Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group comprises subjects who must have received at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). The second group comprises subjects who are cytotoxic chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223. Both groups of subjects must also have received and progressed on abiraterone acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study. Subjects will receive up to eight doses of PSMA ADC approximately once every three weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: PSMA ADC | Experimental | Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA ADC | Drug | PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Total Serum PSA Response | Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%. | 24 Weeks |
| CTC Response | Circulating tumor cells (CTC) response was examined at two levels: at least 30% decrease or at least 50% decrease in CTC levels. Response was defined as any decrease from baseline of at least 30% or 50%. | 24 Weeks |
| Overall Radiologic Response | Overall radiologic response was measured prior to the first dose of study drug, at predose of cycle 5, and at the end of study. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper & lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment depended on the achievement of both measurement and confirmation criteria. | 24 weeks |
Not provided
Not provided
Inclusion Criteria:
A diagnosis of metastatic castration-resistant prostate cancer.
a) Prior history of treatment with at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). If a subject has received more than two cytotoxic chemotherapy regimens, Sponsor approval is required for study participation.
OR
b) No prior history of treatment with a cytotoxic chemotherapy regimen.
Must have received and progressed on abiraterone acetate and/or enzalutamide. If subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Life expectancy ≥ six months.
Cytotoxic chemotherapy-naïve subjects ONLY must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223.
Exclusion Criteria:
Treatment within 30 days prior to first dose of study drug of the following:
Clinically significant cardiac disease or severe debilitating pulmonary disease
An acute infection requiring ongoing antibiotic therapy
Any prior treatment with PSMA ADC or other therapies targeting PSMA, or other antibody drug conjugate (ADC) products that contain monomethyl auristatin E (MMAE) (e.g., brentuximab vedotin, glembatumumab vedotin, ASG-5ME, RG7450) unless approved by Sponsor.
History of drug and/or alcohol abuse
History of pancreatitis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vivien Wong, PhD | Progenics Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35205 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: PSMA ADC | PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tucson |
| Arizona |
| 85724 |
| United States |
| Burbank | California | 91505 | United States |
| Encinitas | California | 92024 | United States |
| Los Angeles | California | 90024 | United States |
| San Diego | California | 92123 | United States |
| Denver | Colorado | 80218 | United States |
| New Haven | Connecticut | 06520 | United States |
| Norwalk | Connecticut | 06856 | United States |
| Port Saint Lucie | Florida | 34952 | United States |
| Honolulu | Hawaii | 96819 | United States |
| Fairway | Kansas | 66205 | United States |
| New Orleans | Louisiana | 70115 | United States |
| Baltimore | Maryland | 21201 | United States |
| Baltimore | Maryland | 21205 | United States |
| Rockville | Maryland | 20850 | United States |
| Boston | Massachusetts | 02111 | United States |
| Ann Arbor | Michigan | 28109 | United States |
| Rochester | Minnesota | 55905 | United States |
| Omaha | Nebraska | 68130 | United States |
| Las Vegas | Nevada | 89169 | United States |
| Lake Success | New York | 11042 | United States |
| New York | New York | 10065 | United States |
| Rochester | New York | 14642 | United States |
| Stony Brook | New York | 11794 | United States |
| Huntersville | North Carolina | 28078 | United States |
| Raleigh | North Carolina | 27607 | United States |
| Cleveland | Ohio | 44195 | United States |
| Pittsburgh | Pennsylvania | 15232 | United States |
| Providence | Rhode Island | 02906 | United States |
| Greenville | South Carolina | 29605 | United States |
| Myrtle Beach | South Carolina | 29572 | United States |
| Memphis | Tennessee | 38120 | United States |
| Dallas | Texas | 75390 | United States |
| Norfolk | Virginia | 23502 | United States |
| Seattle | Washington | 98101 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: PSMA ADC Chemotherapy-experienced | PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles. |
| BG001 | Arm 2: PSMA ADC Chemotherapy-naive | PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Prostate specific antigen (PSA) | Mean | Standard Deviation | ug/mL |
| |||||||||||||||
| PSA | Median | Full Range | ug/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Total Serum PSA Response | Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%. | Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a PSA baseline value and at least one post-baseline value. | Posted | Number | % of responders | 24 Weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | CTC Response | Circulating tumor cells (CTC) response was examined at two levels: at least 30% decrease or at least 50% decrease in CTC levels. Response was defined as any decrease from baseline of at least 30% or 50%. | Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a CTC baseline value and at least one post-baseline value. | Posted | Number | % of responders | 24 Weeks |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Overall Radiologic Response | Overall radiologic response was measured prior to the first dose of study drug, at predose of cycle 5, and at the end of study. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper & lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment depended on the achievement of both measurement and confirmation criteria. | Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The full modified Intention-to-Treat (mITT) population (n = 119) was examined. | Posted | Number | % of subjects | 24 weeks |
|
24 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PSMA ADC Chemotherapy-experienced | PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation). | 43 | 84 | 84 | 84 | ||
| EG001 | Chemotherapy-naive | PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it. | 18 | 35 | 35 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hemorrhagic anemia | Blood and lymphatic system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA®, Version 15 | Systematic Assessment |
| |
| ECG QT prolonged | Investigations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Decreased neutrophil count | Investigations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA®, Version 15 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Vertigo | Cardiac disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Peripheral edema | General disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Upper resiratory tract infection | Infections and infestations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA®, Version 15 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA®, Version 15 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA®, Version 15 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Decreased neutrophil count | Investigations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Decreased weight | Investigations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA®, Version 15 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA®, Version 15 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Peripheral neuropathy | Nervous system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA®, Version 15 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA®, Version 15 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vincent A. DiPippo | Progenics Pharmaceuticals, Inc. | (646) 975-2502 | vdipippo@progenics.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C569421 | PSMA ADC |
Not provided
Not provided
Not provided
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | Chemotherapy-naive | PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it. |
|
|