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

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT06318273
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABBV-969 — DRUG
    Intravenous (IV) Infusion

Study Details

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.

Key Dates

Start date
Mar 8, 2024
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
230 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: ABBV-969 Monotherapy Dose Escalation
    Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive ABBV-969 monotherapy once every 21 days
  • Experimental: Part 2 A: Monotherapy Dose Expansion/Dose Optimization
    Participants with mCRPC will receive dose A of ABBV-969 (dose levels determined in Part 1) for dose optimization.
  • Experimental: Part 2 B: Monotherapy Dose Expansion/Dose Optimization
    Participants with mCRPC will receive Dose B of ABBV-969 (dose levels determined in Part 1) for dose optimization.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to 3 Years ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
City of Hope /ID# 262059DuarteCalifornia91010-
Univ California, San Francisco /ID# 261715San FranciscoCalifornia94143-2204-
Yale University School of Medicine /ID# 262234New HavenConnecticut06510-
AdventHealth Orlando /ID# 261686OrlandoFlorida32803-
University of Chicago Medical Center /ID# 261605ChicagoIllinois60637-
START Midwest /ID# 264295Grand RapidsMichigan49546-
Carolina BioOncology Institute /ID# 261602HuntersvilleNorth Carolina28078-
Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687ProvidenceRhode Island02903-4923-
NEXT Oncology /ID# 261601San AntonioTexas78229-

Find similar trials in Duarte, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
City of Hope· Duarte, CAUniv California, San Francisco· San Francisco, CAYale University School of Medicine· New Haven, CTAdventHealth Orlando· Orlando, FLUniversity of Chicago Medical Center· Chicago, ILSTART Midwest· Grand Rapids, MI

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