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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.
PSA response is defined as >= 50% PSA decrease from baseline.
Cmax is defined as the maximum observed plasma/serum concentration of ABBV-969.
Tmax is defined as the time to maximum observed concentration of ABBV-969.
Terminal phase elimination half-life of ABBV-969.
Area under the plasma/serum concentration versus time curve (AUC) of ABBV-969.
Incidence and concentration of anti-drug antibodies.
Incidence and concentration of neutralizing antibodies.
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.
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