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

Phase 1

Not yet recruiting

• Conditions: Prostate Cancer; Metastatic Castration-Resistant Prostate Cancer
• Interventions: Drug: ABBV-969

• Registration Number: 2024-516772-15-00
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-27

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1: ABBV-969 Dose Escalation	ABBV-969	Participants will receive escalating doses of ABBV-969.
Part 2 A: ABBV-969 Dose Expansion	ABBV-969	Participants will receive dose A of ABBV-969 from part 1.
Part 2 B: ABBV-969 Dose Expansion	ABBV-969	Participants will receive dose B of ABBV-969 from part 1.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Prostate Specific Antigen (PSA) response	Up to 3 Years	PSA response is defined as \>= 50% PSA decrease from baseline.
Percentage of Participants With Adverse Events (AEs)	Up to 3 Years	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.

Secondary Outcome Measures

Name	Time	Method
Antidrug Antibody (ADA)	Up to 3 Years	Incidence and concentration of anti-drug antibodies.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-969	Up to 3 Years	Terminal phase elimination half-life of ABBV-969.
Maximum Observed Plasma Concentration (Cmax) of ABBV-969	Up to 3 Years	Cmax is defined as the maximum observed plasma/serum concentration of ABBV-969.
Neutralizing Antibodies (nAbs)	Up to 3 Years	Incidence and concentration of neutralizing antibodies.
Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase)	Up to 2 Years	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.
Time to Maximum Observed Concentration (Tmax) of ABBV-969	Up to 3 Years	Tmax is defined as the time to maximum observed concentration of ABBV-969.
Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969	Up to 3 Years	Area under the plasma/serum concentration versus time curve (AUC) of ABBV-969.

Trial Locations

Locations (6)

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Leon Berard; 🇫🇷 Lyon, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Hospital Universitari Vall D Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Hm Sanchinarro; 🇪🇸 Madrid, Spain

University Hospital Virgen Del Rocio S.L.; 🇪🇸 Sevilla, Spain

Centre Oscar Lambret

🇫🇷Lille, France

Aurélien CARNOT

Site contact

+33320295959

a-carnot@o-lambret.fr