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

NCT05721222 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: PRO1160-001 (GCT1160-01)CTR20231732
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 17

Brief 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

Nasopharyngeal Carcinoma; Non Hodgkin Lymphoma; Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• Dose Escalation: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

  Up to approximately 1 year

• Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)

  28 days

• Expansion Parts A and B: Objective Response Rate (ORR)

  Up to approximately 1 year

Secondary Outcomes (13)

• Dose Escalation: ORR

  Up to approximately 1 year

• Dose Escalation: Disease Control Rate (DCR)

  Up to approximately 1 year

• Dose Escalation and Expansion Parts A and B: Progression-free Survival (PFS)

  Up to approximately 18 months

• Dose Escalation and Expansion Parts A and B: Duration of Objective Response (DOR)

  Up to approximately 1 year

• Dose Escalation and Expansion Parts A and B: Peak Plasma Concentration (Cmax) of GEN1160-related Analytes

  Up to approximately 1 year

Study Arms (1)

GEN1160

EXPERIMENTAL

GEN1160 monotherapy in escalating doses in the dose escalation part and at the recommended phase 2 dose in the expansion parts.

Biological: GEN1160

Interventions

GEN1160 BIOLOGICAL

IV infusion of GEN1160

Also known as: PRO1160

GEN1160

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Has pathological diagnosis of DLBCL, not otherwise specified (NOS) as defined by the World Health Organization (WHO) 2016 classification including both de novo or histologically transformed.
• Has relapsed or refractory disease with no available standard therapy or is not a candidate for available standard therapy, and for whom, in the opinion of the investigator, experimental therapy with GEN1160 may be beneficial. Participant must have received at least 2 systemic treatment regimens including CD20-containing chemoimmunotherapy.
• Has measurable disease according to the 2014 Lugano criteria (Cheson et al., 2014):
• A fluorodeoxyglucose (FDG)-positron emission tomography (PET) scan demonstrating positive lesion compatible with computed tomography (CT)- or MRI-defined anatomical tumor sites; AND
• A CT scan (or MRI) with involvement of ≥ 1 measurable nodal lesion (long axis \> 1.5 centimeters (cm) and short axis \> 1.0 cm) and/or ≥ 1 measurable extranodal lesion (long axis \> 1.0 cm).
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Has a fresh biopsy (if clinically feasible and not considered as a high-risk procedure) or an archival tumor biopsy and submit to the central laboratory for CD70 assay
• Has acceptable laboratory test results per protocol
• 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.

Sponsors & Collaborators

• Genmab: lead

Study Sites (17)

City of Hope Comprehensive Cancer Center - Duarte

Duarte, California, 91010, United States

Location

The City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Montefiore Medical Center - Montefiore Hospital

The Bronx, New York, 10467, United States

Location

Levine Cancer Center

Charlotte, North Carolina, 28204, United States

Location

Cleveland Clinic - Euclid Hospital

Cleveland, Ohio, 44195, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Sarah Cannon Research Institute - Nashville

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

START Mountain Cancer Center

West Valley City, Utah, 84119, United States

Location

Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Nasopharyngeal Carcinoma; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: March 15, 2023
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (14); CN (3)