Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
863
Countries
5
Sites
28
Malignant solid tumors: Patients with relapsed or refractory, advanced and/or metastatic melanoma, Non-Small Cell Lung Cancer (NSCLC), Head and neck squamous cell carcinoma (HNSCC), Panctreatic ductal adenocarcinoma (PDAC) or Colorectal Cancer (CRC).
For dose escalation and safety run-in: • To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of GEN1042 administered alone or in combination with pembrolizumab with or without chemotherapy For dose expansion as monotherapy and in combination: • To evaluate the anti-tumor activity of GE…
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
- 1 Oct 2019 → ongoing
- Decision date (initial)
- 2024-06-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508526-10-00
- EudraCT number
- 2018-003716-47
- ClinicalTrials.gov
- NCT04083599
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
For dose escalation and safety run-in:
• To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of GEN1042 administered alone or in combination with pembrolizumab with or without chemotherapy
For dose expansion as monotherapy and in combination:
• To evaluate the anti-tumor activity of GEN1042 administered as monotherapy and in combination with pembrolizumab with or without chemotherapy
Secondary objectives 1
- • To evaluate the safety and tolerability of GEN1042 administered as monotherapy and in combination with pembrolizumab with or without chemotherapy • To evaluate the anti-tumor activity of GEN1042 administered as monotherapy and in combination with pembrolizumab with or without chemotherapy • To characterize the pharmacokinetics (PK) and immunogenicity of GEN1042 administered as monotherapy or in combination with pembrolizumab with or without chemotherapy
Conditions and MedDRA coding
Malignant solid tumors: Patients with relapsed or refractory, advanced and/or metastatic melanoma, Non-Small Cell Lung Cancer (NSCLC), Head and neck squamous cell carcinoma (HNSCC), Panctreatic ductal adenocarcinoma (PDAC) or Colorectal Cancer (CRC).
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065143 | Malignant solid tumour | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Monotherapy • Combination Therapy As defined in the protocol section Inclusion criteria
Exclusion criteria 1
- • Monotherapy • Combination Therapy As defined in the protocol section exclusion criteria
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- For dose escalation and safety run-in: • Dose-limiting toxicity (DLT) For dose expansion as monotherapy and in combination: • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
Secondary endpoints 1
- - Adverse events (AEs) and safety laboratory parameters - ORR per RECIST 1.1 by investigator assessment (for dose escalation only) • Duration of response (DOR) per RECIST 1.1 by investigator assessment • Disease Control Rate (DCR) per RECIST 1.1 by investigator assessment • Progression-free survival (PFS) per RECIST 1.1 by investigator assessment • OS - PK parameters and anti-drug antibodies (ADAs)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 9
SCP111841108 · ATC
- Active substance
- Pemetrexed Disodium
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01BA04 — PEMETREXED
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1128788 · ATC
- Active substance
- Gemcitabine Hydrochloride
- Substance synonyms
- 4-AMINO-1-[(2R,4R,5R)-3,3-DIFLUORO-4-HYDROXY-5-(HYDROXYMETHYL)OXOLAN-2-YL]PYRIMIDIN-2-ONE HYDROCHLORIDE
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10337134 · ATC
- Active substance
- Carboplatin
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Abraxane 5 mg/ml powder for dispersion for infusion.
PRD9254301 · Product
- Active substance
- Paclitaxel Albumin-Bound
- Substance synonyms
- PACLITAXEL ALBUMINE-BOUND
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- EU/1/07/428/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP129816 · ATC
- Active substance
- Paclitaxel
- Substance synonyms
- ONCOGEL, ABI-007, MBT 0206
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6822253 · Product
- Active substance
- Tecaginlimab
- Substance synonyms
- GEN1042, DUOBODY-CD40XCD137, BNT-312, HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST CD40 AND 4-1BB
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Not Authorised
- MA holder
- GENMAB
- Paediatric formulation
- No
- Orphan designation
- No
SCP1165178 · ATC
- Active substance
- Fluorouracil
- Substance synonyms
- 5-FLOUROURACIL, 5-FLUORO-1H-PYRIMIDINE-2,4-DIONE, 5-FLUOROURACIL, 5-FU
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP134220 · ATC
- Active substance
- Cisplatin
- Substance synonyms
- CDDP, Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP6094344 · ATC
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, CT P51, SYS6036, QL-2107, ABP 234
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- L01XC18 — PEMBROLIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- Genmab Trial Information
Public contact point
- Organisation
- Genmab A/S
- Contact name
- Genmab Trial Information
Third parties 17
| Organisation | City, country | Duties |
|---|---|---|
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| BioAgilytix Europe GmbH ORG-100016335
|
Hamburg, Germany | Other |
| Fortrea Development Limited ORG-100009463
|
Maidenhead, United Kingdom | Other, Code 8 |
| Cerba Research ORG-100042694
|
Gent, Belgium | Other, Laboratory analysis |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Other |
| Icon Laboratory Services Inc. ORG-100037135
|
Farmingdale, United States | Other |
| BioNTech SE ORG-100014714
|
Mainz, Germany | Other |
| Syneos Health Netherlands B.V. ORG-100013861
|
Amsterdam, Netherlands | On site monitoring, Code 12, Code 2, Code 5, Data management, E-data capture |
| Genmab US Inc. ORG-100046328
|
Plainsboro, United States | Other |
| ARENSIA Exploratory Medicine GmbH ORG-100049248
|
Duesseldorf, Germany | Code 12, Code 2, Code 5 |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Other, E-data capture |
| Pharma Bio-Research Group ORG-100012586
|
Assen, Netherlands | Other |
| Mlm Medical Labs GmbH ORG-100043721
|
Mönchengladbach, Germany | Other |
| Tigermed-Bdm Inc. ORG-100047921
|
Somerset, United States | Code 10 |
| Q Squared Solutions LLC ORG-100043195
|
Durham, United States | Other |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Other |
Locations
5 EU/EEA countries · 28 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 35 | 3 |
| France | Ongoing, recruitment ended | 24 | 2 |
| Germany | Ongoing, recruitment ended | 7 | 2 |
| Italy | Ongoing, recruitment ended | 15 | 4 |
| Spain | Ongoing, recruitment ended | 189 | 17 |
| Rest of world
Taiwan, Korea, Republic of, Moldova, Republic of, Georgia, United States, Israel, United Kingdom
|
— | 593 | — |
Investigational sites
Lillebaelt Hospital
Oncology, Beriderbakken 4, 7100, Vejle
Rigshospitalet
Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Region Hovedstaden
Oncology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Institut Gustave Roussy
Head and neck, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Bordeaux
Medical oncology, 1 Rue Jean Burguet, 33000, Bordeaux
Universitaetsklinikum Heidelberg AöR
Section of DermatoOncology, Department of Dermatology and National Center for Tumor diseases (NCT), Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Universitaetsklinikum Wuerzburg AöR
Department of Dermatology, Venerology and Allergology, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
Humanitas Mirasole S.p.A.
Oncology, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Santa Croce E Carle
Oncology, Via Michele Coppino 26, 12100, Cuneo
Fondazione IRCCS Istituto Nazionale Dei Tumori
Oncology, Via Giacomo Venezian 1, 20133, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Oncology, Piazzale Spedali Civili 1, 25123, Brescia
Clinica Universidad De Navarra
Immunology and Immunotherapy, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Virgen De La Victoria
Medical Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitari Vall D Hebron
Oncology Department, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Institut Catala D'oncologia
Oncología, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
MD Anderson Cancer Center
Oncology Service, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitario Ramon Y Cajal
Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
Immunology and Immunotherapy, Avenue Pio XII 36, 31008, Pamplona
University Hospital Virgen Del Rocio S.L.
Oncología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Complejo Hospitalario Universitario Insular Materno Infantil
Oncología, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Hospital General Universitario Gregorio Maranon
Oncología, Calle Del Doctor Esquerdo 46, 28007, Madrid
Complexo Hospitalario Universitario De Santiago
Oncología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Clinico San Carlos
Oncología, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Hm Nou Delfos
Oncología, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2019-10-01 | 2019-10-10 | 2024-02-12 | ||
| France | 2023-07-27 | 2023-08-31 | 2024-09-30 | ||
| Germany | 2021-10-21 | 2022-02-24 | 2022-12-12 | ||
| Italy | 2023-10-04 | 2023-11-24 | 2024-11-13 | ||
| Spain | 2021-04-09 | 2021-04-13 | 2024-12-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 47 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-508526-10-00_Administrative Letter | 14.0 |
| Protocol (for publication) | D1_Protocol_2023-508526-10-00_redacted | 12.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_FR | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement_ES | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Blank doc for transition | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_IT_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult Combo_IT | 3.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult Monotherapy_IT_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy and birth_IT_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future use of samples_DK | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Combination ICF_ES_Redacted | 7.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Monotherapy ICF_ES | 7.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main PP ICF_ES_Redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_combination therapy_DK | 6.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_combination therapy_FR | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_mono therapy_DK_Redacted | 7.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 7.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Partner_DK_Redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Partner_Redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_FR | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment beyond progression_DK | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject info Reimbursement Procedures_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject info Reimbursement Request Form_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material GP Letter_IT | 4.3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Ascopharm reimbursement form_FR | 4 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Patient card_combination therapy_FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject material_PI_Letter | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject material_PI_Letter | n/a |
| Subject information and informed consent form (for publication) | L2_Other subject material_PI_Letter | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_5-Fluorouracil | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cisplatin | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Gemcitabine | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Nab-paclitaxel | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Paclitaxel | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pembrolizumab | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pemetrexed Accord | n/a |
| Synopsis of the protocol (for publication) | D1_Lay_Person_Protocol Synopsis ES_2023-504802-12-00 | 12.0 |
| Synopsis of the protocol (for publication) | D1_Lay_Person_Protocol synopsis_FR_2023-508526-10 | 12.0 |
| Synopsis of the protocol (for publication) | D1_Layman_Protocol_Synopsis_EN_2023-508526-10-00 | 12.0 |
| Synopsis of the protocol (for publication) | D1_Layman_Protocol_Synopsis_IT_2023-508526-10-00 | 12.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508526-10-00_EN_redacted | 9.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508526-10-00_ES_redacted | 9.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-508526-10-00_FR_redacted | 9.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-508526-10-00_IT_Redacted | 9.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-10 | France | Acceptable 2024-06-19
|
2024-06-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-02 | France | Acceptable 2025-01-17
|
2025-01-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-26 | France | Acceptable 2025-04-04
|
2025-04-04 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-08 | Acceptable 2025-04-04
|
2025-05-08 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-29 | Acceptable | 2025-07-30 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-14 | France | Acceptable 2026-01-27
|
2026-01-27 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-06 | Acceptable 2026-04-30
|
2026-05-01 |