PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorProteinQure Inc.
About this trial
The primary purposes of this study are to determine the safety and tolerability of PQ203 in patients with advanced solid tumors including triple negative breast cancer (TNBC), and to determine a recommended Phase 2 dose level for future studies in TNBC.
Eligibility criteria
Qualifiers
At least 18 years old
Histologically or cytologically documented metastatic or locally advanced solid tumor malignancies having progressed through or being otherwise ineligible to receive approved standard-of-care therapies
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Documented presence of RECIST v1.1 measurable disease
Disqualifiers
Patients with primary central nervous system (CNS) malignancies (Patients with stable brain metastases (≥ 4 weeks after a treatment) not requiring steroids or other treatment will be allowed on study).
Blood transfusion within 14 days of study treatment
Serious comorbid medical conditions such as heart, lung, kidney, liver, and brain disease that, in the opinion of the enrolling investigator, could interfere with study treatment
Subjects with history of severe heart disease
Trial design
Treatments tested in this trial
- PQ203
Treatment groups
80 Participants
are divided into 1 treatment groupLocations
4Canada
Princess Margaret Cancer CentreM5G 0C6, TorontoOntario, Canada
United States
MD Anderson Cancer Center77030, HoustonTexas, United States
NEXT Oncology78229, San AntonioTexas, United States
START Mountain Region84119, West Valley CityUtah, United States
Sponsors and collaborators
ProteinQure Inc.
Lead sponsor
Source ClinicalTrials.gov