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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

NCT06318273 · AbbVie
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Official title
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer
About this study
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.
Eligibility criteria
Inclusion Criteria: * Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. * Estimated life expectancy \> 6 months. * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * 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 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 if collecting a fresh biopsy at screening is deemed safe in the judgment of the investigator) suitable for immunohistochemistry (IHC) testing. * 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. Exclusion 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.
Study design
Enrollment target: 230 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-03-08
Estimated completion: 2027-05
Last updated: 2026-04-08
Interventions
Drug: ABBV-969
Primary outcomes
  • Percentage of Participants With Adverse Events (AEs) (Up to 3 Years)
  • Percentage of Participants Achieving Prostate Specific Antigen (PSA) response (Up to 3 Years)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (26)
City of Hope /ID# 262059Recruiting
Duarte, California, United States
Univ California, San Francisco /ID# 261715Recruiting
San Francisco, California, United States
Yale University School of Medicine /ID# 262234Recruiting
New Haven, Connecticut, United States
AdventHealth Orlando /ID# 261686Recruiting
Orlando, Florida, United States
University of Chicago Medical Center /ID# 261605Recruiting
Chicago, Illinois, United States
START Midwest /ID# 264295Recruiting
Grand Rapids, Michigan, United States
Carolina BioOncology Institute /ID# 261602Recruiting
Huntersville, North Carolina, United States
Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687Recruiting
Providence, Rhode Island, United States
NEXT Oncology /ID# 261601Recruiting
San Antonio, Texas, United States
Chris O'Brien Lifehouse /ID# 261731Recruiting
Camperdown, New South Wales, Australia
Ballarat Base Hospital /ID# 264294Recruiting
Ballarat, Victoria, Australia
St Vincent's Hospital /ID# 264293Recruiting
Fitzroy, Victoria, Australia
Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 270890Recruiting
Montreal, Quebec, Canada
McGill University Health Centre - Glen Site. /ID# 271275Recruiting
Montreal, Quebec, Canada
Centre Oscar Lambret /ID# 270602Recruiting
Lille, Nord, France
Centre Leon Berard /ID# 270605Recruiting
Lyon, Rhone, France
Institut Gustave Roussy /ID# 270603Recruiting
Villejuif, Île-de-France Region, France
The Chaim Sheba Medical Center /ID# 261772Recruiting
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 261770Recruiting
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 261771Recruiting
Jerusalem, Israel
National Cancer Center Hospital East /ID# 261606Recruiting
Kashiwa-shi, Chiba, Japan
Kyoto University Hospital /ID# 261861Recruiting
Kyoto, Kyoto, Japan
National Cancer Center Hospital /ID# 261698Recruiting
Chuo-ku, Tokyo, Japan
Hospital Universitario Vall de Hebron /ID# 270889Recruiting
Barcelona, Spain
Hospital Universitario HM Sanchinarro /ID# 271345Recruiting
Madrid, Spain
Hospital Universitario Virgen del Rocio /ID# 270617Recruiting
Seville, Spain
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 · TrialPath