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

NCT04077021 | Terminated Phase 1 FDA Drug

• 1 other identifier: CBR-CCW702-3001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Castration-Resistant Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• 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

  up to day 28

• 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

  up to 2 years

• Part 2: to assess clinical efficacy at the RP2D

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

  up to 2 years

Study Arms (3)

Part 1a: Dose Escalation QOD

EXPERIMENTAL

CCW702 administered subcutaneously QOD, dose escalating cohorts.

Drug: CCW702

Part 1b: Dose Escalation Q7D

EXPERIMENTAL

CCW702 administered subcutaneously Q7D, dose escalating cohorts.

Drug: CCW702

Part 2: Dose Expansion

EXPERIMENTAL

CCW702 administered subcutaneously Q7D at RP2D.

Drug: CCW702

Interventions

CCW702 DRUG

Investigational immunotherapy for prostate cancer

Part 1a: Dose Escalation QOD; Part 1b: Dose Escalation Q7D; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Calibr, a division of Scripps Research: lead

Study Sites (5)

University of California at San Diego

San Diego, California, 92093, United States

Location

Johns Hopkins University - Sydney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• 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.

  PMID: 24127589 BACKGROUND

• 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.

  PMID: 34380625 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: September 4, 2019
• Study Start: July 17, 2020
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)