[M24-742]First-in-Human Study of ABBV-969 in Metastatic Castration-Resistant Prostate Cancer

JRCT ID: jRCT2051240092

Registered date:17/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Metastatic Castration-Resistant Prostate Cancer
• Date of first enrollment: 01/08/2024
• Target sample size: 12
• Countries of recruitment: United States of America,Japan,Israel,Japan,Australia,Japan
• Study type: Interventional

Intervention(s)

Part 1:ABBV-969 Dose Escalation:Participants will receive escalating doses of ABBV-969(Intravenous (IV) Infusion)
Part 2A:ABBV-969 Dose Expansion:Participants will receive dose A of ABBV-969 from part 1(Intravenous (IV) Infusion)
Part 2B:ABBV-969 Dose Expansion:Participants will receive dose B of ABBV-969 from part 1(Intravenous (IV) Infusion)

Outcome(s)

Primary Outcome

-Percentage of Participants With Adverse Events (AEs) [Time Frame: 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 [Time Frame: Up to 3 Years]
-PSA response is defined as >= 50% PSA decrease from baseline.

Secondary Outcome

-Maximum Observed Plasma Concentration (Cmax) of ABBV-969 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: Up to 3 Years]
-Area under the plasma/serum concentration versus time curve (AUC) of ABBV-969.
-Antidrug Antibody (ADA) [Time Frame: Up to 3 Years]
-Incidence and concentration of anti-drug antibodies.
-Neutralizing Antibodies (nAbs) [Time Frame: Up to 3 Years]
-Incidence and concentration of neutralizing antibodies.
-Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase) [Time Frame: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

-Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
-Estimated life expectancy > 6 months.
-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 have refused, 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 phase) suitable for immunohistochemistry (IHC) testing. This requirement may be waived at the discretion of the AbbVie Medical Monitor if collecting a biopsy at screening would place the subject at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator.
-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.

Exclude 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.

Related Information

• Primary Sponsor: Tsutsui Atsuko
• Secondary ID(s): NCT06318273