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

Phase 1

Recruiting

Conditions: Renal Cell Carcinoma
Nasopharyngeal Carcinoma
Non Hodgkin Lymphoma

Brief Summary: 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).

Detailed Description: 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, nasopharyngeal carcinoma and non-hodgkin lymphoma. This study consists of 2 parts, Part A: Dose Escalation and Part B: Dose Expansion.

Part A may evaluate up to 7 dose levels of PRO1160 on Day 1 of a 21 day cycle by IV infusion.

Part B will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical PK, PD and activity data from Part A in up to 4 different cohorts of up to 20 patients per cohort.

Patients will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
PRO1160	PRO1160	PRO1160 monotherapy in escalating doses in Part A and at the recommended phase 2 dose in Part B

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	Through end of treatment, up to approximately 1 year	Type, incidence, severity, and seriousness of adverse events
Dose limiting toxicity	Through end of treatment, up to approximately 1 year	The proportion of patients experiencing dose limiting toxicities

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate	Through end of treatment, up to approximately 1 year	Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)
Duration of objective response	From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months	Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death
Objective Response Rate	Through end of treatment, up to approximately 1 year	Patients who achieve partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL)
Peak Plasma Concentration (Cmax) for PRO1160	Through end of treatment, up to approximately 1 year	Measurement of maximum plasma concentration after the administration of PRO1160
Progression-free survival	Up to approximately 18 months	Time from start of treatment to first documented disease progression or death

Locations (17): Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳
Shanghai, Shanghai, China
City of Hope Comprehensive Cancer Center - Duarte
🇺🇸
Duarte, California, United States
Washington University School of Medicine in St. Louis
🇺🇸
Saint Louis, Missouri, United States
NYU Langone Health
🇺🇸
New York, New York, United States
Levine Cancer Center
🇺🇸
Charlotte, North Carolina, United States
Cleveland Clinic - Euclid Hospital
🇺🇸
Cleveland, Ohio, United States
Cancer Hospital of Chinese Academy of Medical Sciences
🇨🇳
Beijing, Beijing, China
Fudan University Shanghai Cancer Center
🇨🇳
Shanghai, Shanghai, China
START Mountain Cancer Center
🇺🇸
West Valley City, Utah, United States
The City of Hope Orange County Lennar Foundation Cancer Center
🇺🇸
Irvine, California, United States
MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
🇺🇸
Detroit, Michigan, United States
Providence Portland Medical Center
🇺🇸
Portland, Oregon, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
Sarah Cannon Research Institute - Nashville
🇺🇸
Nashville, Tennessee, United States
Montefiore Medical Center - Montefiore Hospital
🇺🇸
Bronx, New York, United States