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Comments

Trial for metastatic patients with solid tumors, which includes CRC, for whom there is no available standard therapy; palliative radiotherapy may be an available option for disease management for them.
Two arms; patients are assigned to them randomly:
1. Radiotherapy in combination with a novel immunotherapy agent, GEN1042
2.  Radiotherapy, GEN1042 and pembrolizumab (immunotherapy, anti PD-1, Keytruda®)

GEN1042 (DuoBody®- CD40x4-1BB): Bispecific antibody, immunotherapy, that targets both costimulatory molecules CD40 and 4-1BB. It is administered intravenously (IV).
There is already an ongoing trial with GEN1042 (NCT04083599; see Helpful Links)

Helpful Links

Inclusion 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

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.