Trial Title:
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
NCT ID:
NCT06318273
Condition:
Metastatic Castration-Resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Metastatic Castration-Resistant Prostate Cancer
mCRPC
ABBV-969
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABBV-969
Description:
Intravenous (IV) Infusion
Arm group label:
Part 1: ABBV-969 Dose Escalation
Arm group label:
Part 2 A: ABBV-969 Dose Expansion
Arm group label:
Part 2 B: ABBV-969 Dose Expansion
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 120 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope /ID# 262059
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Univ California, San Francisco /ID# 261715
Address:
City:
San Francisco
Zip:
94143-2204
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale University School of Medicine /ID# 262234
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Facility:
Name:
AdventHealth Orlando /ID# 261686
Address:
City:
Orlando
Zip:
32803
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Chicago Medical Center /ID# 261605
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
START Midwest /ID# 264295
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Facility:
Name:
Carolina BioOncology Institute /ID# 261602
Address:
City:
Huntersville
Zip:
28078
Country:
United States
Status:
Recruiting
Facility:
Name:
Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687
Address:
City:
Providence
Zip:
02903-4923
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Oncology /ID# 261601
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Chris O'Brien Lifehouse /ID# 261731
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
Ballarat Base Hospital /ID# 264294
Address:
City:
Ballarat
Zip:
3350
Country:
Australia
Status:
Recruiting
Facility:
Name:
St Vincent's Hospital /ID# 264293
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Chaim Sheba Medical Center /ID# 261772
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Rambam Health Care Campus /ID# 261770
Address:
City:
Haifa
Zip:
3525408
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center-Hebrew University /ID# 261771
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East /ID# 261606
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kyoto University Hospital /ID# 261861
Address:
City:
Kyoto-shi
Zip:
606-8507
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital /ID# 261698
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Start date:
March 8, 2024
Completion date:
May 27, 2027
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06318273
https://www.abbvieclinicaltrials.com/study/?id=M24-742
