note: Other protocol defined inclusion and exclusion criteria may apply.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05491317
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Genmab
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Official
Principal Investigator Affiliation Genmab
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Non-CNS Tumor
Additional Details

The study will be conducted in two parts: Part 1 (dose-finding) and Part 2 (randomization). Part 1 will evaluate the safety of immunoradiotherapy combinations and establish the dose(s) to be evaluated in Part 2. Part 2 will evaluate the anti-tumor activity of immunoradiotherapy combinations at the established dose(s) from Part 1. Participants in both parts are treated with one of the following combinations:

  • - Radiotherapy + GEN1042.
  • - Radiotherapy + GEN1042 + Pembrolizumab.
While participants in Part 1 are assigned sequentially (GEN1042 without pembrolizumab is investigated first), participants in Part 2 are randomized 1:1 in the two treatment arms.

Arms & Interventions

Arms

Experimental: Radiotherapy + GEN1042

Experimental: Radiotherapy + GEN1042 + Pembrolizumab

Interventions

Biological: - GEN1042

Intravenous

Drug: - Pembrolizumab

Intravenous

Radiation: - Radiotherapy

Radiotherapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Institut Bergonie, Bordeaux, France

Status

Address

Institut Bergonie

Bordeaux, , 33076

Centre Leon Berard, Lyon, France

Status

Address

Centre Leon Berard

Lyon, , 69008

Institut Gustave Roussy, Villejuif, France

Status

Address

Institut Gustave Roussy

Villejuif, , 94805

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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