Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Trial acronym
FPI-2265-203
Clinical summary
Summary
This study will be conducted in two parts, and each part will be evaluating two treatment regimens.
The part of the study you are assigned to is based on whether or not you have previously had treatment with lutetium-177 (177Lu) vipivotide tetraxetan or other 177Lu-PSMA radioligand therapy (RLT). Those who have had prior treatment with these agents will enrol in Part A, and those who have not will enrol in Part B.
For each part of the study, a Simon 2-stage design will be used to evaluate two dosing regimens. Participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) will be allocated to Arm 1 and Arm 2 in a singular, alternating fashion, until all Stage 1 participants are enrolled into each of the two regimens:
- Arm 1: Will consist of up to 6 doses of FPI-2265 every 6 weeks at Dose A and Olaparib twice a day on Days 1 and 14 of each cycle.
- Arm 2: Will consist of up to 9 doses of FPI-2265 every 4 weeks at Dose B and Olaparib twice a day on Days 1 and 14 of each cycle.
Participants will be monitored and assessed for efficacy response, disease progression and adverse events.
Conditions
This trial is treating people with metastatic castration-resistant prostate cancer
Eligibility
Inclusion
- Adult male participants with mCRPC that is progressing at the time of study entry
- ECOG performance status 0-1 and life expectancy of at least three months
- Must have received at least one novel anti-androgen deprivation therapy
- Participants with known BRCA mutations should have received approved therapies such as PARP inhibitors, per Investigator discretion.
- All prior treatment-related AEs must have resolved to CTCAE Grade ≤1 (except alopecia).
- Participants must have had prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L)
- Positive PSMA PET/CT scans .
-
Participants must have adequate organ and bone marrow function:
- Hgb >/= 9g/dL
- Platelets >/= 100 x 10^9/L
- ANC </= 1.5 x 10^9/L
- CrCL >/= 50 mL/min
Exclusion
- Previous treatment with any of the following within 6 months of first dose: Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation.
- Participants who received more than two (2) prior lines of cytotoxic chemotherapy for CRPC.
- Participants with known unresolved urinary tract obstruction.
- Transfusion- or growth factor-dependent participants.
- Participants with a history of CNS metastases are excluded, except those who have received therapy (and are neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity.
- Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
- Participants with any liver metastases.
- Participants with skeletal metastases presenting as a superscan .
- Previous history of interstitial lung disease or non-infectious pneumonitis.
- Participants with a history or clinical and/or laboratory features suggestive of MDS/AML.
- Major surgery ≤28 days prior to the first dose of study treatment.
- Planning to conceive a pregnancy during the treatment and up to six months after the last treatment.
- Participants unable to swallow orally administered medications or with malabsorptive gastrointestinal disorders.
- Concomitant use of known strong or moderate CYP3A inhibitors or inducers
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Fusion Pharmaceuticals Inc.
Scientific Title
A Phase 2, Open-label, Multi-centre Study of FPI-2265 (225Ac-PSMA-I&T) and Olaparib in Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information