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Prostate Cancer Metastatic Castration-ResistantPhase 1NCT07866300

A Study of KMV002 in Patients With mAPMR Prostate Cancer

A Phase 1 study testing KMV002 in people with Prostate Cancer Metastatic Castration-Resistant, run by Chimivac INC at 2 sites in Australia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a first-in-human (FIH) open-label, multicenter, dose-escalation and dose-expansion Phase I study of KMV002 in metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer patients. This study consists of two parts: dose escalation (Part 1) and dose expansion (Part 2). Read more about this study

Who is it for?
Ages 18 to 80 years, men only
What is being tested?
KMV002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesAustralia
Study dates
Nov 2026to Sep 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male, age 18 to 80 years, inclusive.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted, provided that usual adenocarcinoma is the predominant component (a known subset may be acceptable). However, pure small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed.
  • Androgen pathway modulation-resistant disease, defined as disease progression while receiving ongoing androgen pathway modulation (e.g., androgen deprivation therapy [ADT], androgen receptor pathway inhibitors [ARPIs]). Disease progression may be documented by PSA progression, radiographic progression, consistent with PCWG4 principles and investigator judgment, in consultation with the Medical Monitor where appropriate.
  • All participants must have received (and be receiving) standard of care androgen deprivation treatment (surgical castration versus GnRH analogue or antagonist treatment); participants receiving GnRH analogue or antagonist must continue this treatment throughout the time on this study. Participants must have a castrate serum level of testosterone (< 50 ng/dL or 1.7 nmol/L) at screening.
  • Disease progression must be documented based on available clinical evidence and investigator judgment and may be established using any one of the following criteria, as applicable:
  • PSA progression: PSA level increase from baseline / nadir, with a minimum rise of 0.2 ng/mL, confirmed by an additional rising PSA measurement performed. Alternative documentation of progression may be accepted following discussion with the Medical Monitor when confirmation is not feasible or may unnecessarily delay treatment.
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  • Soft tissue / Visceral progression (lymph nodes, lung, liver, other viscera, prostate/prostate bed): Assessed according to RECIST 1.1.
  • Bone progression: As defined by PCWG4 criteria, two or more new lesions will constitute progression in bone. PSMA PET is not required for bone progression assessment.
  • Metastatic disease as evidenced by soft tissue lesions on baseline computed tomography (CT) scan / magnetic resonance imaging (MRI) of the chest, abdomen and pelvis, and/or bone metastases on baseline bone scan.
  • Asymptomatic or minimally symptomatic mAPMR. "Asymptomatic/minimally symptomatic" is defined by meeting all of the following criteria:
  • Controlled symptoms (e.g., opioids for cancer related pain stable for > 4 weeks, no need for urgent radiotherapy for symptomatic lesions).
  • No anticipated need for immediate alternative systemic therapy (e.g., taxane chemotherapy, olaparib, Lu-PSMA) to manage symptomatic progression in the judgment of the investigator.
  • Prior stereotactic ablative radiotherapy (SABR) is not required. If prior SABR has been received, acute treatment-related toxicities should have resolved and any treated lesions are not the sole sites used to determine progressive disease.
  • Prior exposure to androgen receptor pathway inhibitors (ARPIs) must meet one of the following criteria:
  • For traditional nonsteroidal antiandrogens (e.g., bicalutamide, nilutamide, flutamide): Participants should have discontinued such antiandrogen for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to screening. In addition, participants who demonstrate an antiandrogen withdrawal response, defined as a >25% decline in PSA within 4-6 weeks after stopping the nonsteroidal antiandrogen, are not eligible until the PSA rises above the nadir observed after withdrawal.
  • For other ARPIs (e.g., enzalutamide, abiraterone, apalutamide, darolutamide): Participants must meet one of the following conditions:
  • No prior treatment with any of such ARPIs; or
  • Prior treatment with only one such ARPI and experienced only one documented disease progression while on that therapy, and the investigator assesses that the participant is suitable for switching to a different ARPI of this class; or
  • Currently receiving the first such ARPI (e.g., enzalutamide, abiraterone, apalutamide, darolutamide) and has radiographically stable disease but isolated PSA progression per PCWG4 criteria; or
  • Prior treatment with one such ARPI with documented disease progression, where the investigator determines that continuation of the same ARPI or switching to another ARPI is not expected to provide meaningful clinical benefit. Such participants may be eligible while continuing standard ADT without an ARPI, provided that no immediate alternative systemic anticancer therapy is clinically required.
  • For participants currently or previously treated with abiraterone, the concomitant corticosteroid (e.g., prednisone) used with abiraterone should also meet the requirements of Exclusion Criterion #3.
  • Life expectancy of at least 12 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and independent in activities of daily living (ADL).
  • Adequate hematologic, renal and liver function as evidenced at screening.
  • Hemoglobin ≥9.0 g/dL
  • Absolute neutrophil count ≥1.0×109/L
  • Platelet count ≥100×109/L
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (or ≤3.0×ULN for participants with tumor involvement in the liver)
  • Serum albumin ≥3.0 g/dL
  • Serum total bilirubin ≤1.5×ULN; participants with congenital bilirubinemia, such as Gilbert's syndrome, may enroll if conjugated bilirubin is ≤1.5×ULN
  • In the absence of anticoagulant therapy, prothrombin time (PT) or international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN
  • Creatinine < 175 µmol/L
  • No known history of human immunodeficiency virus infection (HIV) 1 and 2, human T-lymphotropic virus type 1 (HTLV-1), syphilis, active Hepatitis B or Hepatitis C.
  • If participant is sexually active, he must observe contraceptive/barrier requirements with:
  • documented bilateral orchiectomy, or
  • agreement to practice abstinence from penile-vaginal intercourse or use condoms/barrier protection from Screening until 12 months after the last dose of KMV002, and
  • agreement to refrain from sperm donation from Screening until 12 months after the last dose of KMV002, and
  • highly effective contraceptive methods applied to WOCBP who are sexual partners of male participants for the specified duration, in addition to male condom use, from Screening until 12 months after the last dose of KMV002.
  • Willing to comply with the study requirements and to provide written informed consent prior to the initiation of study procedures.

Who cannot join

  • The presence of known brain metastasis or leptomeningeal disease, malignant pleural effusions, or malignant ascites.
  • Toxicity related to prior anticancer therapy has not returned to Grade ≤1 or baseline levels (except for alopecia, vitiligo, Grade 2 peripheral neuropathy, radiation tissue fibrosis, radiation cystitis, and radiation proctitis).
  • Treatment with any of the following medications within 28 days before screening, or while on study, is prohibited:
  • Systemic corticosteroids > prednisolone 10 mg or equivalent.
  • Physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (e.g., in participants with exacerbations of reactive airway disease or to prevent intravenous (IV) contrast allergic reaction or anaphylaxis in participants who have known contrast allergies) are permitted.
  • Other investigational or approved therapies for mAPMR (excluding denosumab and bisphosphonates).
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  • Received or plans to receive PAP-directed therapy at any time before screening, or while on study.
  • Received or plans to receive any live or live-attenuated vaccine within 4 weeks before the first dose of study drug or while on study. Inactivated or non-live vaccines (e.g., authorized or approved vaccines such as COVID-19, influenza, rabies, tetanus toxoid) are allowed if not administrated within 72 hours before or after KMV002 dosing.
  • Prior or anticipated radiation therapy, including: radiation for primary tumor within 4 weeks prior to screening, radiation or radionuclide therapy for metastasis within 4 weeks prior to screening (excluding palliative radiation for pain control), or anticipated need for such therapy (e.g., for imminent pathological fracture or spinal cord compression) while on study.
  • Unstable symptomatic ischemic heart disease, ongoing arrhythmias or New York Heart Association (NYHA) Class III or IV heart failure.
  • Prior cytotoxic chemotherapy within 3 months before screening is prohibited (for example, but not limited to, docetaxel, mitoxantrone, cabazitaxel). Received more than one chemotherapy regimens at any time before screening.
  • Treatment with any investigational vaccine within 2 years before screening or treatment with any other investigational product within 4 weeks before screening.
  • Had major surgery (e.g., requiring general anesthesia) within 4 weeks before screening or has not recovered from surgery. Must not have major surgery planned during the time the participant is receiving the study drug. Participants with recent or planned surgical procedures utilizing only local anesthesia may participate.
  • Malignancy diagnosis other than the disease under study within 2 years prior to the first dose of KMV002, except for squamous and basal cell carcinoma of the skin, non-muscle invasive bladder cancer, cervical intraepithelial neoplasia or any malignancy considered cured or has minimal risk of recurrence within 1 year of first dose of KMV002 (in the opinion of both the investigator and medical monitor).
  • Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.
  • Paget's disease of bone.
  • Active autoimmune diseases or history of autoimmune disease requiring systemic immunosuppressive therapy (including but not limited to corticosteroids >10 mg/day prednisone equivalent, methotrexate, azathioprine, anti-TNF agents, tocilizumab). Exceptions (allowed without systemic therapy): vitiligo, diabetes mellitus, and Hashimoto's thyroiditis on appropriate replacement therapy may be enrolled. Other autoimmune conditions that are clinically stable and do not require systemic immunosuppression may be considered on a case-by-case basis after discussion with the Sponsor.
  • History of significant local or systemic reactogenicity to any prior vaccine or to CpG ODN (e.g., anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration).
  • Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chief Scientific Officer, PhD contact

+1-917-439-9820

contact@chimigen.com

Australia2 sites

  • Epworth Foundation trading as Epworth HealthCare

    East Melbourne, Victoria, 3002

    Arun Azad, Prof, +03-9483-6033, arun.azad@petermac.org

  • Macquarie University

    North Ryde, New South Wales, 2109

    Carole Harris, Dr, +02-9812-2956, carole.harris@mqhealth.org.au

Other trials in Australia

About this study

Official title: A Phase I, Open-label, Dose-escalation and Dose-expansion Study of KMV002 in Patients With Metastatic Androgen Pathway Modulation-Resistant (mAPMR) Prostate Cancer

This is a first-in-human (FIH) open-label, multicenter, dose-escalation and dose-expansion Phase I study of KMV002 in metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer patients. This study consists of two parts: dose escalation (Part 1) and dose expansion (Part 2). Following a screening period, eligible mAPMR patients will be enrolled to receive their assigned regimen of KMV002 (a combination of SN3001C and CpG ODN adjuvant). KMV002 will be given as either a 5-dose or 6-dose regimen.

Being tested
KMV002
Keywords
KMV002, SN3001C, mCRPC, mAPMR, androgen pathway modulation-resistant prostate cancer, castration-resistant prostate cancer

What participants receive

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

  • KMV002Biological

    50 μg SN3001C + 3.0 mg CpG ODN, 5-dose regimen, for subcutaneous (SC) injection

  • KMV002Biological

    150 μg SN3001C + 3.0 mg CpG ODN, 5-dose regimen, for subcutaneous (SC) injection

  • KMV002Biological

    150 μg SN3001C + 3.0 mg CpG ODN, 6-dose regimen, for subcutaneous (SC) injection

  • KMV002Biological

    450 μg SN3001C + 3.0 mg CpG ODN, 5-dose or 6-dose regimen, for subcutaneous (SC) injection

Study groups in NCT07866300
Study groupRoleWhat they receive
Cohort 1: 50 μg (5-dose regimen)ExperimentalNot described
Receives: Biological: KMV002
Cohort 2a: 150 μg (5-dose regimen)ExperimentalNot described
Receives: Biological: KMV002
Cohort 2b: 150 μg (6-dose regimen)ExperimentalNot described
Receives: Biological: KMV002
Cohort 3: 450 μg (5-dose or 6-dose regimen, TBD)ExperimentalNot described
Receives: Biological: KMV002

What is being measured

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

  1. Incidence and severity of AEs, including dose limiting toxicity (DLT).

    Number of participants with AEs assessed by CTCAE 6.0. AEs include treatment-emergent adverse events (TEAEs), important adverse events, serious adverse events (SAEs), adverse events of special interest (AESIs).

    Measured: From first dose through 28 days after the last dose

Secondary outcomes (6)

  1. Serum PAP-specific antibody titers

    Serum anti-PAP antibody titers measured by enzyme linked immunosorbent assay (ELISA), Geometric mean titers (GMTs), and 95% confidence intervals (95% CI) will be calculated per cohort.

    Measured: From before the first dose through 28 days after the 5 dose (5-dose regimen) or 6 dose (6-dose regimen)

  2. Seroconversion (anti-PAP antibody)

    Serum anti-PAP antibody titers will be measured by ELISA. Seroconversion is defined as the appearance of antibodies [i.e., concentrations/titer greater than or equal to the lower limit of quantification (LLOQ)] in the serum of participants seronegative before investigational product administration.

    Measured: From before the first dose through 28 days after the 5 dose (5-dose regimen) or 6 dose (6-dose regimen)

  3. Objective response rate

    The proportion of participants who have a complete response (CR) or partial response (PR) according to the RECIST V1.1 criteria without evidence of bone progression according to PCWG4. Response to treatment will be evaluated by the investigator.

    Measured: From first dose through 28 days after the last dose

  4. Radiological Progression-free Survival (rPFS)

    The time from the first investigational product administration to first objective evidence of radiographic disease progression assessed by the Investigator, or death, whichever occurs first. The evidence of disease progression is defined by:

    Progression of soft tissue lesions measured by CT or MRI as defined in RECIST 1.1.

    Progression by bone lesions observed by bone scan and based on PCWG4.

    Measured: From first dose through 28 days after the last dose

  5. PSA50 response rate and PSA90 response rate

    The proportion of participants with a reduction in the PSA level of ≥50% or ≥90% from baseline to the lowest post-baseline PSA results, measured twice, at least 3 weeks apart by the PCWG4 criteria.

    Measured: From first dose through 28 days after the last dose

  6. Time to First Subsequent Therapy (TFST)

    TFST is defined as the time from the date of the first investigational product administration to the date of initiation of the first subsequent therapy. Subsequent therapy refers to systemic antitumor treatment initiated after the participant has discontinued the study treatment and during the follow-up period. In addition to radiographic progression, TFST also includes other reasons for changing therapy (e.g., due to drug toxicity or clinical progression).

    Measured: From first dose through 28 days after the last dose

Timeline

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

  1. First posted8 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionSep 2030 (estimated)
  4. Study completionSep 2030 (estimated)

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07866300
Sponsor's protocol ID
CMG.KMV002-101
Status last verified
Oct 2026
First submitted
23 Sep 2026
Last updated
8 Oct 2026
Results posted
No
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 KMV002 in people with Prostate Cancer Metastatic Castration-Resistant, run by Chimivac INC at 2 sites in Australia.

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 39 inclusion and 19 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Chief Scientific Officer, PhD (+1-917-439-9820, contact@chimigen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of AEs, including dose limiting toxicity (DLT). (time frame: From first dose through 28 days after the last dose). 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 NCT07866300.

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 8 Oct 2026.

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