Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06318273
Study type Interventional
Source AbbVie
Contact ABBVIE CALL CENTER
Phone 844-663-3742
Email abbvieclinicaltrials@abbvie.com
Status Recruiting
Phase Phase 1
Start date March 8, 2024
Completion date May 27, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT04986423 - ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT05489991 - A Study of TmPSMA-02 Chimeric Antigen Receptor (CAR) T-cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Phase 1/Phase 2
Active, not recruiting NCT05521412 - EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T Phase 1/Phase 2
Terminated NCT04556617 - PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Phase 1/Phase 2
Completed NCT02125357 - Sequencing Abiraterone and Enzalutamide in mCRPC Phase 2
Recruiting NCT06052306 - A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Men With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC) Phase 1
Recruiting NCT05917470 - A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer. Phase 1/Phase 2
Recruiting NCT05519449 - Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) Phase 1
Terminated NCT05301062 - A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
Recruiting NCT05383079 - Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men With Metastatic Castration-Resistant Prostate Cancer Phase 1/Phase 2
Active, not recruiting NCT04060394 - Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC Phase 1/Phase 2
Completed NCT01942837 - Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer Phase 2
Recruiting NCT05458544 - [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application Phase 1/Phase 2
Withdrawn NCT04879589 - Phase 1 Study of ATRS-2002 in Healthy Male Adults Phase 1
Recruiting NCT03230734 - Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer Phase 2
Recruiting NCT05116579 - Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)
Active, not recruiting NCT03732820 - Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer Phase 3
Recruiting NCT05005728 - XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer Phase 2
Recruiting NCT05762536 - Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC Phase 2