Actively Recruiting
PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer
Led by ProteinQure Inc. · Updated on 2026-02-23
80
Participants Needed
4
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Diagnosed with metastatic or locally advanced solid tumor malignancies that have progressed or are not eligible for standard treatments
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Measurable disease as per RECIST v1.1 criteria
- Adequate bone marrow, liver, kidney, and heart function as confirmed by lab tests within 14 days before first PQ203 dose
- Able to understand and voluntarily sign informed consent
- Non-surgically sterile men and women of childbearing potential must agree to use highly effective contraception for at least 4 months after last dose
- Previous antitumor therapy toxicities have returned to Grade 1 or less
You will not qualify if you...
- Primary central nervous system (CNS) malignancies (except stable brain metastases not requiring treatment)
- Blood transfusion within 14 days before treatment
- Serious comorbid medical conditions interfering with treatment
- History of severe heart disease
- QTc interval by Fridericia's formula > 470 ms
- Weight over 115 kg (253 lbs)
- Known or suspected pregnancy or breastfeeding
- Diastolic blood pressure below 60 mmHg or above 110 mmHg
- Uncontrolled illnesses
- Residents of long-term care facilities or prisoners
- Prior treatment with MMAE-containing drugs or SORT1-targeting medications
- Participation in another clinical study within 30 days before enrollment
- Chemotherapy or systemic anti-cancer therapy within 14 days (except specific drugs with longer limits)
- Major surgery within 28 days before first dose
- History of stroke within 6 months before first dose
- Clinically symptomatic eye toxicities
- History or current interstitial lung disease/pneumonitis requiring steroids or suspected but not ruled out by imaging
- Active peripheral neuropathy greater than Grade 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
2
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
3
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
4
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 0C6
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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