E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Malignant solid tumors: Patients with relapsed or refractory, advanced and/or metastatic melanoma, Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer (CRC) who are not anymore candidates for standard therapy, Head and Neck Squamous Cell Carcinoma (HNSCC) and pancreatic ductal adenocarcinoma (PDAC) |
Tumori solidi maligni: Pazienti con melanoma recidivante o refrattario, avanzato e/o metastatico, tumore al polmone non a piccole cellule (NSCLC) o tumore del colon-retto che non sono più trattabili con terapia standard, carcinoma a cellule squamose della testa e del collo (HNSCC) e adenocarcinoma duttale pancreatico (PDAC) |
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E.1.1.1 | Medical condition in easily understood language |
patients with advanced and/or metastatic melanoma, non-small cell lung cancer, colorectal cancer, head-neck cancer and pancreatic cancer |
Pazienti con melanoma avanzato e/o metastatico, tumore al polmone non a piccole cellule, tumore del colon-retto, tumore testa-collo e tumore al pancreas |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065143 |
E.1.2 | Term | Malignant solid tumour |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
Per l’aumento graduale della dose e il run-in di sicurezza: - Determinare la dose massima tollerata (MTD) e/o la dose raccomandata di fase 2 (RP2D) di GEN1042 somministrato da solo o in combinazione con pembrolizumab con o senza chemioterapia
Per l’espansione della dose in monoterapia e in combinazione: - Valutare l’attività antitumorale di GEN1042 somministrato in monoterapia e in combinazione con pembrolizumab con o senza chemioterapia |
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E.2.2 | Secondary objectives of the trial |
• 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 |
- Valutare la sicurezza e la tollerabilità di GEN1042 somministrato in monoterapia e in combinazione con pembrolizumab con o senza chemioterapia - Valutare l’attività antitumorale di GEN1042 somministrato in monoterapia e in combinazione con pembrolizumab con o senza chemioterapia - Caratterizzare la farmacocinetica (PK) e l’immunogenicità di GEN1042 somministrato in monoterapia o in combinazione con pembrolizumab con o senza chemioterapia |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Monotherapy - Combination Therapy
As defined in the protocol section Inclusion criteria |
- Monoterapia - Terapia di combinazione
Come definito nella sezione del protocollo Criteri di inclusione |
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E.4 | Principal exclusion criteria |
- Monotherapy - Combination Therapy
As defined in the protocol section Exclusion criteria |
- Monoterapia - Terapia di combinazione
Come definito nella sezione del protocollo Criteri di eclusione |
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E.5 End points |
E.5.1 | Primary end point(s) |
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 |
Per l’aumento graduale della dose e il run-in di sicurezza: - Tossicità dose-limitante
Per l’espansione della dose in monoterapia e in combinazione: - Tasso di risposta obiettiva (ORR) secondo i criteri di valutazione della risposta nei tumori solidi (RECIST) v1.1 in base alla valutazione dallo sperimentatore |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
As defined in the protocol section primary endpoint |
Come definito nella sezione endpoint primario del protocollo |
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E.5.2 | Secondary end point(s) |
- 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) |
- Eventi avversi (AE) e parametri di laboratorio per la sicurezza - ORR secondo RECIST 1.1 in base alla valutazione dello sperimentatore (solo per aumento graduale della dose) - Durata della risposta secondo RECIST 1.1 in base alla valutazione dello sperimentatore - Tasso di controllo della malattia (DCR) secondo RECIST 1.1 in base alla valutazione dello sperimentatore - Sopravvivenza libera da progressione (PFS) secondo RECIST 1.1 in base alla valutazione dello sperimentatore - Sopravvivenza globale - Parametri farmacocinetici (PK) e anticorpi anti-farmaco |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
As defined in the protocol section secondary endpoint |
Come definito nella sezione endpoint secondario del protocollo |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability, immunogenicity, biomarkers analysis |
Tollerabilità, immunogenicità, analisi dei biomarcatori |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 7 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Israel |
Korea, Republic of |
Taiwan |
United States |
France |
Spain |
Germany |
Italy |
Denmark |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial is considered completed when the last subject dies or withdraws from the trial. However, maximal trial duration is 3 years after the last subject's first treatment. |
Lo studio si considera completato quando l'ultimo soggetto muore o si ritira dallo studio. Tuttavia, la durata massima dello studio è di 3 anni dopo il primo trattamento dell'ultimo soggetto. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |