First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer
Recruiting in Palo Alto (17 mi)
+5 other locations
Overseen ByMark Markowski, MD
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Calibr, a division of Scripps Research
No Placebo Group
Trial Summary
What is the purpose of this trial?CCW702 is an investigational immunotherapy for prostate cancer. This is a two-part, first-in-human study to assess the safety and tolerability of CCW702 administered subcutaneously to patients with metastatic, castration resistant prostate cancer. Part I is divided in to two subparts, in both subparts patients will receive ascending dosages of CCW702 with the goal to determine the maximum tolerated dose (MTD) of CCW702 and efficacious regimen. Part Ia will explore every other other day dosing (QOD); Part Ib will explore weekly dosing (Q7D). In part II of the study, patients will be given the recommended part/phase 2 dose (RP2D) Q7D. The study will also assess the pharmacokinetics and pharmacodynamics of CCW702.
Eligibility Criteria
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention
CCW702 administered subcutaneously Q7D at RP2D.
Group II: Part 1b: Dose Escalation Q7DExperimental Treatment1 Intervention
CCW702 administered subcutaneously Q7D, dose escalating cohorts.
Group III: Part 1a: Dose Escalation QODExperimental Treatment1 Intervention
CCW702 administered subcutaneously QOD, dose escalating cohorts.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Johns Hopkins UniversityBaltimore, MD
Karmanos Cancer InstituteDetroit, MI
Medical College of WisconsinMilwaukee, WI
University of VirginiaCharlottesville, VA
More Trial Locations
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Who is running the clinical trial?
Calibr, a division of Scripps ResearchLead Sponsor