For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:

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

EXCLUSION CRITERIA

Key Exclusion Criteria:

  1. Prior malignancy except for non-melanoma skin cancers and in situ cancers.
  2. Condition contraindicating radiotherapy.
  3. Rapidly progressing disease.
  4. Active, known or suspected autoimmune disease.
  5. History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
  6. Contraindications to the use of pembrolizumab.
  7. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment.
  8. Received an allogeneic tissue/solid organ transplant.
  9. Active infection requiring systemic therapy.

Note: Other protocol defined inclusion and exclusion criteria may apply.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Non-CNS Tumor

Age (in years)

18+

Phase

Phase 1/Phase 2

Participants needed

88

Est. Completion Date

Jul 31, 2026

Treatment type

Interventional


Sponsor

Genmab

ClinicalTrials.gov identifier

NCT05491317

Study number

GCT1042-02

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