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

Sponsor
Genmab
Study ID
NCT05491317
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Non-CNS Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GEN1042 — BIOLOGICAL
    Intravenous
  • Pembrolizumab — DRUG
    Intravenous
  • Radiotherapy — RADIATION
    Radiotherapy

Study Details

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.

Key Dates

Start date
Mar 8, 2023
Status verified
Jun 2026
Primary completion
Aug 11, 2025
Completion
Aug 11, 2025

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Radiotherapy + GEN1042
  • Experimental: Radiotherapy + GEN1042 + Pembrolizumab

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: 21 days ]

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