NCT05721222

Trial of PRO1160 (GEN1160) in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) (PRO1160-001)

Phase 1/2 Study of PRO1160 in Patients With Metastatic Renal Cell Carcinoma (RCC), Metastatic or Relapsed Nasopharyngeal Carcinoma (NPC), or Advanced (Stage III or IV) Non-Hodgkin Lymphoma (NHL)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Brief Summary: This study will test the safety, including side effects, and determine the characteristics of a drug called GEN1160 (PRO1160) in participants with solid tumors and blood cancers. Participants will have cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable) or relapsed or refractory to prior treatments. This Phase 1/2 study will have three parts. The dose escalation part of the study will find out how much and how frequently GEN1160 should be given to participants. The expansion Part A and expansion Part B will use the dose and schedule found in the dose escalation part to find out how safe GEN1160 is and if it works to treat the diseases under study. The diseases under study will be Renal Cell Carcinoma (RCC), Nasopharyngeal Carcinoma (NPC) and Non-Hodgkin Lymphoma (NHL) in Escalation and diffuse large B-cell lymphoma (DLBCL) in expansion Part A and Part B.

Detailed description

This is a Phase 1/2 study of GEN1160, a CD70 targeted antibody-drug conjugate, to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of GEN1160 in participants with selected locally advanced /or metastatic solid and hematologic malignancies, including RCC, NPC and NHL. This study consists of 3 parts, Dose Escalation, Expansion Part A and Expansion Part B. Dose escalation may evaluate up to 5 dose levels of GEN1160 on Day 1 of a 21 day cycle by intravenous (IV) infusion. Expansion will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical PK, pharmacodynamics (PD) and activity data from the dose escalation. Expansion will be conducted in 1 cohort of up to 10 participants (expansion Part A) and 2 further cohorts (expansion Part B), each with up to 25 participants per cohort. Participants will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, initiation of non-GEN1160 anticancer therapy, participant noncompliance, pregnancy, or death.

Conditions

• Renal Cell Carcinoma
• Nasopharyngeal Carcinoma
• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	GEN1160	IV infusion of GEN1160

Timeline

• Start date: 2023-03-15
• Primary completion: 2025-11-05
• Completion: 2025-11-05
• First posted: 2023-02-09
• Last updated: 2026-03-04

Locations

17 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study