Metastatic Castration-Resistant Prostate Cancer
Conditions
Keywords
Metastatic Castration-Resistant Prostate Cancer, mCRPC, ABBV-969
Brief summary
Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy. ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 230 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Interventions
DRUGABBV-969
Intravenous (IV) Infusion
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. * Estimated life expectancy \> 6 months. * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Must have progressed on prior novel hormonal agents (NHAs) (e.g., abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or castration-resistant prostate cancer (CRPC). Determination of progression is done per local investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and/or Prostate Cancer Working Group 3 (PCWG3). * Serum testosterone levels \<= 50 ng/dL (\<= 1.73 nmol/L) within the screening period and prior to the first dose of the study drug. * Must have received at least one NHA (e.g., enzalutamide and/or abiraterone). Additionally, participants must have received at least one taxane for prostate cancer (or are intolerant to, or unable to get access to taxanes). * Must have \>= 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained \<= 28 days prior to beginning study therapy. * Serum prostate specific antigen (PSA) level \>= 1.0 ng/mL. * Availability of representative baseline tumor tissue (most recent archived tumor tissue after any novel hormonal agent (NHA) and/or any Prostate-Specific Membrane Antigen (PSMA) targeted therapy or fresh biopsy collected during screening if collecting a fresh biopsy at screening is deemed safe in the judgment of the investigator) suitable for immunohistochemistry (IHC) testing. * Laboratory values meeting the criteria laid out in the protocol. * QT interval corrected for heart rate (QTc) \<= 470 msec (using Fridericia's correction), no \>= Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.
Exclusion criteria
* Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia. * History of other active malignancy, as laid out in the protocol. * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis on screening chest CT scan. * History of or active idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. * History of or active clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Up to 3 Years | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. |
| Percentage of Participants Achieving Prostate Specific Antigen (PSA) response | Up to 3 Years | PSA response is defined as \>= 50% PSA decrease from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of ABBV-969 | Up to 3 Years | Cmax is defined as the maximum observed plasma/serum concentration of ABBV-969. |
| Time to Maximum Observed Concentration (Tmax) of ABBV-969 | Up to 3 Years | Tmax is defined as the time to maximum observed concentration of ABBV-969. |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-969 | Up to 3 Years | Terminal phase elimination half-life of ABBV-969. |
| Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969 | Up to 3 Years | Area under the plasma/serum concentration versus time curve (AUC) of ABBV-969. |
| Antidrug Antibody (ADA) | Up to 3 Years | Incidence and concentration of anti-drug antibodies. |
| Neutralizing Antibodies (nAbs) | Up to 3 Years | Incidence and concentration of neutralizing antibodies. |
| Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase) | Up to 2 Years | The RP2D of ABBV-969 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data. |
Countries
Australia, Canada, France, Israel, Japan, Spain, United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed