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A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Men With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)

Primary Purpose

Metastatic Castration-resistant Prostate Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BAY3546828
BAY2616505
BAY2315493
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria: mCRPC with pathological confirmation of adenocarcinoma without small-cell or neuroendocrine features. Previous treatment with at least 1 Novel androgen axis drug (NAAD) (e.g., enzalutamide, apalutamide, darolutamide and/or abiraterone). Prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L). Prior taxane treatment: Dose Escalation: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for or refused taxane therapy on consultation with their physician Dose Expansion Group A: Participants must have had prior treatment with at least 1 but no more than 2 taxane regimens, in the castration-resistant setting Dose Expansion Group B: Participants must not have received taxane therapy since becoming castration-resistant Dose Expansion Group C: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for or refused taxane therapy on consultation with their physician Prior treatment with 177Lu-PSMA is required for participants in Dose Expansion Group C only. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements within 28 days before start of study treatment: Hemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) ≥1500/mm^3 Platelet count ≥100,000/mm^3 Total bilirubin ≤1.5 x the Upper limit of normal (ULN), except if confirmed history of Gilbert's disease Alanine transaminase (ALT) and Aspartate transaminase (AST) ˂2.5 x ULN (≤5 x ULN for participants with liver involvement) Participants on a stable dose of anticoagulation therapy are allowed to participate if they have no sign of bleeding or clotting, and Prothrombin time international normalized ratio (PT/INR) and activated partial thromboplastin time (aPTT) test results are acceptable at the Investigator's discretion Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m^2, according to the Modified Diet in Renal Disease (MDRD) abbreviated formula and creatinine clearance (CrCl) >60 mL/min based on Cockcroft-Gault formula Participants must have at least one Prostate-specific membrane antigen (PSMA)-positive distant metastatic lesion on the screening PSMA PET/CT scan using the study-designated PSMA PET tracers, as determined by the site Investigator. For eligibility purposes, a PSMA-positive lesion must have activity greater than the liver by visual assessment of the screening PSMA PET/CT. A PSMA-positive metastatic lesion should not correspond to a normal tissue structure or benign lesion. Exclusion Criteria: Participants who have any of the following tumor lesions which are PSMA negative AND meet the size criteria below are excluded as determined by the site investigator. A PSMA-negative lesion for eligibility purposes must have activity equal to or less than the liver by visual assessment of the screening PSMA PET/CT scan using the study-designated PSMA PET/CT tracers. A PSMA-negative metastatic lesion should not correspond to a normal tissue structure or benign lesion. a. Any single or multiple lymph node(s) ≥2.5cm in the short axis. b. Any solid organ metastasis (e.g., lung, liver, adrenal glands, etc.) that is ≥1 cm in the short axis. c. Any bone metastasis with a soft tissue component ≥ 1cm in short axis with the soft tissue component being PSMA-negative. PSMA-negative osseous metastases without a soft tissue component do not exclude a participant. d. Predominantly necrotic lesions with greater than 1cm of enhancing tissue on contrast-enhanced Computer tomography / magnetic resonance imaging (CT/MRI). Prior systemic anticancer therapy including chemotherapy, NAAD, biologic therapy, immunotherapy, or investigational therapies within 4 weeks of the start of study treatment, except luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH). Start of study treatment is allowed in shorter timeframes if 5 half-lives of the prior drug(s) have elapsed. Prior radiopharmaceutical treatment using 225Ac. Other prior radiopharmaceutical treatments: Dose escalation and Dose expansion Groups A and B: Prior treatment with a radiopharmaceutical is prohibited. Dose expansion Group C: Prior treatment with a radiopharmaceutical is prohibited with the following exceptions: Prior treatment with radium-223 dichloride more than 3 months before the start of study treatment is permitted; and prior treatment with 177Lu PSMA more than 6 weeks before the start of study treatment is required. Prior definitive therapy (radiotherapy or surgery) completed less than 6 weeks before the start of study treatment. Note that palliative radiotherapy completed less than 6 weeks before the start of study treatment will be allowed if: (i) no more than 10% of the participants' bone marrow is irradiated, (ii) it does not encompass all potential target/measurable lesions for participants in dose expansion. Toxic effects of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from prior anticancer therapy not yet stabilized or where significant post-treatment toxicities have been observed. Chronic toxic effects of CTCAE Grade ≤2 from prior anticancer therapy where no further resolution is expected do not require exclusion with agreement between the Investigator and Sponsor (e.g., chemotherapy-induced neuropathy, fatigue, alopecia, anorexia, etc.).

Sites / Locations

  • HUS, Meilahden sairaalaRecruiting
  • CRST Clinical Research Services Turku
  • Universitair Medisch Centrum Groningen
  • Addenbrookes Hospital
  • Royal Marsden NHS Trust (Surrey)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose escalation of BAY3546828

Dose expansion group A of BAY3546828

Dose expansion group B of BAY3546828

Dose expansion group C of BAY3546828

89Zr-pelgi PET/CT

Arm Description

Participants with advanced metastatic castration-resistant prostate cancer (mCRPC) will receive 225Ac-pelgi dose in a stepwise fashion, according to a predefined dose escalation scheme.

Participants with advanced mCRPC with at least 1 but no more than 2 prior taxane regimens. No prior radionuclide therapy

Participants with advanced mCRPC who have not received taxane chemotherapy since becoming castration-resistant. No prior radionuclide therapy.

Participants with advanced mCRPC after prior Lutetium-177 labeled PSMA ligand (177Lu-PSMA) treatment.

A substudy utilizing the BAY2616505, referred to hereafter as 89Zr-pelgi imaging agent and Hybrid positron emission tomography and computed tomography scan (PET/CT) imaging will be performed during the dose escalation part of the study at selected sites.

Outcomes

Primary Outcome Measures

Dose escalation & Dose expansion: The Incidence of treatment-emergent adverse events (TEAEs) including treatment-emergent serious adverse events (TESAEs)
Dose escalation & Dose expansion: The Severity of TEAEs including TESAEs
Dose escalation: Incidence of dose limiting toxicities (DLTs) at each 225Ac dose level during the DLT observation period
DLTs will be summarized by MedDRA system organ class, preferred term and worst CTCAE grade.
Dose escalation: Objective response rate (ORR) at each 225Ac dose level during the DLT observation period
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per PCWG3 guidelines, as assessed by the Investigator.
Dose escalation: ≥50% decline in Prostate-specific antigen value from baseline (Cycle 1, Day 1) (PSA50) response at each 225Ac dose level during the DLT observation period
PSA partial response is defined as a ≥50% decline in PSA value from Cycle 1 Day 1 (baseline). This PSA decline must be confirmed to be sustained by a second PSA value obtained 3 to 4 or more weeks later.
Dose expansion: Objective response rate (ORR) by Prostate Cancer Working Group 3 (PCWG3) guidelines based on investigator review
Dose expansion: ≥50% decline in Prostate-specific antigen value from baseline (Cycle 1, Day 1) (PSA50) response at 12 weeks or later
Dose expansion: Best overall Prostate-specific antigen (PSA) response

Secondary Outcome Measures

Dose escalation & Dose expansion: Radiologic progression-free survival (rPFS ) by PCWG3 based on investigator review
rPFS is defined as the time from the start of study treatment to the date of first observed disease progression (Investigator's radiological assessment by PCWG3) or death due to any cause, if death occurs before progression is documented.
Dose escalation & Dose expansion: Duration of PSA50 response
Duration of PSA50 response by PCWG3 is defined as the time from the first documented PSA partial response as defined above to PSA progression by PCWG3 or death (if death occurs before progression is documented).
Dose escalation & Dose expansion: Duration of response (DOR) by PCWG3 based on investigator review
DOR is defined as the time from the first documented objective response of PR or CR by PCWG3, whichever occurs earlier, to disease progression or death (if death occurs before progression is documented).
Dose escalation: Recommended dose level(s) of 225Ac-pelgi for dose expansion
Dose escalation: Recommended dose schedule of 225Ac-pelgi for dose expansion
Dose expansion: Recommended dose of 225Ac-pelgi for further clinical development
Dose expansion: Recommended dose schedule of 225Ac-pelgi for further clinical development
Dose escalation & Dose expansion: Maximum observed concentration (Cmax) of 225Ac
Dose escalation & Dose expansion: Maximum observed concentration (Cmax) of total antibody
Dose escalation & Dose expansion: Area under the curve (AUC) of 225Ac
Dose escalation & Dose expansion: Area under the curve (AUC) of total antibody

Full Information

First Posted
September 7, 2023
Last Updated
October 7, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT06052306
Brief Title
A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Men With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)
Official Title
A Phase 1 Open-label, First-in-human, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Actinium-225-macropa-pelgifatamab (BAY 3546828) in Participants With Advanced Metastatic Castration Resistant Prostate Cancer (mCRPC)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
June 8, 2027 (Anticipated)
Study Completion Date
June 16, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Researchers are looking for a better way to treat people who have advanced metastatic castration-resistant prostate cancer (mCRPC). In men with metastatic castration-resistant prostate cancer (mCRPC), the cancer of the prostate has spread to other parts of the body (metastatic) and does not respond to the lowering of testosterone levels in the body (castration resistant). The cancer is 'advanced' and is unlikely to be cured or controlled with currently available treatments. Despite new treatment options for men with prostate cancer in recent years, the cancer often returns and worsens. The study treatment actinium-225-macropa-pelgifatamab (also called 225Ac-pelgi or BAY3546828) is a new type of treatment under development for men with mCRPC who have already received available treatments or have few treatment options available. It works by binding to a protein on the surface of the cancer cells called prostate specific membrane antigen (PSMA). As it gives off a type of radioactivity that travels a very short distance, it kills the nearby (cancer) cells that express PSMA. The main purpose of this first-in-human study in men with mCRPC is to learn: How safe different doses of 225Ac-pelgi are. To what degree medical problems caused by 225Ac-pelgi can be tolerated by the participants? Which dose of 225Ac-pelgi is optimal for treatment (safe and working well)? How good is 225Ac-pelgi's anticancer activity? To answer this, the researchers will look at: The number and severity of medical problems that the participants have after treatment with 225Ac-pelgi (per dose level). The ratio of medical problems and anticancer activity per dose. Anticancer activity of the optimal 225Ac-pelgi dose as proportion of participants who have at least halved prostate-specific antigen (PSA) levels after 12 weeks of treatment or later and/or shrunken or no longer detectable tumors. The lowest PSA level reached after treatment start. Doctors keep track of all medical problems (also called adverse events) that participants have during the study, even if they do not think that they might be related to the study treatment. Anticancer activity is measured using cancer imaging techniques and change in blood level of a protein called PSA. PSA is made by normal and by cancerous cells in the body. The PSA level is taken as a marker for prostate cancer development and is usually elevated in men with mCRPC. In addition, researchers want to find out how 225Ac-pelgi moves into, through and out of the body. The study will have two parts. The first part, called dose escalation, is done to find the most appropriate dose and schedule that can be given in the second part of the study. For this, each participant will receive one of the predefined increasing doses of 225Ac-pelgi as an infusion into the vein. All participants in part 2, called dose expansion, will receive the most appropriate dose and schedule identified from the first part of the study. More than one dose level or schedule from part 1 may be tested. Both the participants and the study team know what treatment the participants will take. Participants in this study will take the study treatment 225Ac-pelgi once in a period of 6 weeks called a cycle. Each participant will have 4 of these treatment cycles, if the participant benefits from the treatment. Each participant will be in the study for up to nearly six years, including a first test (screening) phase of a maximum of 28 days, up to 12 months of treatment depending on the participant's benefit, and a follow-up phase of 60 months after the end of treatment. The following visits to the study site are planned: 2 during the screening phase, 8 in the first treatment cycle, 7 in subsequent cycles, and a visit 6 to 12 weeks after the last dose. In the following 12 months, visits are planned every 6 weeks and during the next 48 months phone calls or clinic visits are planned approximately every 12 weeks. In addition, a sub study during the dose escalation part will gather information on the distribution of the study treatment in the body, the proportion that binds to the cancer cells, and the resulting radiation at the tumor site. During the study, the study team will: Do physical examinations Check vital signs such as blood pressure, heart rate, and body temperature Take blood, and urine samples Examine heart health using echocardiogram and electrocardiogram (ECG) Take tumor samples Track 225Ac-pelgi in the body using gamma imaging (only selected sites) Check the tumor status using PET (positron emission tomography), CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scan Ask questions about the impact of the disease on the participants' wellbeing and activities of daily life (Eastern Cooperative Oncology Group Performance status (ECOG PS)).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-resistant Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose escalation of BAY3546828
Arm Type
Experimental
Arm Description
Participants with advanced metastatic castration-resistant prostate cancer (mCRPC) will receive 225Ac-pelgi dose in a stepwise fashion, according to a predefined dose escalation scheme.
Arm Title
Dose expansion group A of BAY3546828
Arm Type
Experimental
Arm Description
Participants with advanced mCRPC with at least 1 but no more than 2 prior taxane regimens. No prior radionuclide therapy
Arm Title
Dose expansion group B of BAY3546828
Arm Type
Experimental
Arm Description
Participants with advanced mCRPC who have not received taxane chemotherapy since becoming castration-resistant. No prior radionuclide therapy.
Arm Title
Dose expansion group C of BAY3546828
Arm Type
Experimental
Arm Description
Participants with advanced mCRPC after prior Lutetium-177 labeled PSMA ligand (177Lu-PSMA) treatment.
Arm Title
89Zr-pelgi PET/CT
Arm Type
Experimental
Arm Description
A substudy utilizing the BAY2616505, referred to hereafter as 89Zr-pelgi imaging agent and Hybrid positron emission tomography and computed tomography scan (PET/CT) imaging will be performed during the dose escalation part of the study at selected sites.
Intervention Type
Drug
Intervention Name(s)
BAY3546828
Intervention Description
Intravenous (IV) infusion on Day 1 of each cycle.
Intervention Type
Drug
Intervention Name(s)
BAY2616505
Intervention Description
Each participant in the substudy will receive the BAY2616505 administered at baseline (Day 1) by intravenous (i.v.), after completion of the screening period and before the first dose of BAY3546828 in Cycle 1.
Intervention Type
Drug
Intervention Name(s)
BAY2315493
Intervention Description
If the planned dose of total antibody is more than 1 mg, BAY2315493 will be administered by intravenous (i.v.), starting one hour prior to the i.v. injection of BAY2616505.
Primary Outcome Measure Information:
Title
Dose escalation & Dose expansion: The Incidence of treatment-emergent adverse events (TEAEs) including treatment-emergent serious adverse events (TESAEs)
Time Frame
After first administration of study treatment up to 42 days after the last dose of study treatment
Title
Dose escalation & Dose expansion: The Severity of TEAEs including TESAEs
Time Frame
After first administration of study treatment up to 42 days after the last dose of study treatment
Title
Dose escalation: Incidence of dose limiting toxicities (DLTs) at each 225Ac dose level during the DLT observation period
Description
DLTs will be summarized by MedDRA system organ class, preferred term and worst CTCAE grade.
Time Frame
Up to Cycle 3 (each cycle is 42 days)
Title
Dose escalation: Objective response rate (ORR) at each 225Ac dose level during the DLT observation period
Description
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per PCWG3 guidelines, as assessed by the Investigator.
Time Frame
Up to Cycle 3 (each cycle is 42 days)
Title
Dose escalation: ≥50% decline in Prostate-specific antigen value from baseline (Cycle 1, Day 1) (PSA50) response at each 225Ac dose level during the DLT observation period
Description
PSA partial response is defined as a ≥50% decline in PSA value from Cycle 1 Day 1 (baseline). This PSA decline must be confirmed to be sustained by a second PSA value obtained 3 to 4 or more weeks later.
Time Frame
Up to Cycle 3 (each cycle is 42 days)
Title
Dose expansion: Objective response rate (ORR) by Prostate Cancer Working Group 3 (PCWG3) guidelines based on investigator review
Time Frame
Up to 12 months after End of treatment
Title
Dose expansion: ≥50% decline in Prostate-specific antigen value from baseline (Cycle 1, Day 1) (PSA50) response at 12 weeks or later
Time Frame
At 12 weeks or later (up to 12 months after End of treatment)
Title
Dose expansion: Best overall Prostate-specific antigen (PSA) response
Time Frame
Up to 12 months after End of treatment
Secondary Outcome Measure Information:
Title
Dose escalation & Dose expansion: Radiologic progression-free survival (rPFS ) by PCWG3 based on investigator review
Description
rPFS is defined as the time from the start of study treatment to the date of first observed disease progression (Investigator's radiological assessment by PCWG3) or death due to any cause, if death occurs before progression is documented.
Time Frame
Up to 12 months after end of treatment
Title
Dose escalation & Dose expansion: Duration of PSA50 response
Description
Duration of PSA50 response by PCWG3 is defined as the time from the first documented PSA partial response as defined above to PSA progression by PCWG3 or death (if death occurs before progression is documented).
Time Frame
Up to 12 months after end of treatment
Title
Dose escalation & Dose expansion: Duration of response (DOR) by PCWG3 based on investigator review
Description
DOR is defined as the time from the first documented objective response of PR or CR by PCWG3, whichever occurs earlier, to disease progression or death (if death occurs before progression is documented).
Time Frame
Up to 12 months after end of treatment
Title
Dose escalation: Recommended dose level(s) of 225Ac-pelgi for dose expansion
Time Frame
Up to 4 cycles (each cycle is 42 days)
Title
Dose escalation: Recommended dose schedule of 225Ac-pelgi for dose expansion
Time Frame
Up to 4 cycles (each cycle is 42 days)
Title
Dose expansion: Recommended dose of 225Ac-pelgi for further clinical development
Time Frame
Up to 4 cycles (each cycle is 42 days)
Title
Dose expansion: Recommended dose schedule of 225Ac-pelgi for further clinical development
Time Frame
Up to 4 cycles (each cycle is 42 days)
Title
Dose escalation & Dose expansion: Maximum observed concentration (Cmax) of 225Ac
Time Frame
Cycle 1, cycle 2 (From Pre-dose up to Day 36 post-dose for each cycle)
Title
Dose escalation & Dose expansion: Maximum observed concentration (Cmax) of total antibody
Time Frame
Cycle 1, cycle 2 (From Pre-dose up to Day 36 post-dose for each cycle)
Title
Dose escalation & Dose expansion: Area under the curve (AUC) of 225Ac
Time Frame
Cycle 1, cycle 2 (From Pre-dose up to Day 36 post-dose for each cycle)
Title
Dose escalation & Dose expansion: Area under the curve (AUC) of total antibody
Time Frame
Cycle 1, cycle 2 (From Pre-dose up to Day 36 post-dose for each cycle)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mCRPC with pathological confirmation of adenocarcinoma without small-cell or neuroendocrine features. Previous treatment with at least 1 Novel androgen axis drug (NAAD) (e.g., enzalutamide, apalutamide, darolutamide and/or abiraterone). Prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L). Prior taxane treatment: Dose Escalation: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for or refused taxane therapy on consultation with their physician Dose Expansion Group A: Participants must have had prior treatment with at least 1 but no more than 2 taxane regimens, in the castration-resistant setting Dose Expansion Group B: Participants must not have received taxane therapy since becoming castration-resistant Dose Expansion Group C: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for or refused taxane therapy on consultation with their physician Prior treatment with 177Lu-PSMA is required for participants in Dose Expansion Group C only. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements within 28 days before start of study treatment: Hemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) ≥1500/mm^3 Platelet count ≥100,000/mm^3 Total bilirubin ≤1.5 x the Upper limit of normal (ULN), except if confirmed history of Gilbert's disease Alanine transaminase (ALT) and Aspartate transaminase (AST) ˂2.5 x ULN (≤5 x ULN for participants with liver involvement) Participants on a stable dose of anticoagulation therapy are allowed to participate if they have no sign of bleeding or clotting, and Prothrombin time international normalized ratio (PT/INR) and activated partial thromboplastin time (aPTT) test results are acceptable at the Investigator's discretion Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m^2, according to the Modified Diet in Renal Disease (MDRD) abbreviated formula and creatinine clearance (CrCl) >60 mL/min based on Cockcroft-Gault formula Participants must have at least one Prostate-specific membrane antigen (PSMA)-positive distant metastatic lesion on the screening PSMA PET/CT scan using the study-designated PSMA PET tracers, as determined by the site Investigator. For eligibility purposes, a PSMA-positive lesion must have activity greater than the liver by visual assessment of the screening PSMA PET/CT. A PSMA-positive metastatic lesion should not correspond to a normal tissue structure or benign lesion. Exclusion Criteria: Participants who have any of the following tumor lesions which are PSMA negative AND meet the size criteria below are excluded as determined by the site investigator. A PSMA-negative lesion for eligibility purposes must have activity equal to or less than the liver by visual assessment of the screening PSMA PET/CT scan using the study-designated PSMA PET/CT tracers. A PSMA-negative metastatic lesion should not correspond to a normal tissue structure or benign lesion. a. Any single or multiple lymph node(s) ≥2.5cm in the short axis. b. Any solid organ metastasis (e.g., lung, liver, adrenal glands, etc.) that is ≥1 cm in the short axis. c. Any bone metastasis with a soft tissue component ≥ 1cm in short axis with the soft tissue component being PSMA-negative. PSMA-negative osseous metastases without a soft tissue component do not exclude a participant. d. Predominantly necrotic lesions with greater than 1cm of enhancing tissue on contrast-enhanced Computer tomography / magnetic resonance imaging (CT/MRI). Prior systemic anticancer therapy including chemotherapy, NAAD, biologic therapy, immunotherapy, or investigational therapies within 4 weeks of the start of study treatment, except luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH). Start of study treatment is allowed in shorter timeframes if 5 half-lives of the prior drug(s) have elapsed. Prior radiopharmaceutical treatment using 225Ac. Other prior radiopharmaceutical treatments: Dose escalation and Dose expansion Groups A and B: Prior treatment with a radiopharmaceutical is prohibited. Dose expansion Group C: Prior treatment with a radiopharmaceutical is prohibited with the following exceptions: Prior treatment with radium-223 dichloride more than 3 months before the start of study treatment is permitted; and prior treatment with 177Lu PSMA more than 6 weeks before the start of study treatment is required. Prior definitive therapy (radiotherapy or surgery) completed less than 6 weeks before the start of study treatment. Note that palliative radiotherapy completed less than 6 weeks before the start of study treatment will be allowed if: (i) no more than 10% of the participants' bone marrow is irradiated, (ii) it does not encompass all potential target/measurable lesions for participants in dose expansion. Toxic effects of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from prior anticancer therapy not yet stabilized or where significant post-treatment toxicities have been observed. Chronic toxic effects of CTCAE Grade ≤2 from prior anticancer therapy where no further resolution is expected do not require exclusion with agreement between the Investigator and Sponsor (e.g., chemotherapy-induced neuropathy, fatigue, alopecia, anorexia, etc.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bayer Clinical Trials Contact
Phone
(+)1-888-84 22937
Email
clinical-trials-contact@bayer.com
Facility Information:
Facility Name
HUS, Meilahden sairaala
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Recruiting
Facility Name
CRST Clinical Research Services Turku
City
Turku
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Addenbrookes Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Royal Marsden NHS Trust (Surrey)
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Learn more about this trial

A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Men With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)

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