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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721222
• Other study ID #: PRO1160-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Lymphoma
• Lymphoma, Non-Hodgkin
• Nasopharyngeal Carcinoma
• Non Hodgkin Lymphoma
• Renal Cell Carcinoma

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