Back to results

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

Primary Purpose

Metastatic Castration-Resistant Prostate Adenocarcinoma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CCW702

About this trial

This is an interventional treatment trial for Metastatic Castration-Resistant Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University of California at San Diego
Johns Hopkins University - Sydney Kimmel Comprehensive Cancer Center
Karmanos Cancer Institute
University of Virginia
Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Part 1a: Dose Escalation QOD

Part 1b: Dose Escalation Q7D

Part 2: Dose Expansion

Arm Description

CCW702 administered subcutaneously QOD, dose escalating cohorts.

CCW702 administered subcutaneously Q7D, dose escalating cohorts.

CCW702 administered subcutaneously Q7D at RP2D.

Outcomes

Primary Outcome Measures

Part 1a and 1b: Assess the safety and tolerability of CCW702, including incidence of dose limiting toxicities

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

Part 1a and 1b: Select recommended phase/part 2 dose

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

Part 2: to assess clinical efficacy at the RP2D

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04077021

First Posted

August 20, 2019

Last Updated

May 10, 2023

Sponsor

Calibr, a division of Scripps Research

1. Study Identification

Unique Protocol Identification Number

NCT04077021

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

Business decision

Study Start Date

July 17, 2020 (Actual)

Primary Completion Date

October 21, 2022 (Actual)

Study Completion Date

October 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Calibr, a division of Scripps Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Castration-Resistant Prostate Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1a: Dose Escalation QOD

Arm Type

Experimental

Arm Description

CCW702 administered subcutaneously QOD, dose escalating cohorts.

Arm Title

Part 1b: Dose Escalation Q7D

Arm Type

Experimental

Arm Description

CCW702 administered subcutaneously Q7D, dose escalating cohorts.

Arm Title

Part 2: Dose Expansion

Arm Type

Experimental

Arm Description

CCW702 administered subcutaneously Q7D at RP2D.

Intervention Type

Drug

Intervention Name(s)

CCW702

Intervention Description

Investigational immunotherapy for prostate cancer

Primary Outcome Measure Information:

Title

Part 1a and 1b: Assess the safety and tolerability of CCW702, including incidence of dose limiting toxicities

Description

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

Time Frame

up to day 28

Title

Part 1a and 1b: Select recommended phase/part 2 dose

Description

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

Time Frame

up to 2 years

Title

Part 2: to assess clinical efficacy at the RP2D

Description

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

Time Frame

up to 2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of California at San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Johns Hopkins University - Sydney Kimmel Comprehensive Cancer Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24127589

Citation

Kim CH, Axup JY, Lawson BR, Yun H, Tardif V, Choi SH, Zhou Q, Dubrovska A, Biroc SL, Marsden R, Pinstaff J, Smider VV, Schultz PG. Bispecific small molecule-antibody conjugate targeting prostate cancer. Proc Natl Acad Sci U S A. 2013 Oct 29;110(44):17796-801. doi: 10.1073/pnas.1316026110. Epub 2013 Oct 14.

Results Reference

background

PubMed Identifier

34380625

Citation

Lee SC, Ma JSY, Kim MS, Laborda E, Choi SH, Hampton EN, Yun H, Nunez V, Muldong MT, Wu CN, Ma W, Kulidjian AA, Kane CJ, Klyushnichenko V, Woods AK, Joseph SB, Petrassi M, Wisler J, Li J, Jamieson CAM, Schultz PG, Kim CH, Young TS. A PSMA-targeted bispecific antibody for prostate cancer driven by a small-molecule targeting ligand. Sci Adv. 2021 Aug 11;7(33):eabi8193. doi: 10.1126/sciadv.abi8193. Print 2021 Aug.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs