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NCT06318273 | RECRUITING | Metastatic Castration-Resistant Prostate Cancer

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
Sponsor:

AbbVie

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.

Condition or disease

Metastatic Castration-Resistant Prostate Cancer

Intervention/treatment

ABBV-969

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 140 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-03-08
Estimated Primary Completion Date : 2027-05
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
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

Location Details

NCT06318273

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope /ID# 262059

Duarte, California, United States, 91010

RECRUITING

United States, California

Univ California, San Francisco /ID# 261715

San Francisco, California, United States, 94143-2204

RECRUITING

United States, Connecticut

Yale University School of Medicine /ID# 262234

New Haven, Connecticut, United States, 06510

RECRUITING

United States, Florida

AdventHealth Orlando /ID# 261686

Orlando, Florida, United States, 32803

RECRUITING

United States, Illinois

University of Chicago Medical Center /ID# 261605

Chicago, Illinois, United States, 60637

RECRUITING

United States, Road cancer

START Midwest /ID# 264295

Grand Rapids, Road cancer, United States, 49546

RECRUITING

United States, North Carolina

Carolina BioOncology Institute /ID# 261602

Huntersville, North Carolina, United States, 28078

RECRUITING

United States, Rhode Island

Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687

Providence, Rhode Island, United States, 02903-4923

RECRUITING

United States, Texas

NEXT Oncology /ID# 261601

San Antonio, Texas, United States, 78229

RECRUITING

Australia, New South Wales

Chris O'Brien Lifehouse /ID# 261731

Camperdown, New South Wales, Australia, 2050

RECRUITING

Australia, Victoria

Ballarat Base Hospital /ID# 264294

Ballarat, Victoria, Australia, 3350

RECRUITING

Australia, Victoria

St Vincent's Hospital /ID# 264293

Fitzra, Victoria, Australia, 3065

RECRUITING

Israel, H_EFA

Rambam Health Care Campus /ID# 261770

Haifa, H_efa, Israel, 3525408

RECRUITING

Israel, Tel-Aviv

The Chaim Sheba Medical Center /ID# 261772

Ramat Gain, Tel-Aviv, Israel, 5265601

RECRUITING

Israel,

Hadassah Medical Center-Hebrew University /ID# 261771

Jerusalem, Israel, 91120

RECRUITING

Japan, Chiba

National Cancer Center Hospital East /ID# 261606

Mr. Kashiwa, Chiba, Japan, 277-8577

RECRUITING

Japan, Kyoto

Kyoto University Hospital /ID# 261861

False toshi, Kyoto, Japan, 606-8507

RECRUITING

Japan, Tokyo

National Cancer Center Hospital /ID# 261698

C-Cry, Tokyo, Japan, 104-0045