Back to resultsPRO1184 for Advanced Solid Tumors (PRO1184-001)
Primary Purpose
Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PRO1184
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring antibody-drug conjugate, folate receptor alpha, folate receptor, solid tumor, ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer, endometrial cancer, non-small cell lung cancer, mesothelioma, breast cancer, triple negative breast cancer, HR+/HER2- breast cancer, topoisomerase I inhibitor, phase 1, ProfoundBio
Eligibility Criteria
Inclusion Criteria:
- histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer, breast cancer (hormone receptor positive, HER2-negative and triple-negative), mesothelioma
- previously received therapies known to confer clinical 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 all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline
- adequate hematologic, hepatic, renal and cardiac function
- for Part B, evidence of folate receptor alpha expression in tumor cells
Exclusion Criteria:
- 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
Sites / Locations
- University of California Los Angeles Medical Center
- University of California, San Diego; Moores Cancer Center
- Providence Medical FoundationRecruiting
- University of Kansas Medical Center (KUMC)Recruiting
- Massachusetts General HospitalRecruiting
- Dana Farber Cancer Institute
- Karmanos Cancer InstituteRecruiting
- University of Oklahoma - Health Sciences CenterRecruiting
- Sarah Cannon Research Institute at Tennessee OncologyRecruiting
- Mary Crowley Cancer ResearchRecruiting
- START Mountain RegionRecruiting
- Cancer hospital, Chinese Academy of Medical SciencesRecruiting
- Hunan Cancer Hospital - Phase 1
- Hunan Cancer Hospital - Thoracic Medicine Dept II
- Jilin Cancer Hospital
- Fudan University Shanghai Cancer Center- Gynecology Onc
- Fudan University Shanghai Cancer Center- Phase 1Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRO1184
Arm Description
PRO1184 monotherapy in escalating doses in Part A and at the recommended dose in Part B.
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Type, incidence, severity, and seriousness of adverse events
Dose limiting toxicity
The proportion of patients experiencing dose limiting toxicities
Secondary Outcome Measures
Best Overall Response
Best response per RECIST v1.1 criteria for all tumor types other than pleural mesothelioma which will use mRECIST v1.1
Objective response rate
Patients who achieve partial or complete response per RECIST v1.1 criteria
Disease control rate
Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria
Progression-free survival
Time from start of treatment to first documented disease progression or death
Overall survival
Time from the start of study treatment to the date of death from any cause
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
Peak Plasma Concentration (Cmax) for PRO1184
Measurement of maximum plasma concentration after the administration of PRO1184.
Area under the plasma concentration versus time curve (AUC) for PRO1184
Measurement of AUC after the administration of PRO1184.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05579366
Brief Title
PRO1184 for Advanced Solid Tumors
Acronym
PRO1184-001
Official Title
Phase 1/2 Study of PRO1184 in Patients With Locally Advanced and/or Metastatic Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProfoundBio US Co.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1184 in participants with solid tumors.
Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
This study will have two parts. Part A of the study will find out how much and how frequently PRO1184 should be given to participants. Part B will use the dose and schedule found in Part A to find out how safe PRO1184 is and if it works to treat solid tumor cancers.
Detailed Description
This is a Phase 1/2 study of PRO1184, a folate receptor alpha (FRα) targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1184 in patients with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma. 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 PRO1184 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Endometrial Cancer, Non-small Cell Lung Cancer, Mesothelioma, Triple Negative Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor-positive Breast Cancer
Keywords
antibody-drug conjugate, folate receptor alpha, folate receptor, solid tumor, ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer, endometrial cancer, non-small cell lung cancer, mesothelioma, breast cancer, triple negative breast cancer, HR+/HER2- breast cancer, topoisomerase I inhibitor, phase 1, ProfoundBio
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients will receive PRO1184 in ascending dose levels to establish a maximum tolerated dose, if reached, and the recommended Phase 2 dose, followed by dose expansion at selected dose and schedule.
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRO1184
Arm Type
Experimental
Arm Description
PRO1184 monotherapy in escalating doses in Part A and at the recommended dose in Part B.
Intervention Type
Drug
Intervention Name(s)
PRO1184
Intervention Description
Intravenous infusion of PRO1184
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Type, incidence, severity, and seriousness of adverse events
Time Frame
Through end of treatment, up to approximately 1 year.
Title
Dose limiting toxicity
Description
The proportion of patients experiencing dose limiting toxicities
Time Frame
At the end of Cycle 1 (each cycle is 21 days)
Secondary Outcome Measure Information:
Title
Best Overall Response
Description
Best response per RECIST v1.1 criteria for all tumor types other than pleural mesothelioma which will use mRECIST v1.1
Time Frame
Up to approximately 1 year.
Title
Objective response rate
Description
Patients who achieve partial or complete response per RECIST v1.1 criteria
Time Frame
Up to approximately 1 year.
Title
Disease control rate
Description
Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria
Time Frame
Up to approximately 1 year.
Title
Progression-free survival
Description
Time from start of treatment to first documented disease progression or death
Time Frame
Up to approximately 18 months.
Title
Overall survival
Description
Time from the start of study treatment to the date of death from any cause
Time Frame
Up to approximately 2 years.
Title
Duration of objective response
Description
Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death
Time Frame
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.
Title
Peak Plasma Concentration (Cmax) for PRO1184
Description
Measurement of maximum plasma concentration after the administration of PRO1184.
Time Frame
Through end of treatment, up to approximately 1 year.
Title
Area under the plasma concentration versus time curve (AUC) for PRO1184
Description
Measurement of AUC after the administration of PRO1184.
Time Frame
Through end of treatment, up to approximately 1 year.
Other Pre-specified Outcome Measures:
Title
Immunogenic potential of PRO1184
Description
Assessment of anti-drug antibodies
Time Frame
Through end of treatment, up to approximately 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer, breast cancer (hormone receptor positive, HER2-negative and triple-negative), mesothelioma
previously received therapies known to confer clinical 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 all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline
adequate hematologic, hepatic, renal and cardiac function
for Part B, evidence of folate receptor alpha expression in tumor cells
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ProfoundBio Trial Support
Phone
1-844-774-4232
Email
PRO1184-001@profoundbio.com
Facility Information:
Facility Name
University of California Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gottfried Konecny, MD
Phone
310-500-8384
Email
gkonecny@mednet.ucla.edu
Facility Name
University of California, San Diego; Moores Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandip Patel, MD
Phone
858-822-5182
Email
spatel@health.ucsd.edu
Facility Name
Providence Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Anderson, MD
Phone
707-528-1050
Email
ian.anderson@stjoe.org
Facility Name
University of Kansas Medical Center (KUMC)
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhang, MD, PhD
Phone
913-588-8150
Email
jzhang3@kumc.edu
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oladapo Yeku, MD
Phone
617-724-0287
Email
oyeku@mgh.harvard.edu
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Lee, MD
Phone
617-632-6287
Email
ElizabethK_Lee@DFCI.HARVARD.EDU
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ira Winer, MD. PhD
Phone
313-576-9435
Email
iwiner@med.wayne.edu
Facility Name
University of Oklahoma - Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Richardson, MD
Phone
214-645-4673
Email
debra-richardson@ouhsc.edu
Facility Name
Sarah Cannon Research Institute at Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Hamilton, MD
Phone
615-320-5090
Email
ehamilton@tnonc.com
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75521
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas Orr, MD
Phone
972-566-3000
Email
dorr@marycrowley.org
Facility Name
START Mountain Region
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Call, MD
Phone
801-907-4750
Email
justin.call@startthecure.com
Facility Name
Cancer hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Email
Lining@cicams.ac.cn
Facility Name
Hunan Cancer Hospital - Phase 1
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Wang, MD
Email
wangjing0081@126.com
Facility Name
Hunan Cancer Hospital - Thoracic Medicine Dept II
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Wu, MD
Email
wulin-calf@vip.163.com
Facility Name
Jilin Cancer Hospital
City
Chang chun
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng, MD
Email
jl.cheng@163.com
Facility Name
Fudan University Shanghai Cancer Center- Gynecology Onc
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua Wu, MD
Email
wu.xh@fudan.edu.cn
Facility Name
Fudan University Shanghai Cancer Center- Phase 1
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhang, MD
Email
syner20000@163.com
12. IPD Sharing Statement
Learn more about this trial
PRO1184 for Advanced Solid Tumors
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