Study of Docetaxel Combined with Cirmtuzumab in Metastatic Castration Resistant Prostate Cancer

NCT05156905 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 19-1514
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the safety and efficacy of cirmtuzumab in combination with standard of care docetaxel in patients with metastatic castration resistant prostate cancer. Docetaxel is a taxane chemotherapy which has been shown to prolong survival in men with castration resistant prostate cancer. Cirmtuzumab is a monoclonal antibody that targets the receptor called ROR1 of the non-canonical Wnt pathway and is suspected to contribute to prostate cancer growth and progression.

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

Prostate cancer; Docetaxel; Wnt pathway; Cirmtuzumab; ROR1

Outcome Measures

Primary Outcomes (1)

• Recommended phase 2 dose of docetaxel combined with cirmtuzumab

  Defined by CTCAE version 5 grading

  Patients will be followed from study entry to death or date last known alive, assessed up to 36 months

Secondary Outcomes (9)

• Incidence of treatment-emergent adverse events

  Patients will be followed from study entry to death or date last known alive, assessed up to 36 months

• Total alkaline phosphatase response

  Patients will be followed from study entry to death or date last known alive, assessed up to 36 months

• Time to PSA progression

  Patients will be followed from study entry to death or date last known alive, assessed up to 36 months

• Time to increase in the total alkaline phosphatase level

  Patients will be followed from study entry to death or date last known alive, assessed up to 36 months

• Radiographic progression free survival

  Patients will be followed from study entry to death or date last known alive, assessed up to 36 months

Study Arms (1)

Cirmtuzumab + Docetaxel

EXPERIMENTAL

There is only one treatment arm on this study. The combination of cirmtuzumab + docetaxel will be administered on one treatment arm. Treatment will cirmtuzumab will be administered initially as a loading dose alone on days 1, 15, and 29 of cycle 1. Following the loading, cirmtuzumab will be given on Day 1 of every 21-day cycle starting on Cycle 2 to up to Cycle 7 corresponding with concurrent docetaxel administration. Following discontinuation or completion of docetaxel, treatment with cirmtuzumab will be continued Day 1 of every 28 cycle until disease progression, toxicity or study withdrawal. Docetaxel will be administered on day 1 of every 21-day cycle starting Cycle 2 for up to 6 cycles.

Drug: Cirmtuzumab

Interventions

Cirmtuzumab DRUG

Cirmtuzumab will be given in combination with docetaxel.

Also known as: Docetaxel

Cirmtuzumab + Docetaxel

Eligibility Criteria

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

You may qualify if:

• Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate. Patients with neuroendocrine component are eligible.
• Participants must have castrate levels of serum testosterone \< 50 ng/dL.
• Participants without orchiectomy must be maintained on luteinizing hormone releasing hormone (LHRH) agonist/antagonist.
• Participants must have received prior abiraterone and/or next generation androgen receptor antagonist (enzalutamide, apalutamide, or darolutamide) for hormone sensitive disease or CRPC. Prior docetaxel for hormone sensitive disease is permitted.
• Participants must have progressive disease. Patients with non-measurable disease are eligible.
• Eastern Cooperative Oncology Group performance status ≤1 (Karnofsky ≥80%).
• Patients must have normal organ and marrow function.

You may not qualify if:

• No pure small cell carcinoma.
• Prior treatment with cirmtuzumab.
• No prior treatment with docetaxel for CRPC.
• Treatment with abiraterone, apalutamide, or darolutamide within 2 weeks of treatment initiation. Treatment with cytotoxic chemotherapy within 3 weeks of treatment initiation. Treatment enzalutamide or other investigational prostate cancer directed therapy within 4 weeks of treatment initiation.
• Palliative radiation therapy to the bone or other sites within 2 weeks of treatment initiation.
• Imminent or established spinal cord compression based on clinical and/or imaging findings.
• Known active central nervous system metastases and/or carcinomatous meningitis.
• Uncontrolled intercurrent illness or clinically significant medical condition.
• Treatment with antimicrobial agent within 4 weeks of treatment initiation.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cirmtuzumab; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Rana McKay

  UCSD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Urology

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: June 16, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)