NCT05491317

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2023

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

March 8, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2025

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

August 4, 2022

Last Update Submit

February 17, 2026

Conditions

Non-CNS Tumor

Outcome Measures

Primary Outcomes (2)

  • Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)

    Toxicities will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).

    During the first cycle (Cycle length = 21 days)

  • Part 2: Number of Participants with Abscopal Response in Non-irradiated Target Lesions

    Assessed by investigator.

    Up to 12 months after the last radiation treatment

Secondary Outcomes (9)

  • Parts 1 and 2: Objective Response Rate (ORR)

    Up to 2 years

  • Parts 1 and 2: Duration of Response (DOR)

    Up to 2 years

  • Parts 1 and 2: Disease Control Rate (DCR)

    Up to 2 years

  • Parts 1 and 2: Progression Free Survival (PFS)

    Up to 2 years

  • Parts 1 and 2: One- year Overall Survival (OS)

    Up to 2 years

  • +4 more secondary outcomes

Study Arms (2)

Radiotherapy + GEN1042

EXPERIMENTAL
Biological: GEN1042Radiation: Radiotherapy

Radiotherapy + GEN1042 + Pembrolizumab

EXPERIMENTAL
Biological: GEN1042Drug: PembrolizumabRadiation: Radiotherapy

Interventions

PembrolizumabDRUG

Intravenous

Radiotherapy + GEN1042 + Pembrolizumab
RadiotherapyRADIATION

Radiotherapy

Radiotherapy + GEN1042Radiotherapy + GEN1042 + Pembrolizumab
GEN1042BIOLOGICAL

Intravenous

Radiotherapy + GEN1042Radiotherapy + GEN1042 + Pembrolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Leon Berard

Lyon, 69008, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Interventions

pembrolizumabRadiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Study Official

    Genmab

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Part 1 is sequential, Part 2 is parallel (randomized)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 8, 2022

Study Start

March 8, 2023

Primary Completion

August 11, 2025

Study Completion

August 11, 2025

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)