Open-label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer

P

Propella Therapeutics

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

mCSPC
mCRPC
Prostate Cancer

Treatments

Drug: prednisone
Drug: dexamethasone
Drug: PRL-02 injection
Drug: docetaxel infusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT04729114
PRL-02-1001

Details and patient eligibility

About

A Phase 1/2a, open-label, multicenter study of intramuscular (i.m.) PRL-02 depot in participants with advanced prostate cancer.

Full description

Phase 1/2a, open-label, multicenter study of intramuscular (i.m.) PRL-02 depot in participants with castration-sensitive prostate cancer (CSPC) and metastatic castration-resistant prostate cancer (mCRPC). In Phase 1 (Dose Escalation), participants will receive escalating doses of i.m. PRL-02 in 84-day treatment cycles combined with daily oral steroid. In Phase 2a (Dose Expansion), participants with metastatic castration-sensitive prostate cancer (mCSPC) and mCRPC will receive i.m. PRL-02 at one or more recommended Phase 2 doses (RP2Ds) selected from Phase 1 in 84-day treatment cycles in combination with dexamethasone and docetaxel (Group F1) or in combination with dexamethasone (Groups F2, G). In both phases, participants will undergo scheduled periodic assessments of prostate specific antigen (PSA), testosterone and progesterone levels in the blood.

Enrollment

100 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histological evidence of adenocarcinoma of the prostate, including metastatic castration sensitive prostate cancer (mCSPC); castration sensitive prostate cancer (CSPC); castration sensitive prostate cancer (CSPC); metastatic castration resistant prostate cancer (mCRPC)
  • Undergone bilateral orchiectomy or ongoing GnRH agonist or antagonist therapy for at least 6 weeks prior to the first dose of study drug which must be continued throughout the study
  • Eastern Cooperative Oncology Group (ECOG) of 0 or 1
  • For Phase1 expansion Groups D & E only, received prior darolutamide, apalutamide, abiraterone or enzalutamide and have documented evidence of progression

Exclusion criteria

  • Known active central nervous system (CNS) metastases, except those who have been treated with surgery and/or radiation therapy, who are off pharmacologic doses of glucocorticoids, and who are neurologically stable.
  • Known additional malignancy beyond prostate cancer that required active treatment with the exception of: adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type; adequately treated Stage I cancer from which the patient is currently in remission and has been in remission for ≥2 years; any other cancer from which the patient has been disease-free for ≥5 years
  • Clinically significant cardiac disease
  • Received chemotherapy within 2 weeks or 5 half-lives of first dose of study drug
  • Current treatment with enzalutamide, flutamide, nilutamide, bicalutamide, or any other androgen receptor (AR) blocking agents. Patients who have received anti-androgens or AR blocking agents must have discontinued bicalutamide ≥6 weeks and other antiandrogens ≥4 weeks prior to the first dose of PRL-02.
  • Prior treatment with estrogens within 12 weeks of the first dose of study drug
  • Need for systemic glucocorticoids greater than replacement doses; the use of topical, intraocular, inhalational, intranasal, or intra-articular glucocorticoids is permitted.
  • Required concomitant use of strong inducers of CYP3A4.
  • Known hypersensitivity to PRL-02, abiraterone, abiraterone decanoate, prednisone, or dexamethasone or any of their excipients or components.
  • Hemoglobin A1c (HbA1c) >10% in patients previously diagnosed with diabetes mellitus. HbA1c >8% in patients whose diabetes mellitus is previously undiagnosed. (Excluded patients may be rescreened after referral and evidence of improved control of their condition).
  • Body mass index > 40 kg/m^2

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

100 participants in 10 patient groups

Cohort 1
Experimental group
Description:
180 mg PRL-02 + dexamethasone or prednisone
Treatment:
Drug: PRL-02 injection
Drug: dexamethasone
Drug: prednisone
Cohort 2
Experimental group
Description:
360 mg PRL-02 + dexamethasone or prednisone
Treatment:
Drug: PRL-02 injection
Drug: dexamethasone
Drug: prednisone
Cohort 3
Experimental group
Description:
720 mg PRL-02 + dexamethasone or prednisone
Treatment:
Drug: PRL-02 injection
Drug: dexamethasone
Drug: prednisone
Cohort 4
Experimental group
Description:
1260 mg PRL-02 + dexamethasone or prednisone
Treatment:
Drug: PRL-02 injection
Drug: dexamethasone
Drug: prednisone
Cohort 5
Experimental group
Description:
1800 mg PRL-02 + dexamethasone or prednisone
Treatment:
Drug: PRL-02 injection
Drug: dexamethasone
Drug: prednisone
Phase 1 Expansion Group D
Experimental group
Description:
Prior abiraterone
Treatment:
Drug: PRL-02 injection
Drug: dexamethasone
Phase 1 Expansion Group E
Experimental group
Description:
Prior enzalutamide, apalutamide and/or darolutamide
Treatment:
Drug: PRL-02 injection
Drug: dexamethasone
Phase 2a Dose Expansion Group F1
Experimental group
Description:
Dosing at recommended Phase 2 dose (RP2D); high volume mCSPC
Treatment:
Drug: docetaxel infusion
Drug: PRL-02 injection
Drug: dexamethasone
Phase 2a Dose Expansion Group F2
Experimental group
Description:
Dosing at RP2D; low volume mCSPC
Treatment:
Drug: PRL-02 injection
Drug: dexamethasone
Phase 2a Dose Expansion Group G
Experimental group
Description:
Dosing at RP2D; mCRPC
Treatment:
Drug: PRL-02 injection
Drug: dexamethasone

Trial contacts and locations

14

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Central trial contact

Katie McDougall

Data sourced from clinicaltrials.gov

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