A Study of KMV002 in Patients With mAPMR Prostate Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-80
SponsorChimivac INC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
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.
Trial design
Design model
Sequential
Treatments tested in this trial
KMV002
Biological/Vaccine50 μg SN3001C + 3.0 mg CpG ODN, 5-dose regimen, for subcutaneous (SC) injection
KMV002
Biological/Vaccine150 μg SN3001C + 3.0 mg CpG ODN, 5-dose regimen, for subcutaneous (SC) injection
KMV002
Biological/Vaccine150 μg SN3001C + 3.0 mg CpG ODN, 6-dose regimen, for subcutaneous (SC) injection
KMV002
Biological/Vaccine450 μg SN3001C + 3.0 mg CpG ODN, 5-dose or 6-dose regimen, for subcutaneous (SC) injection
Treatment groups
24 Participants
are divided into 4 treatment groupsGroup A: Cohort 1: 50 μg (5-dose regimen)Experimental treatment 1 intervention
Group B: Cohort 2a: 150 μg (5-dose regimen)Experimental treatment 1 intervention
Group C: Cohort 2b: 150 μg (6-dose regimen)Experimental treatment 1 intervention
Group D: Cohort 3: 450 μg (5-dose or 6-dose regimen, TBD)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
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).
Time frame
From first dose through 28 days after the last doseSecondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
From first dose through 28 days after the last dose4
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.
Time frame
From first dose through 28 days after the last doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chimivac INC
Lead sponsor
Chimigen Biomedical (Chengdu) Co., Ltd.
Collaborator
Source ClinicalTrials.gov
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