Nationales Centrum fr Tumorerkrankungen NCT Heidelberg (Baden-Württemberg) GermanyAbgeschlossen» Google-MapsKlinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen (Rheinland-Pfalz) GermanyAbgeschlossen» Google-MapsDepartment of Dermatology, University of Mainz Mainz (Rheinland-Pfalz) GermanyAbgeschlossen» Google-Maps
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1. Percentage of Subjects With Dose-Limiting Toxicities (DLT) (Time Frame - First Cycle (21 days)): Occurrence of Dose-Limiting Toxicities (DLT) assessed by the Investigator
2. Objective Response Rate (ORR) (Time Frame - From the start of the study treatment until disease progression/death/ lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first. (an expected average of 10 months)): Defined as proportion of participants who have a confirmed partial or complete response (PR or CR). Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Secondary outcome:
1. Percentage of Subjects with Adverse Events and Serious Adverse Events (Time Frame - Baseline up to 90 Days After the Last Dose, assessed up to 36 months after the last subject's first treatment in the trial.): Incidence of Adverse Events and Serious Adverse Events as assessed by NCI CTCAE V5.0
2. Duration of Object Response (DOR) (Time Frame - From the start of the study treatment until disease progression/death/ lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first. (an expected average of 10 months)): Defined as time from the first documentation of objective response (CR or PR) to the date of first PD or death.
3. Disease Control Rate (DCR) (Time Frame - From the start of the study treatment until disease progression/death/ lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first. (an expected average of 10 months)): Determined by Investigator Using RECIST Version 1.1
4. Progression-Free Survival (PFS) (Time Frame - From the start of the study treatment until disease progression/death whichever occurs first. (an expected average of 10 months)): Defined as the time from start of study treatment to first documented progression per RECIST Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.
5. Overall survival (OS) (Time Frame - From the start of the study treatment until death due to any cause, assessed up to 36 months after the last subject's first treatment in the trial.): Defined as the time from start of study treatment to date of death due to any cause.
6. Dose Escalation: Maximum Concentration (Cmax) of GEN1042 (Time Frame - Cycle (Cy) 1 Day (D) 1 before GEN1042 infusion (BI) and End of Infusion (EOI), Cy1 D2, 3, 8, 15, Cy2 BI, EOI on D1, D 2, 3, 8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)): Pharmacokinetic (PK) parameters of GEN1042, and incidence of anti-drug antibodies Dose Escalation: Maximum Concentration (Cmax) of GEN1042
7. Dose Escalation: Area Under the Concentration Time Curve (AUC) of GEN1042 (Time Frame - Cycle (Cy) 1 Day (D) 1 before GEN1042 infusion (BI) and , End of GEN1042 Infusion (EOI), Cy1 D2, 3, 8, 15, Cy2 BI, EOI on D1, D 2, 3, 8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)): Pharmacokinetic (PK) parameters of GEN1042, and incidence of anti-drug antibodies Dose Escalation: Area Under the Concentration Time Curve (AUC) of GEN1042
8. Dose Escalation: Half-life (t1/2) of GEN1042 (Time Frame - Cycle (Cy) 1 Day (D) 1 before GEN1042 infusion (BI) and End of Infusion (EOI), Cy1 D2, 3, 8, 15, Cy2 BI, EOI on D1, D 2, 3, 8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)): Dose Escalation: Half-life (t1/2) of GEN1042
9. Dose Expansion: Area Under the Concentration Time Curve (AUC) of GEN1042 (Time Frame - Cy 1 BI, EOI on D1, D8, 15, Cy 2 BI, EOI on D1, D8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)): Dose Expansion: Area Under the Concentration Time Curve (AUC) of GEN1042
10. Dose Expansion: Maximum Concentration (Cmax) of GEN1042 (Time Frame - Cy 1 BI, EOI on D1, D8, 15, Cy 2 BI, EOI on D1, D8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)): Dose Expansion: Maximum Concentration (Cmax) of GEN1042
11. Dose Escalation: Incidence of ADA response to GEN1042 (Time Frame - BI on Cy 1, 2, 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment), safety follow-up visit (SFU) (30 and 90 days post final dose) (Cy =21 days)): Dose Escalation: Incidence of ADA response to GEN1042responses to GEN1042
12. Dose Expansion: Incidence of ADA response to GEN1042 (Time Frame - BI on Cy 1, 2, 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment), SFU (30 and 90 days post final dose) (Cy =21 days)): Dose Expansion: Incidence of ADA response to GEN1042
Experimental: Monotherapy - Dose Escalation and Dose Expansion parts Escalating doses of GEN1042 monotherapy in subjects with non-central nervous system (CNS) solid malignant tumors followed by monotherapy expansion cohorts at selected dose(s) in subjects with relapsed or refractory, advanced and/or metastatic melanoma, or non-small-cell lung cancer (NSCLC), or colorectal cancer (CRC).
Experimental: Combination Therapy - Dose Expansion Part GEN1042 safety and efficacy will be evaluated in combination with pembrolizumab with or without chemotherapy in treatment-naive subjects with advanced or metastatic melanoma, non-small-cell lung cancer [NSCLC], head and neck squamous cell carcinoma [HNSCC], and pancreatic cancer.