First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04077021 |
Recruitment Status :
Recruiting
First Posted : September 4, 2019
Last Update Posted : October 4, 2021
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Condition or disease | Intervention/treatment | Phase |
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Castration-Resistant Prostatic Cancer | Drug: CCW702 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open-label Study in Two Parts, Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of CCW702 in Patients With Metastatic, Castration Resistant Prostate Adenocarcinoma |
Actual Study Start Date : | July 17, 2020 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | December 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Part 1: Dose Escalation
CCW702 is administered subcutaneously with ascending dose levels to determine maximal tolerated dose (MTD).
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Drug: CCW702
Investigational immunotherapy for prostate cancer |
Experimental: Part 2: Dose Expansion
CCW702 is administered subcutaneously at the recommended phase 2 dose (RP2D). Different dosing regimens will be compared.
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Drug: CCW702
Investigational immunotherapy for prostate cancer |
- Part 1, Dose escalation: to assess the safety and tolerability of increasing doses of CCW702: number of first cycle dose limiting toxicities [ Time Frame: up to 4 weeks ]Measure the number of first cycle dose limiting toxicities
- Part 2, Dose expansion: to assess clinical efficacy at the recommended phase 2 dose. [ Time Frame: up to 2 years ]Responses will be measured using prostate cancer working group 3 (PCWG3) criteria

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men ≥ 18 years of age at time of informed consent
- For Part 1 and Part 2: men with metastatic castration resistant prostate cancer (mCRPC) with histologically or cytologically confirmed adenocarcinoma of the prostate as defined by one or more of the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
- Patients with treated brain metastasis or LMD are eligible if brain imaging shows no evidence of progression
- Must have prostate-specific antigen (PSA) and/or radiographic progression on AT LEAST One novel androgen receptor (AR)-targeted therapy (abiraterone acetate, enzalutamide).
- Eastern Cooperative Oncology Group performance status of 0-1
- Adequate liver function
- Adequate hematopoietic function
- Testosterone level ≤ 50 ng/mL (or 1.73 nmol/L)
- Patient has a life expectancy of greater than 12 weeks
Exclusion Criteria:
- Patients whose tumors solely exhibit neuroendocrine differentiation or small cell features by histopathology
- Patients with new or progressive brain metastasis or Leptomeningeal Disease (LMD)
- Patients with a history of clinically significant cardiovascular disease such as symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, history of stroke or myocardial infarction within 6 months of enrollment
- Patients with peripheral neuropathy CTCAE Grade >/= 2
- Patients with a known history of hypersensitivity, allergy or intolerance to CCW702 or its excipients
- Patients with untreated or imminent spinal cord compression

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077021
Contact: Travis Young, Ph.D | 858-242-1045 | youngtr@scripps.edu |
United States, California | |
University of California at San Diego | Recruiting |
San Diego, California, United States, 92093 | |
Contact: Arlene Araneta 858-822-5374 aaraneta@health.ucsd.edu | |
Principal Investigator: Rana McKay, MD | |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Richard Zak 410-502-4910 rzak5@jhmi.edu | |
Contact: Amber Michalik 410-502-0756 amichal2@jhmi.edu | |
Principal Investigator: Mark Markowski, MD, PhD | |
United States, Michigan | |
Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Hannah Cressman 313-576-8387 cressmanh@karmanos.org | |
Principal Investigator: Elisabeth Heath, MD | |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Jennifer Drake 434-297-7782 jd4cx@virginia.edu | |
Contact: Milos Lesevic 434-243-0544 ml4ec@virginia.edu | |
Principal Investigator: Robert Dreicer, MD | |
United States, Wisconsin | |
Medical College of Wisconsin | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Holly Lemke 414-805-0261 hlemke@mcw.edu | |
Principal Investigator: Deepak Kilari, MD |
Principal Investigator: | Mark Markowski, MD | Johns Hopkins University Hospital - Sidney Kimmel Comprehensive Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Calibr, a division of Scripps Research |
ClinicalTrials.gov Identifier: | NCT04077021 |
Other Study ID Numbers: |
CBR-CCW702-3001 |
First Posted: | September 4, 2019 Key Record Dates |
Last Update Posted: | October 4, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |