PRO1184 for Advanced Solid Tumors (PRO1184-001)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05579366 |
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Recruitment Status :
Recruiting
First Posted : October 13, 2022
Last Update Posted : September 11, 2023
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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 |
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.
| 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 |
|---|---|
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Experimental: PRO1184
PRO1184 monotherapy in escalating doses in Part A and at the recommended dose in Part B.
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Drug: PRO1184
Intravenous infusion of PRO1184 |
- 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
- Dose limiting toxicity [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]The proportion of patients experiencing dose limiting toxicities
- 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
- Objective response rate [ Time Frame: Up to approximately 1 year. ]Patients who achieve partial or complete response per RECIST v1.1 criteria
- Disease control rate [ Time Frame: Up to approximately 1 year. ]Patients who achieve stable disease, partial or complete response per RECIST v1.1 criteria
- Progression-free survival [ Time Frame: Up to approximately 18 months. ]Time from start of treatment to first documented disease progression or death
- Overall survival [ Time Frame: Up to approximately 2 years. ]Time from the start of study treatment to the date of death from any cause
- 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
- 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.
- 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.
- Immunogenic potential of PRO1184 [ Time Frame: Through end of treatment, up to approximately 1 year. ]Assessment of anti-drug antibodies
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Contact: ProfoundBio Trial Support | 1-844-774-4232 | PRO1184-001@profoundbio.com |
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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: | September 11, 2023 |
| Last Verified: | September 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |
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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 Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms |