Clinical trial NCT05721222: PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)
Official title: Phase 1/2 Study of PRO1160 in Patients With Renal Cell Carcinoma (RCC), Nasopharyngeal Carcinoma (NPC), or Non-Hodgkin Lymphoma (NHL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Renal Cell Carcinoma
Nasopharyngeal Carcinoma
Non Hodgkin Lymphoma
Lead sponsor: ProfoundBio US Co.
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Through end of treatment, up to approximately 1 year
measure: Dose limiting toxicity
timeFrame: Through end of treatment, up to approximately 1 year
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Through end of treatment, up to approximately 1 year
measure: Disease Control Rate
timeFrame: Through end of treatment, up to approximately 1 year
measure: Progression-free survival
timeFrame: Up to approximately 18 months
measure: Duration of objective response
timeFrame: 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
measure: Peak Plasma Concentration (Cmax) for PRO1160
timeFrame: Through end of treatment, up to approximately 1 year
Other outcomes:
measure: Immunogenic potential of PRO1160
timeFrame: Through end of treatment, up to approximately 1 year
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center - Duarte
state: California
city: Irvine
country: United States
facility: The City of Hope Orange County Lennar Foundation Cancer Center
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center - Montefiore Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic - Euclid Hospital
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Nashville
country: United States
facility: Sarah Cannon Research Institute - Nashville
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: West Valley City
country: United States
facility: START Mountain Cancer Center
state: Utah
city: Beijing
country: China
facility: Cancer Hospital of Chinese Academy of Medical Sciences
state: Beijing
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: