A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer
- Conditions
- Metastatic Castration-Resistant Prostate Cancer
- Registration Number
- NCT06318273
- Lead Sponsor
- AbbVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Histological, pathological, and/or cytological confirmation of adenocarcinoma of the<br> prostate.<br><br> - Estimated life expectancy > 6 months.<br><br> - Must have progressed on prior novel hormonal agents (NHAs) (e.g., abiraterone<br> acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or<br> castration-resistant prostate cancer (CRPC). Determination of progression is done<br> per local investigator according to Response Evaluation Criteria in Solid Tumors<br> (RECIST), version 1.1 and/or Prostate Cancer Working Group 3 (PCWG3).<br><br> - Serum testosterone levels <= 50 ng/dL (<= 1.73 nmol/L) within the screening period<br> and prior to the first dose of the study drug.<br><br> - Must have received at least one NHA (e.g., enzalutamide and/or abiraterone).<br> Additionally, participants must have received at least one taxane for prostate<br> cancer (or have refused, or are intolerant to, or unable to get access to taxanes).<br><br> - Must have >= 1 metastatic lesion that is present on baseline computed tomography<br> (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained <= 28 days<br> prior to beginning study therapy.<br><br> - Serum prostate specific antigen (PSA) level >= 1.0 ng/mL.<br><br> - Availability of representative baseline tumor tissue (most recent archived tumor<br> tissue after any novel hormonal agent (NHA) and/or any Prostate-Specific Membrane<br> Antigen (PSMA) targeted therapy or fresh biopsy collected during screening phase)<br> suitable for immunohistochemistry (IHC) testing. This requirement may be waived at<br> the discretion of the AbbVie Medical Monitor if collecting a biopsy at screening<br> would place the subject at risk of harm or would require a technically complicated<br> procedure based on tumor location as assessed by the investigator.<br><br> - Laboratory values meeting the criteria laid out in the protocol.<br><br> - QT interval corrected for heart rate (QTc) < 470 msec (using Fridericia's<br> correction), no >= Grade 3 arrythmia, and no other clinically significant cardiac<br> abnormalities.<br><br>Exclusion Criteria:<br><br> - Unresolved Grade 2 or higher toxicities related to previous anticancer therapy<br> except alopecia.<br><br> - History of other active malignancy, as laid out in the protocol.<br><br> - History of interstitial lung disease (ILD) or pneumonitis that required treatment<br> with systemic steroids, nor any evidence of active ILD or pneumonitis on screening<br> chest CT scan.<br><br> - History of or active idiopathic pulmonary fibrosis, organizing pneumonia (e.g.,<br> bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.<br><br> - History of or active clinically significant, intercurrent lung-specific illnesses<br> including, but not limited to those listed in the protocol.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs);Percentage of Participants Achieving Prostate Specific Antigen (PSA) response
- Secondary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of ABBV-969;Time to Maximum Observed Concentration (Tmax) of ABBV-969;Terminal Phase Elimination Half-Life (t1/2) of ABBV-969;Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969;Antidrug Antibody (ADA);Neutralizing Antibodies (nAbs);Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase)