search
Back to results

Testing the Addition of Immunotherapy With Hu5F9-G4 (Magrolimab) to the Usual PARP Inhibitor, Olaparib for Treatment of Metastatic or Recurrent Breast or Castrate-Resistant Prostate Cancer With BRCA Mutations

Primary Purpose

Anatomic Stage IV Breast Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biopsy
Biospecimen Collection
Computed Tomography
Magnetic Resonance Imaging
Magrolimab
Olaparib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anatomic Stage IV Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Presence of metastatic and/or recurrent solid tumors (therapy naïve or those with prior therapy) with pathogenic BRCA 1/2 mutated cancers where olaparib is indicated as standard of care therapeutic option (not maintenance) as below: Metastatic breast cancer: Germline - Yes (Y); Somatic - No (N): Must have had prior chemotherapy (chemo) (adjuvant [adj], treatment); or if hormone receptor positive (HR+), must have had prior endocrine therapy or deemed inappropriate for endocrine treatment Metastatic castrate-resistant prostate cancer (CPRC) Germline - Y; Somatic - Y: Treatment after progressive disease on anti-androgens BRCA mutation status must be confirmed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory (lab) Patients >= 18 years of age. Because no dosing or adverse event data are currently available on the use of Hu5F9-G4 (magrolimab) in combination with olaparib in patients < 18 years of age, children are excluded from this study Patients may not have had prior PARP inhibitor in the metastatic setting when given for therapeutic purposes. Patients with breast cancer who received adjuvant PARP inhibitor (i) are eligible. Patients who had prior maintenance therapy are eligible. At least 4 weeks or 4 prior drug half-lives (whichever is shorter) must have elapsed since completion of the previous systemic therapy Expansion Cohort: Willingness and feasibility to undergo pre and post treatment biopsy Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Absolute neutrophil count >= 1,500/mcL Platelets >= 100,000/mcL Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN Glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2 Hemoglobin (Hgb) >= 9 g/dL Patients infected with human immunodeficiency virus (HIV) who are on effective anti-retroviral therapy with undetectable viral load within 6 months may be eligible for this trial For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients with prior brain metastasis that was treated with evidence of resolution or stable disease for 6 months are eligible. Patients are required to be stable and fully tapered off steroids for at least >= 1 month Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better Women of child-bearing potential, and men who are sexually active and their partner who may become pregnant, must use contraception during treatment and at least for 6 months (women) and 4 months (men) after the last dose of magrolimab and olaparib. Breastfeeding is not allowed during treatment and for one month after receiving the last dose of therapy Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Exclusion Criteria: Previous anti-CD47 therapy Concomitant use of strong CYP3A4 inhibitors/inducers can cause clinically significant drug-interactions; thus, study patients who require the use of these CYP enzymes continuously should be excluded. Study patients need to come off 3 eliminated half-lives of moderate CYP3A4 inhibitors and 5 eliminated half-lives of strong CYP3A4 inhibitors Patients who require immunosuppressive treatments for comorbidities are not eligible Gastrointestinal pathology or history that adversely impacts the ability to take or absorb oral medication Inability to comply with the protocol and/or not willing or who will not be available for follow-up assessments Patients who are receiving any other investigational agents History of allergic reactions attributed to compounds of similar chemical or biologic composition to magrolimab or other agents used in study Patients with uncontrolled intercurrent illness Pregnant women are excluded from this study because Hu5F9-G4 (magrolimab) is an anti-CD47 monoclonal antibody agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Hu5F9-G4 (magrolimab), breastfeeding should be discontinued if the mother is treated with Hu5F9-G4 (magrolimab). These potential risks may also apply to other agents used in this study

Sites / Locations

  • University of Pittsburgh Cancer Institute (UPCI)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (magrolimab, olaparib)

Arm Description

Patients receive magrolimab IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of subsequent cycles. Patients also receive olaparib PO BID during each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and CT and/or MRI throughout the trial. Patients in the dose-expansion portion of the study also undergo tumor biopsies during screening and on study.

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD) of olaparib with magrolimab (Dose Escalation)
The MTD is defined as the highest dose level with no more than 1/6 dose-limiting toxicities (DLT). DLT is defined as any grade >= 3 non-hematologic toxicity despite best supportive care or grade >= 4 hematologic toxicity per Common Terminology Criteria for Adverse Events version 5.0 attributed as possibly, probably, or definitely related to study drugs during the first cycle of therapy (28 days) lasting more than 7 days.
Tumor ribonucleic acid (RNA) sequencing of interferon- gamma (IFN-g) signature, TGF-beta signature, and STING pathway, as well as CD47 expression (Dose Expansion)
Will be compared between tumor tissue using a non-parametric paired test, at a significance level (alpha) of 0.05. This will only be performed in the expansion cohorts.
Tumor macrophage infiltrate (Dose Expansion)
Will be assessed using multiplex immune imaging and their phenotype (M1/M2 ratio) as well as STING pathway activation (TBK1, IRF3 and IFNB protein expression). Will be compared between tumor tissue using a non-parametric paired test, at a significance level (alpha) of 0.05. This will only be performed in the expansion cohorts.
Tumor infiltrating immune cells (Dose Expansion)
Will be assessed using multiplex immune imaging. Will be compared between tumor tissue using a non-parametric paired test, at a significance level (alpha) of 0.05. This will only be performed in the expansion cohorts.
Recommended phase 2 dose (Dose Expansion)
The RP2D determination will include both the DLT period for the MTD, as well as consideration of later cycle DLTs and the overall safety profile..
Incidence of adverse events (Dose Expansion)
Adverse events will be scored by CTCAE v5.0 and tabulated.

Secondary Outcome Measures

Tumor genomic markers
Deoxyribonucleic acid (DNA) damage response (DDR) genes including BRCA 1, 2 and other genes such as RAD51C, RAD51D, and PALB, polymorphism status, mutational burden and microsatellite instability (MSI) status will be assessed in available pre-treatment tissue and correlated with immune response by whole exome sequencing.
Olaparib and magrolimab trough and potentially area under the curve
Descriptive data will be reported and compared with historical controls.

Full Information

First Posted
April 8, 2023
Last Updated
September 29, 2023
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05807126
Brief Title
Testing the Addition of Immunotherapy With Hu5F9-G4 (Magrolimab) to the Usual PARP Inhibitor, Olaparib for Treatment of Metastatic or Recurrent Breast or Castrate-Resistant Prostate Cancer With BRCA Mutations
Official Title
A Phase I/Ib Study of Anti-CD47 Hu5F9-G4 (Magrolimab) in Combination With Olaparib in Patients With BRCA1/2-Mutant Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2023 (Anticipated)
Primary Completion Date
December 6, 2026 (Anticipated)
Study Completion Date
December 6, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase I/Ib trial studies the side effects and best dose of Hu5F9-G4 (magrolimab) when given in combination with olaparib for the treatment of patients with breast or castrate-resistant prostate cancer that have spread from where they first started (primary site) to other places in the body (metastatic) or have come back after a period of improvement (recurrent) and have mutations in the BRCA1/2 genes. Magrolimab is a monoclonal antibody with potential anticancer activity and the cability to stimulate the immune system and may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Combination therapy with magrolimab and olaparib may be safe and effective in treating BRCA-mutated metastatic or recurrent breast or castrate-resistant prostate cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the safety, tolerability, toxicity profile (dose-limiting toxicities [DLTs], maximum tolerated doses [MTDs]), and phase 2 recommended dose (P2RD) of Hu5F9-G4 (magrolimab) combined with olaparib. II. To evaluate the alteration in the immune microenvironment after combination therapy including alteration of specific immune signatures and pathways related to innate immune response and STING pathway. (Dose expansion) SECONDARY OBJECTIVES: I. To evaluate the status of homologous recombination repair (HR)/DNA damage response (DDR) and other genomic mutations. II. To characterize the pharmacokinetic (PK) profile of olaparib and magrolimab in combination. EXPLORATORY OBJECTIVES: I. To explore the activity of the combination regimen in entire cohort and in the dose expansion cohorts in term of objective response rate (ORR), and progression-free survival (PFS). II. To evaluate the peripheral immune profile. III. To evaluate alterations in the HR/DDR pathway by circulating tumor (ct)DNA. IV. To correlate drug exposure with response and/or toxicity. OUTLINE: This is a dose-escalation study of magrolimab in combination with fixed-dose Olaparib followed by a dose-expansion study. Patients receive magrolimab intravenously (IV) on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of subsequent cycles. Patients also receive olaparib orally (PO) twice a day (BID) during each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the trial. Patients in the dose-expansion portion of the study also undergo tumor biopsies during screening and on study. Patients are followed for 30 days after removal from study treatment, and then followed every 12 months for 36 months or until death whichever comes first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage IV Breast Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (magrolimab, olaparib)
Arm Type
Experimental
Arm Description
Patients receive magrolimab IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of subsequent cycles. Patients also receive olaparib PO BID during each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and CT and/or MRI throughout the trial. Patients in the dose-expansion portion of the study also undergo tumor biopsies during screening and on study.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Other Intervention Name(s)
BIOPSY_TYPE, Bx
Intervention Description
Undergo biopsies
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo collection of blood samples
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
Intervention Type
Biological
Intervention Name(s)
Magrolimab
Other Intervention Name(s)
Hu5F9-G4, ONO-7913
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Olaparib
Other Intervention Name(s)
AZD 2281, AZD-2281, AZD2281, KU-0059436, Lynparza, Olanib, Olaparix, PARP Inhibitor AZD2281
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) of olaparib with magrolimab (Dose Escalation)
Description
The MTD is defined as the highest dose level with no more than 1/6 dose-limiting toxicities (DLT). DLT is defined as any grade >= 3 non-hematologic toxicity despite best supportive care or grade >= 4 hematologic toxicity per Common Terminology Criteria for Adverse Events version 5.0 attributed as possibly, probably, or definitely related to study drugs during the first cycle of therapy (28 days) lasting more than 7 days.
Time Frame
Up to 28 days after the beginning of the treatment cycle
Title
Tumor ribonucleic acid (RNA) sequencing of interferon- gamma (IFN-g) signature, TGF-beta signature, and STING pathway, as well as CD47 expression (Dose Expansion)
Description
Will be compared between tumor tissue using a non-parametric paired test, at a significance level (alpha) of 0.05. This will only be performed in the expansion cohorts.
Time Frame
Baseline and cycle 2 days 1-7
Title
Tumor macrophage infiltrate (Dose Expansion)
Description
Will be assessed using multiplex immune imaging and their phenotype (M1/M2 ratio) as well as STING pathway activation (TBK1, IRF3 and IFNB protein expression). Will be compared between tumor tissue using a non-parametric paired test, at a significance level (alpha) of 0.05. This will only be performed in the expansion cohorts.
Time Frame
Baseline and cycle 2 days 1-7
Title
Tumor infiltrating immune cells (Dose Expansion)
Description
Will be assessed using multiplex immune imaging. Will be compared between tumor tissue using a non-parametric paired test, at a significance level (alpha) of 0.05. This will only be performed in the expansion cohorts.
Time Frame
Baseline and cycle 2 days 1-7
Title
Recommended phase 2 dose (Dose Expansion)
Description
The RP2D determination will include both the DLT period for the MTD, as well as consideration of later cycle DLTs and the overall safety profile..
Time Frame
Up to 28 days after the beginning of the treatment cycle
Title
Incidence of adverse events (Dose Expansion)
Description
Adverse events will be scored by CTCAE v5.0 and tabulated.
Time Frame
Up to 30 days after the last administration
Secondary Outcome Measure Information:
Title
Tumor genomic markers
Description
Deoxyribonucleic acid (DNA) damage response (DDR) genes including BRCA 1, 2 and other genes such as RAD51C, RAD51D, and PALB, polymorphism status, mutational burden and microsatellite instability (MSI) status will be assessed in available pre-treatment tissue and correlated with immune response by whole exome sequencing.
Time Frame
Up to 36 months
Title
Olaparib and magrolimab trough and potentially area under the curve
Description
Descriptive data will be reported and compared with historical controls.
Time Frame
Magrolimab: Cycle 1, day 1 (C1D1): Pre-treatment (Pre); C1D8: Pre, after end of infusion, 1 hour after infusion; C1D15: Pre; Olaparib: C1D1, C1D8, C1D15: Pre
Other Pre-specified Outcome Measures:
Title
Objective response rate (ORR)
Description
Treatment response will be assessed for all patients based on Response Evaluation Criteria in Solid Tumors version 1.1: complete response (CR), partial response (PR), stable disease (SD), and progression of disease (PD). ORR is defined as the addition of CR and PR. The probability of ORR will be estimated with exact 95% binomial confidence intervals. Clinical benefit rate is defined as the addition of CR, PR and SD.
Time Frame
Up to 36 months
Title
Progression free survival (PFS)
Description
Will be assessed using the Kaplan-Meier method, along with 95% confidence regions.
Time Frame
Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 36 months
Title
Peripheral blood cytokines and immune cell populations
Description
Peripheral blood cytokines assessed by Luminex or MesoScale Discovery assays. Immune cell populations assessed by multicolor flow cytometry. Cytokine levels and immune cell population levels will be followed through treatment and may be compared with a non-parametric paired test, at a significance level (alpha) of 0.05.
Time Frame
Pre, C2D1, C3D1, C5D1, and at progression, assessed up to 36 months
Title
Circulating tumor (ct)DNA assessment of BRCA and other genes
Description
Will include genes such as RAD51C, RAD51D, and PALB2 over time. DDR gene expression will be followed through treatment and may be compared descriptively.
Time Frame
Baseline, C3D1, and at progression, assessed up to 36 months
Title
Drug exposure and response and/or toxicity
Description
Will correlate drug exposure with response and/or toxicity with pharmacodynamics (biological endpoints, toxicity and efficacy) and analyzed using nonparametric statistics.
Time Frame
Up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of metastatic and/or recurrent solid tumors (therapy naïve or those with prior therapy) with pathogenic BRCA 1/2 mutated cancers where olaparib is indicated as standard of care therapeutic option (not maintenance) as below: Metastatic breast cancer: Germline - Yes (Y); Somatic - No (N): Must have had prior chemotherapy (chemo) (adjuvant [adj], treatment); or if hormone receptor positive (HR+), must have had prior endocrine therapy or deemed inappropriate for endocrine treatment Metastatic castrate-resistant prostate cancer (CPRC) Germline - Y; Somatic - Y: Treatment after progressive disease on anti-androgens BRCA mutation status must be confirmed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory (lab) Patients >= 18 years of age. Because no dosing or adverse event data are currently available on the use of Hu5F9-G4 (magrolimab) in combination with olaparib in patients < 18 years of age, children are excluded from this study Patients may not have had prior PARP inhibitor in the metastatic setting when given for therapeutic purposes. Patients with breast cancer who received adjuvant PARP inhibitor (i) are eligible. Patients who had prior maintenance therapy are eligible. At least 4 weeks or 4 prior drug half-lives (whichever is shorter) must have elapsed since completion of the previous systemic therapy Expansion Cohort: Willingness and feasibility to undergo pre and post treatment biopsy Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Absolute neutrophil count >= 1,500/mcL Platelets >= 100,000/mcL Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN Glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2 Hemoglobin (Hgb) >= 9 g/dL Patients infected with human immunodeficiency virus (HIV) who are on effective anti-retroviral therapy with undetectable viral load within 6 months may be eligible for this trial For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients with prior brain metastasis that was treated with evidence of resolution or stable disease for 6 months are eligible. Patients are required to be stable and fully tapered off steroids for at least >= 1 month Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better Women of child-bearing potential, and men who are sexually active and their partner who may become pregnant, must use contraception during treatment and at least for 6 months (women) and 4 months (men) after the last dose of magrolimab and olaparib. Breastfeeding is not allowed during treatment and for one month after receiving the last dose of therapy Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Exclusion Criteria: Previous anti-CD47 therapy Concomitant use of strong CYP3A4 inhibitors/inducers can cause clinically significant drug-interactions; thus, study patients who require the use of these CYP enzymes continuously should be excluded. Study patients need to come off 3 eliminated half-lives of moderate CYP3A4 inhibitors and 5 eliminated half-lives of strong CYP3A4 inhibitors Patients who require immunosuppressive treatments for comorbidities are not eligible Gastrointestinal pathology or history that adversely impacts the ability to take or absorb oral medication Inability to comply with the protocol and/or not willing or who will not be available for follow-up assessments Patients who are receiving any other investigational agents History of allergic reactions attributed to compounds of similar chemical or biologic composition to magrolimab or other agents used in study Patients with uncontrolled intercurrent illness Pregnant women are excluded from this study because Hu5F9-G4 (magrolimab) is an anti-CD47 monoclonal antibody agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Hu5F9-G4 (magrolimab), breastfeeding should be discontinued if the mother is treated with Hu5F9-G4 (magrolimab). These potential risks may also apply to other agents used in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haider S Mahdi
Organizational Affiliation
University of Pittsburgh Cancer Institute LAO
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Cancer Institute (UPCI)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-647-8073
First Name & Middle Initial & Last Name & Degree
Haider S. Mahdi

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
IPD Sharing URL
https://grants.nih.gov/policy/sharing.htm

Learn more about this trial

Testing the Addition of Immunotherapy With Hu5F9-G4 (Magrolimab) to the Usual PARP Inhibitor, Olaparib for Treatment of Metastatic or Recurrent Breast or Castrate-Resistant Prostate Cancer With BRCA Mutations

We'll reach out to this number within 24 hrs