NCT04077021

First-in-human Study of CCW702 in Patients With Metastatic Castration Resistant Prostate Cancer

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Calibr, a division of Scripps Research · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metastatic Castration-Resistant Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	CCW702	Investigational immunotherapy for prostate cancer

Timeline

• Start date: 2020-07-17
• Primary completion: 2022-10-21
• Completion: 2022-10-21
• First posted: 2019-09-04
• Last updated: 2023-05-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study