Clinical trial · Interventional
A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors
A Phase 1 Dose Finding and Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Clinical Activity of Immunoradiotherapy Combinations as a Treatment Option in Subjects With Metastatic Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): After reviewing all available data from Part 1 of the trial, the Sponsor has decided not to proceed to Part 2 (randomized Phase 2) of the trial due to lack of efficacy
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-CNS Tumor | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GEN1042 | Biological | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy + GEN1042
- interventionNames
- Biological: GEN1042
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Radiotherapy + GEN1042 + Pembrolizumab
- interventionNames
- Biological: GEN1042
- Drug: Pembrolizumab
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Number of Participants With Dose Limiting Toxicities (DLTs)
- timeFrame
- 21 days
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available