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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 : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
ProfoundBio US Co.

Study Description
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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).


Condition or disease Intervention/treatment Phase
Ovarian Cancer High Grade Epithelial Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Endometrial Cancer Non-small Cell Lung Cancer Mesothelioma Breast Adenocarcinoma Triple Negative Breast Cancer Hormone Receptor-positive/Her2 Negative Breast Cancer Drug: PRO1184 Drug: PRO1184 intravenous infusion of 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.

The study consists of 4 main parts:

Part A: dose-escalation cohorts

Part B: tumor-specific monotherapy dose-expansion cohorts

Part C: ovarian cancer extension cohort

Part D: combination therapy cohorts

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 374 participants
Allocation: Non-Randomized
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 : October 2025
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A, B, C
PRO1184 monotherapy in escalating doses in Part A and at the recommended dose in Part B and C.
 Drug: PRO1184
Intravenous infusion of PRO1184
Experimental: Part D1
PRO1184 in combination with carboplatin
 Drug: PRO1184 intravenous infusion of PRO1184
Carboplatin intravenous infusion
Experimental: Part D2
PRO1184 in combination with bevacizumab
 Drug: PRO1184 intravenous infusion of PRO1184
Bevacizumab intravenous infusion
Experimental: Part D3
PRO1184 in combination with pembrolizumab
 Drug: PRO1184 intravenous infusion of PRO1184
Pembrolizumab intravenous infusion


Outcome Measures
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Primary Outcome Measures :
  1. Parts A, B, and D - 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. Parts A, B, and D - Dose limiting toxicity [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]
    The proportion of patients experiencing dose limiting toxicities

  3. Parts A, B, and D - Type, incidence, and severity of laboratory abnormalities [ Time Frame: Through end of treatment, up to approximately 1 year. ]
  4. Part C - ORR per RECIST v1.1 [ Time Frame: Through end of treatment, up to approximately 1 year. ]

Secondary Outcome Measures :
  1. Parts A, B, and D - 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. Parts A, B, and D - Objective response rate [ Time Frame: Up to approximately 1 year. ]
    Patients who achieve partial or complete response per RECIST v1.1 criteria

  3. Parts A, B, and D - 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. Parts A, B, C, and D - Progression-free survival [ Time Frame: Through end of treatment, up to approximately 1 year. ]
    Time from start of treatment to first documented disease progression or death

  5. Part C - 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. Parts A, B, C, and D - 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. Parts A, B, and D - 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. Parts A, B, and D - 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.

  9. Parts C and D - CA-125 response determined using the Gynecologic Cancer Intergroup (GCIG) criteria [ Time Frame: Through end of treatment, up to approximately 1 year. ]
  10. Part C - Type, incidence, severity, seriousness as per CTCAE v5.0, and relatedness of adverse events [ Time Frame: Through end of treatment, up to approximately 1 year. ]
  11. Part C - Type, incidence, and severity of laboratory abnormalities [ Time Frame: Through end of treatment, up to approximately 1 year. ]

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

  2. Parts A and B - Overall survival [ Time Frame: Up to approximately 2 years. ]
    Time from the start of study treatment to the date of death from any cause

  3. Parts A, B, C, and D - Exploratory biomarkers of PRO1184-mediated and disease-related pharmacodynamic effects [ Time Frame: Through end of treatment, up to approximately 1 year. ]
  4. Part C - 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.

  5. Part C - 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.


Eligibility Criteria
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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

Part C:

High grade ovarian cancer:

  • Patients must have platinum-resistant/refractory ovarian cancer
  • Patients must have received prior bevacizumab
  • Patients with known or suspected deleterious germline or somatic BRCA mutations must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor
  • Patients must have previously received mirvetuximab soravtansine, if indicated based on an FDA approved test for FRα expression (i.e., FRα PS2+ membrane expression in at least 75% of tumor cells), unless the patient has a documented medical exception
  • Prior induction plus maintenance is considered 1 line of therapy, even if parts of the treatment regimen (induction or maintenance) are interrupted and/or resumed at a later date, in the absence of disease progression while on active treatment
  • A switch/change in regimen due solely to toxicity or patient preference (and not disease progression) is not considered a separate line of therapy

Part D:

Cohort D1 (PRO1184+carboplatin):

  • Patients must have platinum-sensitive ovarian cancer
  • Patients must have received 1 to 3 prior lines of therapy

Cohort D2 (PRO1184+bevacizumab):

-Patients must have platinum-resistant/refractory ovarian cancer

Cohort D3 (PRO1184+pembrolizumab):

  • Endometrial cancer (any subtype excluding sarcoma)
  • Patients must have received prior platinum-based chemotherapy for recurrent or advanced disease

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 CYP3A inhibitor within 14 days (dose escalation only)
  • prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate
  • additional protocol defined inclusion/exclusion criteria may apply
Contacts and Locations
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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: ProfoundBio Trial Support 1-844-774-4232 PRO1184-001@profoundbio.com

Locations
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Sponsors and Collaborators
ProfoundBio US Co.
More Information
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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: May 3, 2024
Last Verified: April 2024

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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
Carcinoma, Ovarian Epithelial
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Mesothelioma
Mesothelioma, Malignant
Fallopian Tube Neoplasms
Carcinoma
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 Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases