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

Sponsored by Genmab

About this trial

Last updated 7 months ago

Study ID

GCT1042-02

Status

Recruiting

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

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.

What are the Participation Requirements?

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.

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Withdrawn