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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
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

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ballarat Base Hospital /ID# 264294
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BallaratAustraliaUnknown status
Chris O'Brien Lifehouse /ID# 261731
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CamperdownAustraliaUnknown status
St Vincent's Hospital /ID# 264293
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FitzroyAustraliaUnknown status
Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 270890
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
McGill University Health Centre - Glen Site. /ID# 271275
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MontrealCanadaUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario HM Sanchinarro
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MadridSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Centre Oscar Lambret
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LilleFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
Mater Misericordiae University Hospital
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Dublin 7IrelandNot yet recruiting
Rambam Health Care Campus- Haifa /ID# 261770
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HaifaIsraelUnknown status
Hadassah Medical Center-Hebrew University /ID# 261771
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JerusalemIsraelUnknown status
The Chaim Sheba Medical Center /ID# 261772
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Ramat GanIsraelUnknown status
National Cancer Center Hospital /ID# 261698
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Chuo-kuJapanUnknown status
National Cancer Center Hospital East /ID# 261606
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Kashiwa-shiJapanUnknown status
Kyoto University Hospital /ID# 261861
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KyotoJapanUnknown status
University of Chicago Medical Center /ID# 261605
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ChicagoUnited StatesUnknown status
City of Hope /ID# 262059
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DuarteUnited StatesUnknown status
START Midwest /ID# 264295
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Grand RapidsUnited StatesUnknown status
Carolina BioOncology Institute /ID# 261602
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HuntersvilleUnited StatesUnknown status
Yale University School of Medicine /ID# 262234
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New HavenUnited StatesUnknown status
AdventHealth Orlando /ID# 261686
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OrlandoUnited StatesUnknown status
Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687
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ProvidenceUnited StatesUnknown status
NEXT Oncology /ID# 261601
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San AntonioUnited StatesUnknown status
Univ California, San Francisco /ID# 261715
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San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.