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
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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 |
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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 | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
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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 |
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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 exclusion criteria |
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E.4 | Principal exclusion criteria |
- Monotherapy - Combination Therapy As defined in the protocol section exclusion criteria
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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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
As defined in the protocol section primary endpoint |
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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) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
As defined in the protocol section secondary endpoint |
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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 |
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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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 3 |
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 | No |
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 |
Taiwan |
Australia |
Israel |
Korea, Republic of |
United Kingdom |
United States |
Denmark |
Germany |
Italy |
Spain |
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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. |
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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 |