for males ages 18-100 (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Principal Investigator
by Rahul Aggarwal
Photo of Rahul Aggarwal
Rahul Aggarwal



This is a non-randomized multi-center Phase 1b/2a dose escalation and dose expansion study involving 85-97 patients testing DKN-01 as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer. Patients need to be biomarker positive (Dickkopf-1 [DKK1]) either in plasma or biopsy. Other biopsies for correlative studies are encouraged but not mandatory. Pharmacokinetic (PK) testing of one pre-treatment blood sample and one post-treatment blood sample will be mandatory on Day 1 of every cycle.


Prostate Cancer Prostatic Neoplasms Docetaxel DKN-01 300 mg DKN-01 600 mg Docetaxel 75 mg/m2 DKN-01 150 mg


You can join if…

Open to males ages 18-100

  • Have a histologically or cytologically confirmed prostate adenocarcinoma or poorly differentiated carcinoma of the prostate
  • Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to C1D1 and must be continued throughout the study.
  • Cohorts 1A, 1B, and 1C. Patients must have received 1 or more androgen receptor (AR) signaling inhibitors (abiraterone or enzalutamide) and have not received prior taxane-based chemotherapy for prostate cancer. Prior treatment with an AR signaling inhibitor for castration-sensitive disease will be allowed if the time to progression was within 1 year after starting drug. Prior treatment with a taxane-based chemotherapy for castration-sensitive disease will be exclusionary.
  • Cohorts 2A and 2B. Patients must have received 1 or more AR signaling inhibitor (abiraterone or enzalutamide) and either had disease progression, were intolerant of, or refused 1 or more taxane-based chemotherapies for mCRPC.
  • Patients must be DKK1-high as determined by either:
  • Elevated DKK1 RNA expression in ≥1% of cells as defined by central laboratory testing of a fresh biopsy or archival specimen OR
  • DKK1 protein level in peripheral blood plasma that is above the reference limit of a cohort of healthy male controls as established by central laboratory testing
  • Cohort 1B. Patients must have progression of measurable disease per mRECIST v1.1 guidelines.
  • Cohort 1C. Patients must have progression of disease defined as one of the following:
  • PSA progression is defined by Prostate Cancer Working Group 3 (PCWG3) criteria as a minimum of two consecutive rising levels, with an interval of ≥1 week between each determination with a minimum PSA of 2 ng/mL.
  • Radionuclide bone progression as defined by at least two new metastatic lesions (per PCWG3).
  • Cohorts 1A, 2A, 2B. Patients must have baseline progression defined as one of the following:
  • PSA progression is defined by PCWG3 criteria as a minimum of two consecutive rising levels, with an interval of ≥1 week between each determination with a minimum PSA of 2 ng/mL.
  • Radionuclide bone progression as defined by at least two new metastatic lesions (per PCWG3).
  • Soft tissue progression on transaxial imaging: new or progressive soft tissue masses on computed tomography (CT) or magnetic resonance imaging (MRI) scans as defined by mRECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Estimated life expectancy of at least 3 months, in the judgment of the Investigator.
  • Disease-free of active second/secondary or prior malignancies for ≥2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast.
  • Required initial laboratory values within 14 days of C1D1:
  • Total bilirubin within normal limits for the institution. (For Cohorts 2A and 2B, total bilirubin < 3 × ULN is acceptable with known liver metastases).
  • Transaminases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)] ≤1.5 × the upper limit of normal (ULN) OR alkaline phosphatase ≤2.5 × ULN (For Cohorts 2A and 2B, AST and ALT and alkaline phosphatase ≤ 5.0 × ULN is acceptable with known liver metastases).
  • Creatinine ≤2.0 or calculated creatinine clearance ≥50 mL/min using the Cockcroft and Gault Method (Cockroft and Gault 1976).
  • Absolute neutrophil count ≥1000 cells/μl.
  • Absolute lymphocyte count ≥500/μl.
  • Hemoglobin ≥9.0 g/dL.
  • Platelet count ≥100,000 cells/μl. (For Cohorts 2A and 2B, Platelet count ≥75,000 cells/μl).
  • International normalized ratio (INR) (prothrombin time [PT])/ partial thromboplastin time (PTT) ≤1.2 × ULN unless receiving anticoagulant, in which case INR ≤3.0 and no active bleeding, (ie, no clinically significant bleeding within 14 days prior to first dose of study therapy.
  • Sexually active male patients must agree to use adequate contraception (hormonal or barrier method of birth control) during the study and for 6 months after their last dose of study drug. Should a patient's partner become pregnant or suspect she is pregnant while participating in the study, the Investigator should be immediately informed.
  • Reliable and willing to make themselves available for the duration of the study and are willing to follow study-specific procedures.
  • Provided written informed consent prior to any study-specific procedures.

You CAN'T join if...

  • Any anti-cancer therapy (with the exception of luteinizing hormonereleasing hormone [LHRH] analog or antagonist) within 2 weeks prior to initiation of study treatment.
  • Any investigational anti-cancer therapy within 4 weeks of initiation of study treatment.
  • Histological small cell or pure neuroendocrine carcinoma that has not yet been treated with at least one line of platinum-based chemotherapy (Prostate adenocarcinoma with immunohistochemical neuroendocrine differentiation but without histological small cell that is naïve to platinumbased chemotherapy will be allowed.)
  • New York Heart Association Class III or IV heart failure, or myocardial infarction within the past 6 months, or unstable arrhythmia within 3 months.
  • Uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry.
  • Known to be human immunodeficiency virus (HIV) positive, have positive hepatitis B surface antigen (HBSAg), or positive hepatitis C antibody (HCAb) test. (Hepatitis C antibody-positive patients with an undetectable hepatitis C virus (HCV) RNA will be eligible.)
  • History of solid organ transplant (ie, heart, lungs, liver, or kidney).
  • History of autologous/allogenic bone marrow transplant.
  • Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator and/or Sponsor.
  • Major surgical procedures or significant traumatic injury within 4 weeks prior to study entry (minor procedures within 1 week of study entry).
  • History of osteonecrosis of the hip. Other hip pathology such as degenerative disease or malignant involvement are not exclusionary. Screening of asymptomatic patients is not required.
  • Active or untreated central nervous system (CNS) malignancy or metastasis. Screening for CNS metastases of asymptomatic patients without a history of CNS metastases is not required. Patients with treated
  • CNS metastases are eligible provided they meet all of the following criteria:
  • Evaluable disease outside the CNS.
  • No history of intracranial or intraspinal hemorrhage.
  • No evidence of significant vasogenic edema.
  • No ongoing requirement for corticosteroids as therapy for CNS disease. (Anti-convulsants at a stable dose for > one month is allowed.)
  • No stereotactic radiation, whole brain radiation within 4 weeks of C1D1.
  • Patients with CNS metastases treated by neurosurgical resection or brain biopsy within 3 month prior to C1D1 will not be allowed.
  • Radiographic demonstration of interim stability (ie, no progression) between completion of CNS-directed therapy and the screening radiographic study.
  • Screening CNS radiographic study ≥4 weeks since completion of radiotherapy or surgical resection and ≥2 weeks since discontinuation of corticosteroids.
  • Any other condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
  • Active substance abuse.
  • Receipt of any live vaccine within 30 days before the first dose of study treatment or anticipation that such a live vaccine will be required during study.
  • Previously treated with an anti-DKK1 therapy.


  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Washington University accepting new patients
    Saint Louis Missouri 63130 United States

Lead Scientist at UCSF

  • Rahul Aggarwal
    I am a Medical Oncologist within the Division of Hematology/Oncology at the University of California San Francisco. My clinical practice focuses on patients with advanced solid tumor malignancies with a particular emphasis on genitourinary malignancies including prostate, kidney, bladder, and testicular cancer. I serve as the Co-Leader for the GU Medical Oncology program at UCSF.


accepting new patients
Start Date
Completion Date
NYU Langone Health
Phase 1/2
Study Type
Last Updated