A Phase I Open-label Multi-center Clinical Study to Evaluate Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Anti-Tumor Activity of AC176 in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) Who Have Progressed on at Least Two Prior Systemic Therapies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Metastatic Castration Resistant Prostate Cancer (mcrpc)
  • Age: Between 18 - 100 Years
  • Gender: Male
  • Other Inclusion Criteria:
    In order to participate in the study the following conditions must be met:
    1. Patients with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate excluding neuroendocrine differentiation or small cell features who have had disease progression per 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.
    2. Progressive disease per PCWG3 guidance documented by either: • Positive bone scan (at least 2 new lesions) or metastatic lesions on computed tomography (CT)/magnetic resonance imaging (MRI) that can be followed for response. • If PSA criteria is the only indication of progression, then the PSA values with a starting value of =1.0 ng/mL that have increased on at least 2 occasions obtained a minimum of 1 week apart.
    3. 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.

You may not be eligible for this study if the following are true:

  • You will not be able to participate in the study if you have had:
    1. Treatment with any of the following: • More than 2 lines of chemotherapy • Any systemic anti-cancer therapy chemotherapy or biologic 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
    2. Major surgery (excluding placement of vascular access) within 4 weeks of first dose of study drug.
    3. Known symptomatic brain metastases requiring steroids (above physiologic replacement doses).



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