Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer

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

22 Sep 2021 → ongoing

Decision date (initial)

2024-10-07

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Genmab A/S

External identifiers

EU CT number

2024-513770-22-00

EudraCT number

2021-001928-17

ClinicalTrials.gov

NCT05117242

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacodynamic, Pharmacokinetic, Therapy, Others

Evaluate the anti-tumor activity of GEN1046 as monotherapy and in combination with pembrolizumab therapy in subjects with relapsed/refractory metastatic NSCLC

Secondary objectives 3

1. - Evaluate time to onset and durability of the anti-tumor response of GEN1046 as monotherapy and in combination with pembrolizumab in subjects with relapsed/refractory metastatic NSCLC
2. - Evaluate the clinical benefit of GEN1046 as monotherapy and in combination with pembrolizumab
3. -Assess safety and tolerability of GEN1046 as monotherapy and in combination with pembrolizumab

Conditions and MedDRA coding

Malignant Solid Tumors - Non Small Cell Lung Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Subject must sign an informed consent form (ICF)
2. Subject must be at least 18 years of age on the day of signing the ICF
3. Subject has histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 -mAb for metastatic disease.
4. Subject must have a tumor PD-L1 expression result available prior to C1D1 demonstrating PD-L1 expression in ≥1% of tumor cells as assessed by a sponsor designated central laboratory using the Dako PD-L1 IHC 22C3 pharmDx assay (TPS≥1%), or per site local assessment with the Dako PD-L1 IHC 22C3 pharmDx assay (TPS≥1%) or the VENTANA PD-L1 (SP263) assay (TC ≥1%) adhering to the manufacturer’s instructions. Note: Local PD-L1 result needs to be performed on fresh tumor tissue (obtained within 3 months prior to enrollment and after failure/stop of last prior treatment) or, if not feasible, archival tissue (obtained within 12 months prior to enrollment).
5. Subject must have measurable disease per RECIST v1.1 as assessed by the investigator.
6. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
7. Subject must have life expectancy of at least 3 months
8. Subject must have adequate organ and bone marrow function as described in the protocol.

Exclusion criteria 2

1. Documentation of known EGFR sensitizing mutations, KRAS, RET, ROS1, BRAF mutations, NTRK gene infusions, RET rearrangement, ALK gene rearrangements, highlevel MET amplification, or METex 14 skipping
2. Subject has been exposed to any of the following prior therapies: •Prior treatment with docetaxel for NSCLC •Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, or autologous cell immunotherapy, •Treatment with an anti-cancer agent within 28 daysrior to GEN1046 administration.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator

Secondary endpoints 6

1. Duration of response (DOR) per RECIST v1.1. -
2. Time to response (TTR) per RECIST v1.1.
3. Progression-free survival (PFS) per RECIST v1.1
4. Overall survival (OS)
5. Incidence and severity of adverse events (AEs)
6. Incidence and severity of laboratory abnormalities

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 10

Locations

7 EU/EEA countries · 39 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

Documents 37 files

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

Application history

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