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Assessing the safety and effects of ABBV-969 in men with advanced prostate cancer

A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer

Phase 1 Interventional AbbVie · NCT06318273

This study is testing a new drug called ABBV-969 to see if it is safe and effective for men with advanced prostate cancer.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment230 (estimated)
Ages18 Years and up
SexMale
SponsorAbbVie Industry-sponsored
Locations26 sites (Duarte, California and 25 other locations)
Trial IDNCT06318273 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, pharmacokinetics, and efficacy of ABBV-969, an investigational drug, in adult participants with metastatic castration-resistant prostate cancer (mCRPC). The trial consists of two parts: an initial dose escalation phase where participants receive varying doses of ABBV-969, followed by a randomized phase to determine the optimal dose for further testing. Approximately 140 participants will be enrolled across multiple sites worldwide, with the study expected to last up to three years.

Who should consider this trial

Good fit: Ideal candidates include adult men diagnosed with metastatic castration-resistant prostate cancer who have progressed on prior hormonal therapies.

Not a fit: Patients who have not received prior novel hormonal agents or taxane treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer who have limited treatment alternatives.

How similar studies have performed: Other studies have explored similar investigational drugs for mCRPC, showing promising results, but the specific approach of ABBV-969 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Duarte, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Castration-Resistant Prostate CancermCRPCABBV-969
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.