TERMINATED

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

Conditions

Renal Cell Carcinoma Nasopharyngeal Carcinoma Non Hodgkin Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2023-03-15

Study Completion:2025-11-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05721222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * Measurable disease at baseline: * Participants with RCC and NPC must have measurable disease as defined per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (Eisenhauer et al., 2009) * Participants with NHL must have measurable disease as defined by the Lugano Classification (Cheson et al., 2014) * Participants must be willing to provide a pre-treatment tumor specimen (archival or new tissue biopsy samples). If a new tissue biopsy is required, procedures more invasive than a core biopsy or significant risk procedures for which the procedure-associated absolute risk of mortality or major morbidity in the participant's clinical setting and specific institution is 2% or higher, should not be utilized.	* 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.

Inclusion Criteria

Exclusion 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
* Measurable disease at baseline:
* Participants with RCC and NPC must have measurable disease as defined per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (Eisenhauer et al., 2009)
* Participants with NHL must have measurable disease as defined by the Lugano Classification (Cheson et al., 2014)
* Participants must be willing to provide a pre-treatment tumor specimen (archival or new tissue biopsy samples). If a new tissue biopsy is required, procedures more invasive than a core biopsy or significant risk procedures for which the procedure-associated absolute risk of mortality or major morbidity in the participant's clinical setting and specific institution is 2% or higher, should not be utilized.

* 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.

Contacts and Locations

Principal Investigator

Study Official

STUDY_DIRECTOR

Genmab

Study Locations (Sites)

City of Hope Comprehensive Cancer Center - Duarte

Duarte, California, 91010

United States

The City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110

United States

NYU Langone Health

New York, New York, 10016

United States

Montefiore Medical Center - Montefiore Hospital

The Bronx, New York, 10467

United States

Levine Cancer Center

Charlotte, North Carolina, 28204

United States

Cleveland Clinic - Euclid Hospital

Cleveland, Ohio, 44195

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

Sarah Cannon Research Institute - Nashville

Nashville, Tennessee, 37203

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

START Mountain Cancer Center

West Valley City, Utah, 84119

United States

Collaborators and Investigators

Sponsor: Genmab

Study Official, STUDY_DIRECTOR, Genmab

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-15

Study Completion Date2025-11-05

Study Record Updates

Study Start Date2023-03-15

Study Completion Date2025-11-05

Terms related to this study

Additional Relevant MeSH Terms

Renal Cell Carcinoma
Nasopharyngeal Carcinoma
Non Hodgkin Lymphoma