First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1047 in subjects with malignant solid tumors

Conditions

Malignant Solid Tumors

Brief summary

Dose Escalation Part: Dose-liming toxicities (DLTs), Dose Escalation Part: Adverse events (AEs) and safety laboratory parameters, Dose Expansion Part: Objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator

Detailed description

Dose Escalation Part: PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax; Tmax; Ctrough; and t1/2), Dose Escalation Part: Anti-drug antibody (ADA) incidence, Dose Escalation Part: Antitumor activity based on Response Evaluation Criteria in Solid Turmors (RECIST v1.1) as assessed by the investigator: Objective response rate (ORR), Duration of response (DOR), Time to response (TTR), Disease control rate (DCR), Dose Expansion Part: Antitumor activity, based on RECIST v1.1 as assessed by the investigator: DOR, TTR, DCR, Dose Expansion Part: Progression-free survival (PFS) based on RECIST v1.1 as assessed by the investigator; Overall Survival (OS), Dose Expansion Part: AEs and safety laboratory parameters, Dose Expansion Part: PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax; Tmax; Ctrough; t1/2), Dose Expansion Part: ADA response

Related papers

No related papers found yet.

Interventions

DRUGGEN1047 DP

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose Escalation Part: Dose-liming toxicities (DLTs), Dose Escalation Part: Adverse events (AEs) and safety laboratory parameters, Dose Expansion Part: Objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator	—

Secondary

Measure	Time frame
Dose Escalation Part: PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax; Tmax; Ctrough; and t1/2), Dose Escalation Part: Anti-drug antibody (ADA) incidence, Dose Escalation Part: Antitumor activity based on Response Evaluation Criteria in Solid Turmors (RECIST v1.1) as assessed by the investigator: Objective response rate (ORR), Duration of response (DOR), Time to response (TTR), Disease control rate (DCR), Dose Expansion Part: Antitumor activity, based on RECIST v1.1 as assessed by the investigator: DOR, TTR, DCR, Dose Expansion Part: Progression-free survival (PFS) based on RECIST v1.1 as assessed by the investigator; Overall Survival (OS), Dose Expansion Part: AEs and safety laboratory parameters, Dose Expansion Part: PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax; Tmax; Ctrough; t1/2), Dose Expansion Part: ADA response	—

Measure

Time frame

Dose Escalation Part: PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax; Tmax; Ctrough; and t1/2), Dose Escalation Part: Anti-drug antibody (ADA) incidence, Dose Escalation Part: Antitumor activity based on Response Evaluation Criteria in Solid Turmors (RECIST v1.1) as assessed by the investigator: Objective response rate (ORR), Duration of response (DOR), Time to response (TTR), Disease control rate (DCR), Dose Expansion Part: Antitumor activity, based on RECIST v1.1 as assessed by the investigator: DOR, TTR, DCR, Dose Expansion Part: Progression-free survival (PFS) based on RECIST v1.1 as assessed by the investigator; Overall Survival (OS), Dose Expansion Part: AEs and safety laboratory parameters, Dose Expansion Part: PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax; Tmax; Ctrough; t1/2), Dose Expansion Part: ADA response

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Countries

Belgium, Denmark, France, Italy, Netherlands, Poland, Spain

Outcome results

None listed