Trial Title:
PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001)
NCT ID:
NCT05721222
Condition:
Renal Cell Carcinoma
Nasopharyngeal Carcinoma
Non Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Carcinoma
Lymphoma, Non-Hodgkin
Carcinoma, Renal Cell
Nasopharyngeal Carcinoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PRO1160
Description:
Intravenous infusion of PRO1160
Arm group label:
PRO1160
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Comprehensive Cancer Center - Duarte
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
The City of Hope Orange County Lennar Foundation Cancer Center
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine in St. Louis
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Montefiore Medical Center - Montefiore Hospital
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
Levine Cancer Center
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic - Euclid Hospital
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Facility:
Name:
Oregon Health & Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute - Nashville
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
START Mountain Cancer Center
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer Hospital of Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Facility:
Name:
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Start date:
March 15, 2023
Completion date:
March 30, 2027
Lead sponsor:
Agency:
ProfoundBio US Co.
Agency class:
Industry
Source:
ProfoundBio US Co.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05721222
