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NCT06318273 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by AbbVie.

Recruiting
Registry status
Phase 1
Development phase
140
Enrollment target
20
Study locations

NCT06318273 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by AbbVie. The registered enrollment target is 140 participants, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT06318273, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 1
Development phase
140 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Metastatic Castration-Resistant Prostate Cancer

Interventions

  • DRUG ABBV-969

Study Locations (20)

California

  • City of Hope /ID# 262059 - Duarte
  • Univ California, San Francisco /ID# 261715 - San Francisco

Victoria

  • Ballarat Base Hospital /ID# 264294 - Ballarat
  • St Vincent's Hospital /ID# 264293 - Fitzroy

Quebec

  • Centre Hospitalier de l'Université de Montréal (CHUM) /ID# 270890 - Montreal
  • McGill University Health Centre - Glen Site. /ID# 271275 - Montreal

Other

  • Rambam Health Care Campus- Haifa /ID# 261770 - Haifa
  • Hadassah Medical Center-Hebrew University /ID# 261771 - Jerusalem

Connecticut

  • Yale University School of Medicine /ID# 262234 - New Haven

Florida

  • AdventHealth Orlando /ID# 261686 - Orlando

Illinois

  • University of Chicago Medical Center /ID# 261605 - Chicago

Michigan

  • START Midwest /ID# 264295 - Grand Rapids

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2024-03-08
Est. Completion 2027-05
Phase Phase 1

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06318273

The ClinicalTrials.gov registry entry for NCT06318273 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (29% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which ABBV-969 is the first listed.

NCT06318273 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Victoria, Quebec.

Frequently Asked Questions

What is clinical trial NCT06318273 about?

NCT06318273 is a clinical study titled "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". 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 ...

What is the current status of trial NCT06318273?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2024-03-08. Estimated completion is 2027-05.

What conditions does trial NCT06318273 study?

This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.

What interventions are being tested in trial NCT06318273?

The interventions under investigation include: ABBV-969 (DRUG).

Who is sponsoring clinical trial NCT06318273?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06318273 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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