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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
PQ203
DrugPQ203 is a peptide drug-conjugate given once weekly by intravenous infusion intended for the treatment of advanced solid tumor cancers including triple negative breast cancer.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: PQ203Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment-emergent Adverse Events
The incidence and severity of Adverse Events (AEs) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) to assess safety and tolerability.
Time frame
From the time of informed consent until ~28 days after the last dose of PQ2032
Objective Response Rate (ORR)
Tumor growth will be assessed using standard imaging techniques and scored by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). An Objective response rate (ORR), defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) will be calculated to assess preliminary signals of anti-tumor activity.
Time frame
From informed consent until ~28 days after the last dose of PQ203Secondary outcomes
1
Progression free survival
Progression free survival (PFS; time from first dose to date of documentation of disease progression) in months will be determined.
Time frame
From informed consent to ~28 days after the last dose of PQ2032
Pharmacokinetics: Determine the Cmax of PQ203
Plasma concentration-time profiles will be used to identify the maximum drug concentration in plasma (ng PQ203/mL)
Time frame
From first day of dosing to ~28 days after the last day of dosing3
Pharmacokinetics: half-life of PQ203 in plasma
Plasma concentration-time profiles will be used to determine the half life (in hours) of PQ203 in plasma
Time frame
From first day of dosing until ~28 days after the last dose4
Pharmacokinetics: PQ203 exposure
Plasma concentration-time profiles will be used to determine the area under the curve (AUC) in ng/mL x hours
Time frame
from first dose through ~28 days after the last doseSponsors and contacts
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Source ClinicalTrials.gov