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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05721222
Other study ID # PRO1160-001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 15, 2023
Est. completion date April 30, 2025

Study information

Verified date February 2024
Source ProfoundBio US Co.
Contact ProfoundBio Trial Support
Phone 1-844-774-4232
Email clinicaltrialinfo@profoundbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Recruiting
Enrollment 134
Est. completion date April 30, 2025
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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 Design


Intervention

Drug:
PRO1160
Intravenous infusion of PRO1160

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
ProfoundBio US Co.

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type Measure Description Time frame Safety issue
Other Immunogenic potential of PRO1160 Assessment of anti-drug antibodies Through end of treatment, up to approximately 1 year
Primary Incidence of Treatment-Emergent Adverse Events Type, incidence, severity, and seriousness of adverse events Through end of treatment, up to approximately 1 year
Primary Dose limiting toxicity The proportion of patients experiencing dose limiting toxicities Through end of treatment, up to approximately 1 year
Secondary Objective Response Rate Patients who achieve partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL) Through end of treatment, up to approximately 1 year
Secondary Disease Control Rate Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria (RCC and NPC) and Lugano Classification 2014 (NHL) Through end of treatment, up to approximately 1 year
Secondary Progression-free survival Time from start of treatment to first documented disease progression or death Up to approximately 18 months
Secondary Duration of objective response Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death 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
Secondary Peak Plasma Concentration (Cmax) for PRO1160 Measurement of maximum plasma concentration after the administration of PRO1160 Through end of treatment, up to approximately 1 year
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