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

Phase 1

Recruiting

• Conditions: Metastatic Solid Malignant tumors; MedDRA version: 21.1Level: LLTClassification code: 10065143Term: Malignant solid tumour Class: 10029104; MedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-508529-29-00
• Lead Sponsor: Genmab A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-03
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 88

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 SBRT 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. Note: Other protocol defined inclusion and exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Part 1: To determine the MTD and/or RP2D of GEN1042 in combination with radiotherapy ± pembrolizumab<br>Part 2: To evaluate the abscopal response of GEN1042 in combination with radiotherapy ± pembrolizumab;Secondary Objective: To evaluate the antitumor activity of GEN1042 in combination with radiotherapy ± pembrolizumab, To evaluate the safety and tolerability of GEN1042 in combination with radiotherapy ± pembrolizumab, To characterize the PK and immunogenicity of GEN1042 in combination with radiotherapy ±pembrolizumab;Primary end point(s): Part 1: Dose Limiting Toxicities (DLTs), Part 2: Number of Participants with Abscopal Response in Non-irradiated Target Lesions

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Parts 1 and 2: Objective Response Rate (ORR) per RECIST v1.1 as assessed by investigator.;Secondary end point(s):Parts 1 and 2: Duration of Response (DOR) per RECIST v1.1 as assessed by investigator.;Secondary end point(s):Parts 1 and 2: Disease Control Rate (DCR) per RECIST v1.1 as assessed by investigator.;Secondary end point(s):Parts 1 and 2: Progression Free Survival (PFS) per RECIST v1.1 as assessed by investigator.;Secondary end point(s):Parts 1 and 2: Overall Survival (OS);Secondary end point(s):Part 1: Number of Participants With Abscopal Response in Non-irradiated Target Lesions;Secondary end point(s):Parts 1 and 2: Incidence and severity Adverse Events (AEs) and safety laboratory parameters.;Secondary end point(s):Parts 1 and 2: Pharmacokinetics (PK) parameter;Secondary end point(s):Parts 1 and 2: Number of Participants with Anti-drug Antibodies (ADAs)