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Metastatic Castration Resistant Prostate CancerPhase 1NCT05241613

A Study of AC176 for the Treatment of Metastatic Castration Resistant Prostate Cancer

A Phase 1 study testing AC176 in people with Metastatic Castration Resistant Prostate Cancer, run by Accutar Biotechnology Inc at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This clinical trial is evaluating a drug called AC176 in participants with metastatic castration resistant prostate cancer (mCRPC) who have progressed on at least two prior systemic therapies. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
AC176
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
5 sitesUnited States
Study dates
16 Mar 2022to 5 Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males who are at least 18 years-of-age at the time of signature of the informed consent form (ICF)
  • Patients with histological, pathological, or cytological confirmed diagnosis of advanced or mCRPC who have had disease progression per Prostate Cancer Working Group 3(PCWG3) guidance following standard treatment, including approved taxane-based chemotherapy, or who are not amenable (intolerability, patient choice) to standard therapies, or for whom no therapy of proven efficacy exists.
  • Advanced or metastatic disease per PCWG3 guidance documented by either:
  • Positive bone scan (2 lesions) or metastatic lesions on computed tomography (CT)/magnetic resonance imaging (MRI) that can be followed for response.
  • Or
  • Prostate-specific antigen (PSA) values with a starting value of ≥1.0 ng/mL that have increased on 3 occasions obtained a minimum of 1 week apart.
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  • Patients must have progressed on at least 2 prior approved systemic therapies (in any setting), with at least 1 being abiraterone, or enzalutamide, or apalutamide or darolutamide
  • Patients who have had surgical or medical castration.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1
  • Life expectancy ≥3 months after the start of the treatment according to the Investigator's judgment

Who cannot join

  • Patients who meet any of the following criteria will be excluded from study entry:
  • Treatment with any of the following:
  • More than 2 lines of chemotherapy
  • Any systemic anti-cancer therapy, chemotherapy, biologic, or hormonal agent from a previous treatment regimen or clinical study within 4 weeks prior to the first dose of study drug. Any systemic small molecules from a previous treatment regimen or clinical study within 2 weeks or 5 half-lives (whichever is longer, not to exceed 4 weeks) prior to the first dose of study drug, except ADT for medical castration purpose.
  • Any investigational agents from a previous clinical study within 4 weeks prior to the first dose of study treatment
  • Radiation therapy (including therapeutic radioisotopes) within 4 weeks prior to first dose of study drug. Radiation for palliation within 2 weeks of study drug. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study
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  • With the exception of alopecia and ≤ Grade 2 peripheral neuropathy, any unresolved toxicities from prior therapy greater than the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 1 at the time of starting study treatment. Note: subjects with chronic Grade 2 toxicities that are asymptomatic or adequately managed with stable medication may be eligible with Sponsor approval
  • Major surgery (excluding placement of vascular access) within 4 weeks of first dose of study drug.
  • Known symptomatic brain metastases requiring steroids (above physiologic replacement doses)
  • Men who plan to father a child while in the study or within 90 days after the last administration of study treatment
  • Any condition that impairs a patient's ability to swallow whole pills. Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of AC176 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea Grade ≥2, malabsorption syndrome)
  • Any of the following cardiac criteria experienced currently or within the last 6 months:
  • Mean resting corrected QT interval (QTc) >470 msec
  • Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block
  • Congestive heart failure (New York Heart Association ≥ Grade 2)
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval
  • Left ventricular ejection fraction (LVEF) <50% or the lower limit of normal of the institutional standard.
  • As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection. Screening for chronic conditions is not required. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Site 04

    Dallas, Texas, 75230

  • Site 02

    Denver, Colorado, 80218

  • Site 05

    Detroit, Michigan, 48201

  • Site 01

    Nashville, Tennessee, 37203

  • Site 03

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: A Phase I Study to Evaluate Safety, Tolerability, PK, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC176 in Patients With Metastatic Castration Resistant Prostate Cancer Who Have Progressed on at Least Two Prior Systemic Therapies

This clinical trial is evaluating a drug called AC176 in participants with metastatic castration resistant prostate cancer (mCRPC) who have progressed on at least two prior systemic therapies.

The main goals of this study are to:

  • Identify the recommended dose of AC176 that can be given safely to participants
  • Evaluate the side effects of AC176
  • Evaluate pharmacokinetics of AC176
  • Evaluate the effectiveness of AC176
Read the detailed description

AC176-001 is a Phase I, first-in-human, open-label, multi-center dose-escalation study of AC176 given as a single agent. The AC176 is an investigational medicinal product that is a potent orally bioavailable Androgen Receptor (AR) degrader studied for the treatment of Metastatic Castration Resistant Prostate Cancer.

Being tested
AC176
Keywords
mCRPC, Androgen Receptor, AC176, Phase I, Androgen Receptor Degrader, First in Human
Medical subject headings
Bulbo-Spinal Atrophy, X-Linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AC176Drug

    AC176 will be given orally (PO) on a 28-day cycle.

Study groups in NCT05241613
Study groupRoleWhat they receive
AC176 Dose Escalation as Single AgentExperimentalSingle agent dose escalation of AC176. AC176 will be given orally (PO) on a 28-day cycle.
Receives: Drug: AC176

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicities (DLTs) from AC176 monotherapy

    Number of subjects with DLT

    Measured: 28 days

  2. Adverse events (AEs)/Serious adverse events (SAEs)

    Number of adverse events as characterized by type, frequency, seriousness, and relationship to AC176

    Measured: Through study completion, approximately 24 months

  3. Number of patients with vital signs abnormalities

    Vital signs abnormalities as characterized by type, frequency, severity and timing

    Measured: Through study completion, approximately 24 months

  4. Incidence of laboratory abnormalities as a measure of safety and tolerability of AC176

    Laboratory abnormalities as characterized by type, frequency, severity and timing

    Measured: Through study completion, approximately 24 months

  5. Incidence of Electrocardiogram (ECG) abnormalities as a measure of safety and tolerability of AC176

    Electrocardiogram (ECG) abnormalities such as heart rate, QTcF, PR, RR and QRS intervals

    Measured: Through study completion, approximately 24 months

Secondary outcomes (9)

  1. Prostate-Specific Antigen (PSA) response rate

    PSA response rate per PCWG3

    Measured: Throughout the study, approximately 24 months

  2. Title: Duration of Response (DoR)

    Measured: Throughout the study, approximately 24 months

  3. Objective Response Rate(ORR)

    Measured: Throughout the study, approximately 24 months

  4. Time-to-Progression (TTP)

    Measured: Throughout the study, approximately 24 months

  5. Pharmacokinetic Analysis: area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))

    Measured: 20 weeks

  6. Pharmacokinetic Analysis: area under the concentration-time curve over the dosing interval (AUC(0-tau))

    Measured: 20 weeks

  7. Pharmacokinetic Analysis: maximum plasma concentration (Cmax)

    Measured: 20 weeks

  8. Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)

    Measured: 20 weeks

  9. Pharmacokinetic Analysis: terminal elimination half life (t1/2)

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2022
  2. Study start16 Mar 2022
  3. Primary completion5 Mar 2024
  4. Study completion5 Mar 2024

Why it stopped: Subject benefit-risk ratio changes, sponsor decides to voluntarily terminate study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05241613
Sponsor's protocol ID
AC176-001
Status last verified
Feb 2025
First submitted
17 Jan 2022
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AC176 in people with Metastatic Castration Resistant Prostate Cancer, run by Accutar Biotechnology Inc at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Subject benefit-risk ratio changes, sponsor decides to voluntarily terminate study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (DLTs) from AC176 monotherapy (time frame: 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05241613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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