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Trial of PRO1160 (GEN1160) in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) (PRO1160-001) | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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)

NCT05721222•Genmab

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All participants must have pathologically confirmed diagnosis of one of the following tumor types:
•* Metastatic RCC, including clear cell renal cell carcinoma (ccRCC) or papillary RCC
•* Metastatic or relapsed Epstein Barr virus (EBV)-associated NPC not amenable to further local therapies (EBV association may have been determined by testing on tumor tissue or peripheral blood)
•* Advanced (Stage III or IV) NHL, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) requiring systemic therapy, and mantle cell lymphoma (MCL)
•Participants must have relapsed or refractory disease following prior systemic therapies known to confer clinical benefit. At minimum, participants should have received the following therapies (unless deemed ineligible, refused by the participant, or not available in the region):
•* Participants with RCC must have received a minimum of one prior treatment regimen, and have received a tyrosine kinase inhibitor (TKI) and a programmed cell death (ligand) (\[PD\[L)\])-1 inhibitor
•* Participants with EBV-associated NPC must have received a minimum of one prior treatment regimen, which must include a platinum-based chemotherapy regimen
•* Participants with DLBCL must have received a minimum of 2 prior treatment regimens, including a multi-agent chemoimmunotherapy regimen given with curative intent (eg, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone \[R-CHOP\]), and participants must have received intensive salvage chemotherapy with hematopoietic stem cell transplant (HSCT) if considered eligible by the investigator
•* Participants with FL must have received a minimum of 2 prior treatment regimens, which must include a multi-agent chemoimmunotherapy regimen including an anti-CD20 agent
•* Participants with mantle cell lymphoma (MCL) must have received a minimum of 2 prior treatment regimens, which must include a multi-agent chemoimmunotherapy regimen including an anti-CD20 agent
+12 more criteria

Exclusion Criteria

•Prior treatment with anti-CD70 directed therapy
•Prior therapy with an antibody-drug conjugate (ADC) with a topoisomerase 1 inhibitor payload
•Prior allogeneic hematopoietic stem cell transplant (HSCT). Participants with prior autologous HSCT must have completed the procedure at least 100 days prior to the first dose of study drug.
•Known active central nervous system metastases, including carcinomatous meningitis. Participants with brain metastases may participate provided the metastases have been treated and are stable for at least 4 weeks prior to the first dose of study drug, they have no new or enlarging brain metastases and have discontinued corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with a history of brain metastases, suspected new brain metastases, or a diagnosis of RCC should have a magnetic resonance imaging (MRI) of the brain at screening.
•Primary central nervous system (CNS) tumor or known CNS involvement.
•Has been exposed to any of the following prior therapies within the specified timeframes:
•* Received prior investigational CD70-targeting therapy, eg, CD70-directed chimeric antigen receptor T-cell (CAR-T) therapy, anti-CD70 monoclonal antibody (mAb), CD3 x CD70 bispecific monoclonal antibody (bsAb), or CD70 antibody-drug conjugate.
•* Autologous stem cell transplant within 60 days prior to the first dose of GEN1160.
•* Allogeneic stem cell transplant within 90 days prior to the first dose of GEN1160.
•* Chemotherapy within 2 weeks or major surgery within 4 weeks of the first dose of GEN1160.
+11 more criteria

Locations (17)

City of Hope Comprehensive Cancer Center - Duarte

Duarte, California, United States

The City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

University of Michigan

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

NYU Langone Health

New York, New York, United States

Montefiore Medical Center - Montefiore Hospital

The Bronx, New York, United States

Levine Cancer Center

Charlotte, North Carolina, United States

Cleveland Clinic - Euclid Hospital

Cleveland, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

Key Dates

Start Date

March 15, 2023

Primary Completion Date

November 5, 2025

Completion Date

November 5, 2025

Last Updated

March 4, 2026

Enrollment

ACTUAL participants

Conditions

Renal Cell CarcinomaNasopharyngeal CarcinomaNon Hodgkin Lymphoma

Interventions

GEN1160

BIOLOGICAL

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

NCT06980038

Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell Carcinoma+20 more

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RECRUITING

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)