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


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).This is a Phase 1/2 study of PRO1160, a CD70 targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1160 in patients with selected locally advanced /or metastatic solid and liquid tumors, including renal cell carcinoma, nasophary

Trial Eligibility

Inclusion 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 Exclusion Criteria: * 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

Study Info

Organization

ProfoundBio US Co.


Primary Outcome

Incidence of Treatment-Emergent Adverse Events


Outcome Timeframe Through end of treatment, up to approximately 1 year

NCTID NCT05721222

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2023-03-15

Completion Date 2026-11-30

Enrollment Target 134

Interventions

DRUG PRO1160

Locations Recruiting

City of Hope Comprehensive Cancer Center - Duarte

United States, California, Duarte


The City of Hope Orange County Lennar Foundation Cancer Center

United States, California, Irvine


University of Michigan

United States, Michigan, Ann Arbor


Karmanos Cancer Institute

United States, Michigan, Detroit


Washington University School of Medicine in St. Louis

United States, Missouri, Saint Louis


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