Clinical trial NCT06318273: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Metastatic Castration-Resistant Prostate Cancer
Keywords: Metastatic Castration-Resistant Prostate Cancer
mCRPC
ABBV-969
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-03-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 140 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.
* 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 have refused, 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 phase) suitable for immunohistochemistry (IHC) testing. This requirement may be waived at the discretion of the AbbVie Medical Monitor if collecting a biopsy at screening would place the subject at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator.
* 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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to 3 Years
measure: Percentage of Participants Achieving Prostate Specific Antigen (PSA) response
timeFrame: Up to 3 Years
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of ABBV-969
timeFrame: Up to 3 Years
measure: Time to Maximum Observed Concentration (Tmax) of ABBV-969
timeFrame: Up to 3 Years
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-969
timeFrame: Up to 3 Years
measure: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969
timeFrame: Up to 3 Years
measure: Antidrug Antibody (ADA)
timeFrame: Up to 3 Years
measure: Neutralizing Antibodies (nAbs)
timeFrame: Up to 3 Years
measure: Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase)
timeFrame: Up to 2 Years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope /ID# 262059
state: California
city: San Francisco
country: United States
facility: Univ California, San Francisco /ID# 261715
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine /ID# 262234
state: Connecticut
city: Orlando
country: United States
facility: AdventHealth Orlando /ID# 261686
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center /ID# 261605
state: Illinois
city: Grand Rapids
country: United States
facility: START Midwest /ID# 264295
state: Michigan
city: Huntersville
country: United States
facility: Carolina BioOncology Institute /ID# 261602
state: North Carolina
city: Providence
country: United States
facility: Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687
state: Rhode Island
city: San Antonio
country: United States
facility: NEXT Oncology /ID# 261601
state: Texas
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse /ID# 261731
state: New South Wales
city: Ballarat
country: Australia
facility: Ballarat Base Hospital /ID# 264294
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital /ID# 264293
state: Victoria
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 261770
state: H_efa
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 261772
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 261771
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 261606
state: Chiba
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 261861
state: Kyoto
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 261698
state: Tokyo
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: