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Metastatic Castration-resistant Prostate CancerPhase 1NCT05156905

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

A Phase 1 study testing Cirmtuzumab in people with Metastatic Castration-resistant Prostate Cancer, run by University of California, San Diego at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Cirmtuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
16 Jun 2022to 1 Oct 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California San Diego

    La Jolla, California, 92037

Other trials in United States

About this study

Official title: A Phase 1b Trial Investigating Docetaxel Combined with Cirmtuzumab in Patients with Metastatic Castration Resistant Prostate Cancer

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.

Read the detailed description

This study seeks to targeting the non-canonical Wnt pathway with an antibody against ROR1. ROR1 is an attractive target given its low expression in non-malignant tissues and its role in proliferation and survival in prostate cancer. From preclinical data in a variety of tumor types, blockade of ROR1 inhibits cell growth and cirmtuzumab has shown efficacy in clinical trials with CLL. Preclinical data suggests that ROR1 is upregulated in chemotherapy resistant cells and treatment with cirmtuzumab and a taxane achieved higher cytotoxic response than both agents alone, supporting the use of the combination of cirmtuzumab and a taxane. Based on the biological rationale behind cirmtuzumab and preclinical activity with docetaxel, this is an open label, phase 2 clinical trial to evaluate the safety and efficacy of cirmtuzumab in combination with docetaxel for the treatment of metastatic, castrate resistant prostate adenocarcinoma.

Being tested
Cirmtuzumab
Keywords
Prostate cancer, Docetaxel, Wnt pathway, Cirmtuzumab, ROR1
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CirmtuzumabDrug

    Also called Docetaxel

    Cirmtuzumab will be given in combination with docetaxel.

Study groups in NCT05156905
Study groupRoleWhat they receive
Cirmtuzumab + DocetaxelExperimentalThere 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.
Receives: Drug: Cirmtuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended phase 2 dose of docetaxel combined with cirmtuzumab

    Defined by CTCAE version 5 grading

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

Secondary outcomes (9)

  1. Incidence of treatment-emergent adverse events

    Defined by CTCAE version 5 grading

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

  2. Total alkaline phosphatase response

    Defined as a reduction of ≥30% from the baseline value, confirmed ≥4 weeks later.

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

  3. Time to PSA progression

    Defined by PCWG-3 criteria

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

  4. Time to increase in the total alkaline phosphatase level

    Defined as an increase of ≥25% from baseline at ≥12 weeks, in patients with no decrease from baseline, or as an increase of ≥25% above the nadir, confirmed ≥3 weeks later, in patients with an initial decrease from baseline.

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

  5. Radiographic progression free survival

    Defined by PCWG-3 criteria for bone metastases and RECIST version 1.1 for soft tissue

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

  6. Time to first subsequent anti-cancer therapy

    Time from study discontinuation to initiation of subsequent systemic anti-cancer therapy or death

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

  7. Time to first symptomatic skeletal event

    Time to first symptomatic pathologic fracture, radiation to the bone given symptomatic bone metastasis, surgery to the bone given symptomatic bone metastasis, or symptomatic spinal cord compression

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

  8. Overall survival

    Time from enrollment to death or last follow up

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

  9. Composite clinical benefit

    Composite endpoint of clinical benefit defined as any one of the following: PSA response by PCWG3 criteria, objective response rate by RECIST version 1.1, and stable disease > 6 months by RECIST version 1.1.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start16 Jun 2022
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Why it stopped: Oncternal closing clinical trial operations.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05156905
Sponsor's protocol ID
19-1514
Status last verified
Oct 2024
First submitted
1 Dec 2021
Last updated
9 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cirmtuzumab in people with Metastatic Castration-resistant Prostate Cancer, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Oncternal closing clinical trial operations.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended phase 2 dose of docetaxel combined with cirmtuzumab (time frame: Patients will be followed from study entry to death or date last known alive, assessed up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05156905.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.

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