A Phase 1/2a, Open-label, Dose Escalation Trial of GEN3017 with Expansion Cohorts in Relapsed or Refractory CD30+ Classical Hodgkin Lymphoma and CD30+ Non-Hodgkin Lymphoma

Conditions

Hodgkin lymphoma or non-Hodgkin lymphoma

Brief summary

Dose Escalation: Incidence of dose-limiting toxicities (DLTs), Incidence and severity of adverse events (AEs), Expansion: ORR based on the Lugano criteria as assessed by independent review committee (IRC)

Detailed description

Dose Escalation: Noncompartmental PK parameters: • Maximum concentration (Cmax) • Time to Cmax (tmax) • Predose trough concentration (Ctrough) • Area under the concentration-time curve from time 0 to last quantifiable sample (AUClast) and from time 0 to infinity (AUCinf) • Elimination half-life (T1/2) • Clearance • Volume of distribution, Dose Escalation: Anti-GEN3017 antibodies, Dose Escalation: Anti-tumor activity based on the Lugano criteria as assessed by investigator: • Objective response rate (ORR) • Duration of response (DOR) • Time to response (TTR), Expansion: Anti-tumor activity based on the Lugano criteria as assessed by IRC and investigator: • ORR (investigator only) • CR (complete response) rate • DOR • TTR • PFS (progression-free survival) • OS (overall survival), Expansion: • Safety: Incidence and severity of AEs and serious adverse events (SAEs) • Immunogenicity: Anti-GEN3017 antibodies, Expansion: PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax; Tmax; Ctrough; and t1/2)

Related papers

No related papers found yet.

Interventions

DRUGPREDNISOLONE

DRUGPARACETAMOL

DRUGSILTUXIMAB

DRUGANAKINRA

DRUGDIPHENHYDRAMINE

DRUGTOCILIZUMAB

DRUGDuoBody-CD3xCD30

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose Escalation: Incidence of dose-limiting toxicities (DLTs), Incidence and severity of adverse events (AEs), Expansion: ORR based on the Lugano criteria as assessed by independent review committee (IRC)	—

Secondary

Measure	Time frame
Dose Escalation: Noncompartmental PK parameters: • Maximum concentration (Cmax) • Time to Cmax (tmax) • Predose trough concentration (Ctrough) • Area under the concentration-time curve from time 0 to last quantifiable sample (AUClast) and from time 0 to infinity (AUCinf) • Elimination half-life (T1/2) • Clearance • Volume of distribution, Dose Escalation: Anti-GEN3017 antibodies, Dose Escalation: Anti-tumor activity based on the Lugano criteria as assessed by investigator: • Objective response rate (ORR) • Duration of response (DOR) • Time to response (TTR), Expansion: Anti-tumor activity based on the Lugano criteria as assessed by IRC and investigator: • ORR (investigator only) • CR (complete response) rate • DOR • TTR • PFS (progression-free survival) • OS (overall survival), Expansion: • Safety: Incidence and severity of AEs and serious adverse events (SAEs) • Immunogenicity: Anti-GEN3017 antibodies, Expansion: PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax;	—

Measure

Time frame

Dose Escalation: Noncompartmental PK parameters: • Maximum concentration (Cmax) • Time to Cmax (tmax) • Predose trough concentration (Ctrough) • Area under the concentration-time curve from time 0 to last quantifiable sample (AUClast) and from time 0 to infinity (AUCinf) • Elimination half-life (T1/2) • Clearance • Volume of distribution, Dose Escalation: Anti-GEN3017 antibodies, Dose Escalation: Anti-tumor activity based on the Lugano criteria as assessed by investigator: • Objective response rate (ORR) • Duration of response (DOR) • Time to response (TTR), Expansion: Anti-tumor activity based on the Lugano criteria as assessed by IRC and investigator: • ORR (investigator only) • CR (complete response) rate • DOR • TTR • PFS (progression-free survival) • OS (overall survival), Expansion: • Safety: Incidence and severity of AEs and serious adverse events (SAEs) • Immunogenicity: Anti-GEN3017 antibodies, Expansion: PK parameters (clearance; volume of distribution; AUClast; AUCinf; Cmax;

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Countries

Denmark, France, Germany, Italy, Netherlands

Outcome results

None listed