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

Metastatic Castration-Resistant Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318273
• Other study ID #: M24-742
• Status: Recruiting
• Phase: Phase 1
• Start date: March 8, 2024
• Est. completion date: May 27, 2027

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 27, 2027
• Est. primary completion date: May 27, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Castration-Resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• ABBV-969
Intravenous (IV) Infusion

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus /ID# 261770	Haifa	H_efa
Israel	Hadassah Medical Center-Hebrew University /ID# 261771	Jerusalem
Israel	The Chaim Sheba Medical Center /ID# 261772	Ramat Gan	Tel-Aviv
United States	City of Hope /ID# 262059	Duarte	California
United States	START Midwest /ID# 264295	Grand Rapids	Michigan
United States	Carolina BioOncology Institute /ID# 261602	Huntersville	North Carolina
United States	NEXT Oncology /ID# 261601	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.	Up to 3 Years
Primary	Percentage of Participants Achieving Prostate Specific Antigen (PSA) response	PSA response is defined as >= 50% PSA decrease from baseline.	Up to 3 Years
Secondary	Maximum Observed Plasma Concentration (Cmax) of ABBV-969	Cmax is defined as the maximum observed plasma/serum concentration of ABBV-969.	Up to 3 Years
Secondary	Time to Maximum Observed Concentration (Tmax) of ABBV-969	Tmax is defined as the time to maximum observed concentration of ABBV-969.	Up to 3 Years
Secondary	Terminal Phase Elimination Half-Life (t1/2) of ABBV-969	Terminal phase elimination half-life of ABBV-969.	Up to 3 Years
Secondary	Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969	Area under the plasma/serum concentration versus time curve (AUC) of ABBV-969.	Up to 3 Years
Secondary	Antidrug Antibody (ADA)	Incidence and concentration of anti-drug antibodies.	Up to 3 Years
Secondary	Neutralizing Antibodies (nAbs)	Incidence and concentration of neutralizing antibodies.	Up to 3 Years
Secondary	Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase)	The RP2D of ABBV-969 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data.	Up to 2 Years

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