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)

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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

Locations
United States
California
City of Hope Comprehensive Cancer Center - Duarte
RECRUITING
Duarte
The City of Hope Orange County Lennar Foundation Cancer Center
RECRUITING
Irvine
Michigan
University of Michigan
ACTIVE_NOT_RECRUITING
Ann Arbor
Karmanos Cancer Institute
COMPLETED
Detroit
Missouri
Washington University School of Medicine in St. Louis
COMPLETED
St Louis
North Carolina
Levine Cancer Center
ACTIVE_NOT_RECRUITING
Charlotte
New York
NYU Langone Health
RECRUITING
New York
Montefiore Medical Center - Montefiore Hospital
ACTIVE_NOT_RECRUITING
The Bronx
Ohio
Cleveland Clinic - Euclid Hospital
ACTIVE_NOT_RECRUITING
Cleveland
Oregon
Oregon Health & Science University
RECRUITING
Portland
Providence Portland Medical Center
ACTIVE_NOT_RECRUITING
Portland
Tennessee
Sarah Cannon Research Institute - Nashville
RECRUITING
Nashville
Texas
MD Anderson Cancer Center
ACTIVE_NOT_RECRUITING
Houston
Utah
START Mountain Cancer Center
ACTIVE_NOT_RECRUITING
West Valley City
Other Locations
China
Cancer Hospital of Chinese Academy of Medical Sciences
ACTIVE_NOT_RECRUITING
Beijing
Fudan University Shanghai Cancer Center
ACTIVE_NOT_RECRUITING
Shanghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
ACTIVE_NOT_RECRUITING
Shanghai
Contact Information
Primary
Genmab Trial Information
clinicaltrials@genmab.com
+4570202728
Time Frame
Start Date: 2023-03-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 110
Treatments
Experimental: GEN1160
GEN1160 monotherapy in escalating doses in the dose escalation part and at the recommended phase 2 dose in the expansion parts.
Sponsors
Leads: Genmab

This content was sourced from clinicaltrials.gov