RECRUITING

PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)

Description

Brief Summary: This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1160 in participants with solid tumors. Participants will have solid tumor or liquid cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This Phase 1/2 study will have two parts. Part A of the study will find out how much and how frequently PRO1160 should be given to participants. Part B will use the dose and schedule found in Part A to find out how safe PRO1160 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).

Study Overview

Study Details

Study overview

Brief Summary: This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1160 in participants with solid tumors. Participants will have solid tumor or liquid cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This Phase 1/2 study will have two parts. Part A of the study will find out how much and how frequently PRO1160 should be given to participants. Part B will use the dose and schedule found in Part A to find out how safe PRO1160 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).

Phase 1/2 Study of PRO1160 in Patients With Renal Cell Carcinoma (RCC), Nasopharyngeal Carcinoma (NPC), or Non-Hodgkin Lymphoma (NHL)

PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)

Condition
Renal Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Comprehensive Cancer Center - Duarte, Duarte, California, United States, 91010

Irvine

The City of Hope Orange County Lennar Foundation Cancer Center, Irvine, California, United States, 92618

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Saint Louis

Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States, 63110

Bronx

Montefiore Medical Center - Montefiore Hospital, Bronx, New York, United States, 10467

New York

NYU Langone Health, New York, New York, United States, 10016

Charlotte

Levine Cancer Center, Charlotte, North Carolina, United States, 28204

Cleveland

Cleveland Clinic - Euclid Hospital, Cleveland, Ohio, United States, 44195

Portland

Providence Portland Medical Center, Portland, Oregon, United States, 97213

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Pathologically confirmed metastatic or unresectable solid malignancy including Renal Cell carcinoma, Nasopharyngeal carcinoma or Stage III or IV Non Hodgkin Lymphoma
  • * Relapsed or refractory disease following prior systemic therapies known to confer medical benefit
  • * Willing to provide a tumor sample (archive tissue or fresh biopsy)
  • * ECOG performance status 0 or 1
  • * Measurable disease per RECIST v1.1 for RCC and NPC and per Lugano for NHL
  • * Prior treatment with anti-CD70 directed therapy
  • * Other malignancy within 3 years
  • * Active CNS metastases (treated, stable CNS metastases are allowed)
  • * Uncontrolled Grade 3 or greater infection within 2 weeks
  • * Positive for HBV, HCV or HIV
  • * Use of a strong P450 CYP3A inhibitor within 14 days (dose escalation only)
  • * Additional protocol defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ProfoundBio US Co.,

Study Record Dates

2027-03-30