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

NCT05491317 | Terminated Phase 1 Results FDA Drug

• 4 other identifiers: GCT1042-022022-000509-292023-508529-29-00RECF-005058
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-CNS Tumor

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicities (DLTs)

  A DLT was defined as any grade 5 toxicity, treatment-related toxicity that caused the participant to discontinue treatment during Cycle 1, febrile neutropenia grade 3 or grade 4, grade 3 thrombocytopenia associated with clinically significant bleeding, grade 4 thrombocytopenia of any duration, grade 4 anemia, any grade ≥3 non-hematologic clinical (non-laboratory) toxicity with exceptions per protocol, any grade 3 or grade 4 non-hematologic laboratory value if clinically significant medical intervention was required to treat the participant or the abnormality led to hospitalization, or the abnormality persisted for \>7 days, and the abnormality resulted in a drug-induced liver injury (DILI) as defined by Hy's Law. Toxicities were graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).

  21 days

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  Up to approximately 2 years 5 months

• Duration of Response (DOR)

  Up to approximately 2 years 5 months

• Disease Control Rate (DCR)

  Up to approximately 2 years 5 months

• Progression Free Survival (PFS)

  Up to approximately 2 years 5 months

• Overall Survival (OS)

  Up to approximately 2 years 5 months

Study Arms (2)

Radiotherapy + GEN1042

EXPERIMENTAL

Biological: GEN1042; Radiation: Radiotherapy

Radiotherapy + GEN1042 + Pembrolizumab

EXPERIMENTAL

Biological: GEN1042; Drug: Pembrolizumab; Radiation: Radiotherapy

Interventions

Pembrolizumab DRUG

Intravenous

Radiotherapy + GEN1042 + Pembrolizumab

Radiotherapy RADIATION

Radiotherapy

Radiotherapy + GEN1042; Radiotherapy + GEN1042 + Pembrolizumab

GEN1042 BIOLOGICAL

Intravenous

Radiotherapy + GEN1042; Radiotherapy + GEN1042 + Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Genmab: lead
• BioNTech SE: collaborator

Study Sites (2)

Centre Leon Berard

Lyon, 69008, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Interventions

pembrolizumab; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

After reviewing all available data from Part 1 of the trial, the Sponsor decided not to proceed to Part 2 (randomized Phase 2) of the trial due to lack of efficacy.

Results Point of Contact

• Title: CLINICAL TRIAL INFORMATION
• Organization: Genmab

clinicaltrials@genmab.com

+45 7020 2728

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 is sequential, Part 2 is parallel (randomized)

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: July 2, 2026
• Results First Posted: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)