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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
Intravenous (IV) Infusion
City of Hope /ID# 262059
Duarte, California, United States
RECRUITINGUniv California, San Francisco /ID# 261715
San Francisco, California, United States
RECRUITINGYale University School of Medicine /ID# 262234
New Haven, Connecticut, United States
RECRUITINGAdventHealth Orlando /ID# 261686
Orlando, Florida, United States
Percentage of Participants With Adverse Events (AEs)
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.
Time frame: Up to 3 Years
Percentage of Participants Achieving Prostate Specific Antigen (PSA) response
PSA response is defined as \>= 50% PSA decrease from baseline.
Time frame: Up to 3 Years
Maximum Observed Plasma Concentration (Cmax) of ABBV-969
Cmax is defined as the maximum observed plasma/serum concentration of ABBV-969.
Time frame: Up to 3 Years
Time to Maximum Observed Concentration (Tmax) of ABBV-969
Tmax is defined as the time to maximum observed concentration of ABBV-969.
Time frame: Up to 3 Years
Terminal Phase Elimination Half-Life (t1/2) of ABBV-969
Terminal phase elimination half-life of ABBV-969.
Time frame: Up to 3 Years
Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969
Area under the plasma/serum concentration versus time curve (AUC) of ABBV-969.
Time frame: Up to 3 Years
Antidrug Antibody (ADA)
Incidence and concentration of anti-drug antibodies.
Time frame: Up to 3 Years
Neutralizing Antibodies (nAbs)
Incidence and concentration of neutralizing antibodies.
Time frame: Up to 3 Years
Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase)
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.
Time frame: Up to 2 Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Chicago Medical Center /ID# 261605
Chicago, Illinois, United States
RECRUITINGSTART Midwest /ID# 264295
Grand Rapids, Michigan, United States
RECRUITINGCarolina BioOncology Institute /ID# 261602
Huntersville, North Carolina, United States
RECRUITINGLifespan Cancer Institute at Rhode Island Hospital /ID# 261687
Providence, Rhode Island, United States
RECRUITINGNEXT Oncology /ID# 261601
San Antonio, Texas, United States
RECRUITINGChris O'Brien Lifehouse /ID# 261731
Camperdown, New South Wales, Australia
RECRUITING...and 16 more locations