NCT06318273Active, not recruitingPhase 1
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
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 152 (actual)
- First submitted
- 13 Mar 2024
- Start date
- 8 Mar 2024
- Primary completion date
- May 2027
- Lead sponsor
- AbbVie
- Diseases
- Prostate cancer
- NCT number
- NCT06318273
- EU CT number
- 2024-516772-15-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 152
- From 8 Mar 2024 to the primary completion date, May 2027
- 27 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
- 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.
Other illness
- History of other active malignancy, as laid out in the protocol.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ballarat Base Hospital /ID# 264294 Coordinator of this site? Confirm its status | Ballarat | Australia | Unknown status |
| Chris O'Brien Lifehouse /ID# 261731 Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| St Vincent's Hospital /ID# 264293 Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 270890 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill University Health Centre - Glen Site. /ID# 271275 Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| Mater Misericordiae University Hospital Coordinator of this site? Confirm its status | Dublin 7 | Ireland | Not yet recruiting |
| Rambam Health Care Campus- Haifa /ID# 261770 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center-Hebrew University /ID# 261771 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| The Chaim Sheba Medical Center /ID# 261772 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| National Cancer Center Hospital /ID# 261698 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| National Cancer Center Hospital East /ID# 261606 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Kyoto University Hospital /ID# 261861 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| University of Chicago Medical Center /ID# 261605 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| City of Hope /ID# 262059 Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| START Midwest /ID# 264295 Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Carolina BioOncology Institute /ID# 261602 Coordinator of this site? Confirm its status | Huntersville | United States | Unknown status |
| Yale University School of Medicine /ID# 262234 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| AdventHealth Orlando /ID# 261686 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687 Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| NEXT Oncology /ID# 261601 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Univ California, San Francisco /ID# 261715 Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.