First-in-Human, Open-Label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of GEN1078 in Subjects With Malignant Solid Tumors

Conditions

Malignant solid tumors

Brief summary

Dose Escalation: Number of Participants with Dose-limiting Toxicities (DLTs), Dose Escalation: Number of Participants with Adverse Events (AEs), Dose Expansion: Confirmed Objective Response Rate (ORR).

Detailed description

Dose-Escalation and Expansion: Clearance (CL) of GEN1078, Dose-Escalation and Expansion: Volume of Distribution (Vd) of GEN1078, Dose-Escalation and Expansion: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC0-last) of GEN1078, Dose-Escalation and Expansion: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) of GEN1078, Dose-Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax) of GEN1078, Dose-Escalation and Expansion: Time to Reach Cmax (Tmax) for GEN1078, Dose-Escalation and Expansion: Predose Concentration for GEN1078, Dose-Escalation and Expansion: Terminal Half-life (t½) of GEN1078, Dose-Escalation and Expansion: Number of Participants with Anti-drug Antibodies (ADAs), Dose Escalation: Confirmed ORR., Dose-Escalation and Expansion: Duration of Response (DOR)., Dose-Escalation and Expansion: Disease Control Rate (DCR)., Dose-Escalation and Expansion: Time to Response (TTR)., Dose Expansion: Number of Participants with AEs

Related papers

No related papers found yet.

Interventions

DRUGGEN1078 DP

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose Escalation: Number of Participants with Dose-limiting Toxicities (DLTs), Dose Escalation: Number of Participants with Adverse Events (AEs), Dose Expansion: Confirmed Objective Response Rate (ORR).	—

Secondary

Measure	Time frame
Dose-Escalation and Expansion: Clearance (CL) of GEN1078, Dose-Escalation and Expansion: Volume of Distribution (Vd) of GEN1078, Dose-Escalation and Expansion: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC0-last) of GEN1078, Dose-Escalation and Expansion: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) of GEN1078, Dose-Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax) of GEN1078, Dose-Escalation and Expansion: Time to Reach Cmax (Tmax) for GEN1078, Dose-Escalation and Expansion: Predose Concentration for GEN1078, Dose-Escalation and Expansion: Terminal Half-life (t½) of GEN1078, Dose-Escalation and Expansion: Number of Participants with Anti-drug Antibodies (ADAs), Dose Escalation: Confirmed ORR., Dose-Escalation and Expansion: Duration of Response (DOR)., Dose-Escalation and Expansion: Disease Control Rate (DCR)., Dose-Escalation and Expansion: Time to Response (TTR)., Dose Expansion: Num	—

Measure

Time frame

Dose-Escalation and Expansion: Clearance (CL) of GEN1078, Dose-Escalation and Expansion: Volume of Distribution (Vd) of GEN1078, Dose-Escalation and Expansion: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC0-last) of GEN1078, Dose-Escalation and Expansion: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) of GEN1078, Dose-Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax) of GEN1078, Dose-Escalation and Expansion: Time to Reach Cmax (Tmax) for GEN1078, Dose-Escalation and Expansion: Predose Concentration for GEN1078, Dose-Escalation and Expansion: Terminal Half-life (t½) of GEN1078, Dose-Escalation and Expansion: Number of Participants with Anti-drug Antibodies (ADAs), Dose Escalation: Confirmed ORR., Dose-Escalation and Expansion: Duration of Response (DOR)., Dose-Escalation and Expansion: Disease Control Rate (DCR)., Dose-Escalation and Expansion: Time to Response (TTR)., Dose Expansion: Num

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Countries

Denmark, Spain

Outcome results

None listed