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

Sponsor
Calibr, a division of Scripps Research (Other)
Overall Status
Recruiting
CT.gov ID
NCT04077021
Collaborator
(none)
70
Enrollment
5
Locations
3
Arms
40.5
Anticipated Duration (Months)
14
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential 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 :
Jul 17, 2020
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1a: Dose Escalation QOD

CCW702 administered subcutaneously QOD, dose escalating cohorts.

Drug: CCW702
Investigational immunotherapy for prostate cancer
Experimental: Part 1b: Dose Escalation Q7D

CCW702 administered subcutaneously Q7D, dose escalating cohorts.

Drug: CCW702
Investigational immunotherapy for prostate cancer
Experimental: Part 2: Dose Expansion

CCW702 administered subcutaneously Q7D at RP2D.

Drug: CCW702
Investigational immunotherapy for prostate cancer

Outcome Measures

Primary Outcome Measures

  1. Part 1a and 1b: Assess the safety and tolerability of CCW702, including incidence of dose limiting toxicities [up to day 28]

    Frequency, severity, duration of treatment-emergent and treatment-related adverse events per CTCAE v5.0

  2. Part 1a and 1b: Select recommended phase/part 2 dose [up to 2 years]

    Review of safety and tolerability data (adverse events, dosing) based on CTCAE v5 of all Part 1 subjects/cohorts

  3. Part 2: to assess clinical efficacy at the RP2D [up to 2 years]

    Responses will be measured using prostate cancer working group 3 (PCWG3) criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California at San Diego San Diego California United States 92093
2 Johns Hopkins University - Sydney Kimmel Comprehensive Cancer Center Baltimore Maryland United States 21287
3 Karmanos Cancer Institute Detroit Michigan United States 48201
4 University of Virginia Charlottesville Virginia United States 22908
5 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Calibr, a division of Scripps Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Calibr, a division of Scripps Research
ClinicalTrials.gov Identifier:
NCT04077021
Other Study ID Numbers:
  • CBR-CCW702-3001
First Posted:
Sep 4, 2019
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms

Study Results

No Results Posted as of Jul 28, 2022