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Trial record 1 of 1 for:    PRO1184
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PRO1184 for Advanced Solid Tumors (PRO1184-001)

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ClinicalTrials.gov Identifier: NCT05579366
Recruitment Status : Recruiting
First Posted : October 13, 2022
Last Update Posted : December 8, 2022
Sponsor:
Information provided by (Responsible Party):
ProfoundBio US Co.

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.


Condition or disease Intervention/treatment Phase
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 Drug: PRO1184 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of PRO1184 in Patients With Locally Advanced and/or Metastatic Solid Tumors
Actual Study Start Date : December 7, 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : September 2025


Arm Intervention/treatment
Experimental: PRO1184
PRO1184 monotherapy in escalating doses in Part A and at the recommended dose in Part B.
Drug: PRO1184
Intravenous infusion of PRO1184




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Through end of treatment, up to approximately 1 year. ]
    Type, incidence, severity, and seriousness of adverse events

  2. Dose limiting toxicity [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]
    The proportion of patients experiencing dose limiting toxicities


Secondary Outcome Measures :
  1. Best Overall Response [ Time Frame: Up to approximately 1 year. ]
    Best response per RECIST v1.1 criteria for all tumor types other than pleural mesothelioma which will use mRECIST v1.1

  2. Objective response rate [ Time Frame: Up to approximately 1 year. ]
    Patients who achieve partial or complete response per RECIST v1.1 criteria

  3. Disease control rate [ Time Frame: Up to approximately 1 year. ]
    Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria

  4. Progression-free survival [ Time Frame: Up to approximately 18 months. ]
    Time from start of treatment to first documented disease progression or death

  5. Overall survival [ Time Frame: Up to approximately 2 years. ]
    Time from the start of study treatment to the date of death from any cause

  6. Duration of objective response [ 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. ]
    Time from the first documentation of an objective tumor response (CR or PR) to the first documented tumor progression or death

  7. Peak Plasma Concentration (Cmax) for PRO1184 [ Time Frame: Through end of treatment, up to approximately 1 year. ]
    Measurement of maximum plasma concentration after the administration of PRO1184.

  8. Area under the plasma concentration versus time curve (AUC) for PRO1184 [ Time Frame: Through end of treatment, up to approximately 1 year. ]
    Measurement of AUC after the administration of PRO1184.


Other Outcome Measures:
  1. Immunogenic potential of PRO1184 [ Time Frame: Through end of treatment, up to approximately 1 year. ]
    Assessment of anti-drug antibodies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05579366


Contacts
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Contact: Linda Sluman, MD 847 922-4197 linda.sluman@precisionformedicine.com
Contact: ProfoundBio Trial Support PRO1184-001@profoundbio.com

Locations
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United States, Arizona
HonorHealth Not yet recruiting
Scottsdale, Arizona, United States, 85258
Contact: Muhammad R. Khawaja, MD, MPH    480-323-4637    mkhawaja@honorhealth.com   
United States, California
University of California Los Angeles Medical Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Gottfried Konecny, MD    310-500-8384    gkonecny@mednet.ucla.edu   
University of California, San Diego; Moores Cancer Center Not yet recruiting
San Diego, California, United States, 92093
Contact: Sandip Patel, MD    858-822-5182    spatel@health.ucsd.edu   
Providence Medical Foundation Recruiting
Santa Rosa, California, United States, 95403
Contact: Ian Anderson, MD    707-528-1050    ian.anderson@stjoe.org   
United States, Kansas
University of Kansas Medical Center (KUMC) Not yet recruiting
Westwood, Kansas, United States, 66205
Contact: Jun Zhang, MD, PhD    913-588-8150    jzhang3@kumc.edu   
United States, Michigan
Karmanos Cancer Institute Not yet recruiting
Detroit, Michigan, United States, 48085
Contact: Ira Winer, MD. PhD    313-576-9435    iwiner@med.wayne.edu   
United States, Oklahoma
University of Oklahoma - Health Sciences Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Debra Richardson, MD    214-645-4673    debra-richardson@ouhsc.edu   
United States, Tennessee
Sarah Cannon Research Institute at Tennessee Oncology Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact: Erika Hamilton, MD    615-320-5090    ehamilton@tnonc.com   
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75521
Contact: Douglas Orr, MD    972-566-3000    dorr@marycrowley.org   
United States, Utah
START Mountain Region Recruiting
West Valley City, Utah, United States, 84119
Contact: Justin Call, MD    801-907-4750    justin.call@startthecure.com   
Sponsors and Collaborators
ProfoundBio US Co.
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Responsible Party: ProfoundBio US Co.
ClinicalTrials.gov Identifier: NCT05579366    
Other Study ID Numbers: PRO1184-001
First Posted: October 13, 2022    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ProfoundBio US Co.:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Mesothelioma
Mesothelioma, Malignant
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Diseases