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
Condition(s) studied
Investigational drug(s) / intervention(s)
ABBV-969: Intravenous (IV) Infusion
Study 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 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
Primary outcome measure(s)
- 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. - Percentage of Participants Achieving Prostate Specific Antigen (PSA) response — Up to 3 Years
PSA response is defined as \>= 50% PSA decrease from baseline.
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope /ID# 262059 | Duarte | California | |
| Univ California, San Francisco /ID# 261715 | San Francisco | California | |
| Yale University School of Medicine /ID# 262234 | New Haven | Connecticut | |
| AdventHealth Orlando /ID# 261686 | Orlando | Florida | |
| University of Chicago Medical Center /ID# 261605 | Chicago | Illinois | |
| START Midwest /ID# 264295 | Grand Rapids | Michigan | |
| Carolina BioOncology Institute /ID# 261602 | Huntersville | North Carolina | |
| Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687 | Providence | Rhode Island | |
| NEXT Oncology /ID# 261601 | San Antonio | Texas | |
| Chris O'Brien Lifehouse /ID# 261731 | Camperdown | New South Wales | |
| Ballarat Base Hospital /ID# 264294 | Ballarat | Victoria | |
| St Vincent's Hospital /ID# 264293 | Fitzroy | Victoria | |
| Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 270890 | Montreal | Quebec | |
| McGill University Health Centre - Glen Site. /ID# 271275 | Montreal | Quebec | |
| Centre Oscar Lambret /ID# 270602 | Lille | Nord | |
| Centre Leon Berard /ID# 270605 | Lyon | Rhone | |
| Institut Gustave Roussy /ID# 270603 | Villejuif | Île-de-France Region | |
| The Chaim Sheba Medical Center /ID# 261772 | Ramat Gan | Tel Aviv | |
| Rambam Health Care Campus- Haifa /ID# 261770 | Haifa | Israel | |
| Hadassah Medical Center-Hebrew University /ID# 261771 | Jerusalem | Israel | |
| National Cancer Center Hospital East /ID# 261606 | Kashiwa-shi | Chiba | |
| Kyoto University Hospital /ID# 261861 | Kyoto | Kyoto | |
| National Cancer Center Hospital /ID# 261698 | Chuo-ku | Tokyo | |
| Hospital Universitario Vall de Hebron /ID# 270889 | Barcelona | Spain | |
| Hospital Universitario HM Sanchinarro /ID# 271345 | Madrid | Spain | |
| Hospital Universitario Virgen del Rocio /ID# 270617 | Seville | Spain |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06318273 on ClinicalTrials.gov ↗ ← All trials in Spain