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
- Interventions
- Registration Number
- NCT06318273
- Lead Sponsor
- AbbVie
- 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 140 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: ABBV-969 Dose Escalation ABBV-969 Participants will receive escalating doses of ABBV-969. Part 2 A: ABBV-969 Dose Expansion ABBV-969 Participants will receive dose A of ABBV-969 from part 1. Part 2 B: ABBV-969 Dose Expansion ABBV-969 Participants will receive dose B of ABBV-969 from part 1.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Prostate Specific Antigen (PSA) response Up to 3 Years PSA response is defined as \>= 50% PSA decrease from baseline.
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.
- Secondary Outcome Measures
Name Time Method Terminal Phase Elimination Half-Life (t1/2) of ABBV-969 Up to 3 Years Terminal phase elimination half-life of ABBV-969.
Antidrug Antibody (ADA) Up to 3 Years Incidence and concentration of anti-drug antibodies.
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.
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.
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.
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.
Trial Locations
- Locations (18)
City of Hope /ID# 262059
🇺🇸Duarte, California, United States
Univ California, San Francisco /ID# 261715
🇺🇸San Francisco, California, United States
Yale University School of Medicine /ID# 262234
🇺🇸New Haven, Connecticut, United States
AdventHealth Orlando /ID# 261686
🇺🇸Orlando, Florida, United States
University of Chicago Medical Center /ID# 261605
🇺🇸Chicago, Illinois, United States
START Midwest /ID# 264295
🇺🇸Grand Rapids, Michigan, United States
Carolina BioOncology Institute /ID# 261602
🇺🇸Huntersville, North Carolina, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687
🇺🇸Providence, Rhode Island, United States
NEXT Oncology /ID# 261601
🇺🇸San Antonio, Texas, United States
Chris O'Brien Lifehouse /ID# 261731
🇦🇺Camperdown, New South Wales, Australia
Ballarat Base Hospital /ID# 264294
🇦🇺Ballarat, Victoria, Australia
St Vincent's Hospital /ID# 264293
🇦🇺Fitzroy, Victoria, Australia
Rambam Health Care Campus /ID# 261770
🇮🇱Haifa, H_efa, Israel
The Chaim Sheba Medical Center /ID# 261772
🇮🇱Ramat Gan, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 261771
🇮🇱Jerusalem, Israel
National Cancer Center Hospital East /ID# 261606
🇯🇵Kashiwa-shi, Chiba, Japan
Kyoto University Hospital /ID# 261861
🇯🇵Kyoto-shi, Kyoto, Japan
National Cancer Center Hospital /ID# 261698
🇯🇵Chuo-ku, Tokyo, Japan