Trial of PRO1160 (GEN1160) in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) (PRO1160-001)
NCT05721222 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2026-03-04
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.
Conditions
- Renal Cell Carcinoma
- Nasopharyngeal Carcinoma
- Non Hodgkin Lymphoma
Interventions
- BIOLOGICAL
-
GEN1160
IV infusion of GEN1160
Sponsors & Collaborators
-
Genmab
lead INDUSTRY
Principal Investigators
-
Study Official · Genmab
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-15
- Primary Completion
- 2025-11-05
- Completion
- 2025-11-05
- FDA Drug
- Yes
Countries
- United States
- China
Study Locations
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