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

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Metastatic Castration-Resistant Prostate Cancer

Treatments: Drug: ABBV-969

Study type: Interventional

Funder types: Industry

Identifiers

NCT06318273

2024-516772-15-00 (Other Identifier)

M24-742

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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230 participants in 3 patient groups

Part 1: ABBV-969 Monotherapy Dose Escalation

Experimental group

Description:

Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive ABBV-969 monotherapy once every 21 days

Treatment:

Drug: ABBV-969

Part 2 A: Monotherapy Dose Expansion/Dose Optimization

Experimental group

Description:

Participants with mCRPC will receive dose A of ABBV-969 (dose levels determined in Part 1) for dose optimization.

Treatment:

Drug: ABBV-969

Part 2 B: Monotherapy Dose Expansion/Dose Optimization

Experimental group

Description:

Participants with mCRPC will receive Dose B of ABBV-969 (dose levels determined in Part 1) for dose optimization.

Treatment:

Drug: ABBV-969