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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-08

Study Completion Date

2025-08-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer

NCT06439888

Oligometastatic Disease Solid Tumor, Adult

RECRUITING PHASE1/PHASE2

A Phase 2 Intratumoral Injection PF-3512676 Plus Local Radiation in Low-Grade B-Cell Lymphomas

NCT00880581

Lymphoma, Non-Hodgkin Lymphoma Lymphomas: Non-Hodgkin Follicular / Indolent B-Cell +1 more

COMPLETED PHASE2

Lenvatinib and Pembrolizumab in Differentiated Thyroid Cancers (DTC)

NCT02973997

Columnar Cell Variant Thyroid Gland Papillary Carcinoma Follicular Variant Thyroid Gland Papillary Carcinoma Metastatic Thyroid Gland Follicular Carcinoma +23 more

COMPLETED PHASE2

Ipilimumab and Local Radiation for Selected Solid Tumors

NCT01769222

Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma +31 more

TERMINATED PHASE1

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

NCT04663347

Diffuse Large B-Cell Lymphoma Follicular Lymphoma

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-CNS Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Part 1 is sequential, Part 2 is parallel (randomized)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radiotherapy + GEN1042

Group Type EXPERIMENTAL

GEN1042

Intervention Type BIOLOGICAL

Intravenous

Radiotherapy

Intervention Type RADIATION

Radiotherapy

Radiotherapy + GEN1042 + Pembrolizumab

Group Type EXPERIMENTAL

GEN1042

Intervention Type BIOLOGICAL

Intravenous

Pembrolizumab

Intervention Type DRUG

Intravenous

Radiotherapy

Intervention Type RADIATION

Radiotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GEN1042

Intravenous

Intervention Type BIOLOGICAL

Pembrolizumab

Intravenous

Intervention Type DRUG

Radiotherapy

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No