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Immunotherapy
First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer
Phase 1
Waitlist Available
Led By Mark Markowski, MD
Research Sponsored by Calibr, a division of Scripps Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new immunotherapy drug for prostate cancer. The goal is to find the maximum tolerated dose and to assess the safety and effectiveness of the drug.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1a and 1b: Assess the safety and tolerability of CCW702, including incidence of dose limiting toxicities
Part 1a and 1b: Select recommended phase/part 2 dose
Part 2: to assess clinical efficacy at the RP2D
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
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Who is running the clinical trial?
Calibr, a division of Scripps ResearchLead Sponsor
6 Previous Clinical Trials
317 Total Patients Enrolled
Mark Markowski, MDPrincipal InvestigatorJohns Hopkins University Hospital - Sidney Kimmel Comprehensive Cancer Center
1 Previous Clinical Trials
12 Total Patients Enrolled