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Trial of PRO1160 (GEN1160) in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) (PRO1160-001)
Trial Status: active
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.
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
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. Dose Escalation Key
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. Expansion: Key
Additional locations may be listed on ClinicalTrials.gov for NCT05721222.