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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Genmab A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

8 Mar 2023 → 11 Aug 2025

Decision date (initial)

2024-08-07

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Genmab A/S

External identifiers

EU CT number

2023-508529-29-00

EudraCT number

2022-000509-29

ClinicalTrials.gov

NCT05491317

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacodynamic, Others, Pharmacokinetic

Part 1: To determine the MTD and/or RP2D of GEN1042 in combination with radiotherapy ± pembrolizumab
Part 2: To evaluate the abscopal response of GEN1042 in combination with radiotherapy ± pembrolizumab

Secondary objectives 3

1. To evaluate the antitumor activity of GEN1042 in combination with radiotherapy ± pembrolizumab
2. To evaluate the safety and tolerability of GEN1042 in combination with radiotherapy ± pembrolizumab
3. To characterize the PK and immunogenicity of GEN1042 in combination with radiotherapy ±pembrolizumab

Conditions and MedDRA coding

Metastatic Solid Malignant tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Participants with histologically confirmed non-central nervous system (CNS) solid tumor that is metastatic and for whom there is no available standard therapy.
2. At least 18 years of age.
3. Signed informed consent prior to any screening procedures.
4. Measurable disease according to RECIST v1.1.
5. Life expectancy of >3 months.
6. Qualify for palliative SBRT as an available option for disease management.
7. Eastern Cooperative Oncology Group (ECOG) 0-1.
8. Normal or adequate liver, renal, cardiac and bone marrow function

Exclusion criteria 9

1. Prior malignancy except for non-melanoma skin cancers and in situ cancers.
2. Condition contraindicating radiotherapy.
3. Rapidly progressing disease.
4. Active, known or suspected autoimmune disease.
5. History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
6. Contraindications to the use of pembrolizumab.
7. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment.
8. Received an allogeneic tissue/solid organ transplant.
9. Active infection requiring systemic therapy. Note: Other protocol defined inclusion and exclusion criteria may apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part 1: Dose Limiting Toxicities (DLTs)
2. Part 2: Number of Participants with Abscopal Response in Non-irradiated Target Lesions

Secondary endpoints 9

1. Parts 1 and 2: Objective Response Rate (ORR) per RECIST v1.1 as assessed by investigator.
2. Parts 1 and 2: Duration of Response (DOR) per RECIST v1.1 as assessed by investigator.
3. Parts 1 and 2: Disease Control Rate (DCR) per RECIST v1.1 as assessed by investigator.
4. Parts 1 and 2: Progression Free Survival (PFS) per RECIST v1.1 as assessed by investigator.
5. Parts 1 and 2: Overall Survival (OS)
6. Part 1: Number of Participants With Abscopal Response in Non-irradiated Target Lesions
7. Parts 1 and 2: Incidence and severity Adverse Events (AEs) and safety laboratory parameters.
8. Parts 1 and 2: Pharmacokinetics (PK) parameter
9. Parts 1 and 2: Number of Participants with Anti-drug Antibodies (ADAs)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Genmab A/S

Sponsor organisation

Genmab A/S

Address

Carl Jacobsens Vej 30

City

Valby

Postcode

2500

Country

Denmark

Scientific contact point

Organisation

Genmab A/S

Contact name

Clinical trial information

Public contact point

Organisation

Genmab A/S

Contact name

Clinical trial information

Third parties 13

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications