Actively Recruiting
A Phase 1, Open-label, Multicenter Trial Evaluating Safety, Pharmacokinetics, and Anti-Cancer Activity of PQ203 in Advanced Solid Tumors
Led by ProteinQure Inc. · Updated on 2026-02-23
80
Participants Needed
4
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating PQ203, a peptide drug-conjugate, in patients with advanced solid tumors including triple negative breast cancer (TNBC). This open-label, first-in-human study aims to determine the safety and tolerability of PQ203, establish a recommended Phase 2 dose, and assess its pharmacokinetics and preliminary antitumor activity. The study includes patients whose cancer has progressed despite standard treatments or who cannot receive approved therapies. PQ203 is given as a once-weekly intravenous infusion. The study has two parts: Phase 1A includes dose escalation and expansion to find the recommended dose and evaluate safety in selected tumor types. Phase 1B further assesses this dose to better understand safety, drug levels in the body, and early signs of effectiveness. All participants receive PQ203, and the study plans up to seven ascending dose groups. Participants will be closely monitored from the time of informed consent until about 28 days after the last dose. Assessments include tracking treatment-related side effects, measuring tumor response, and evaluating how the drug moves and acts in the body. Laboratory tests will assess organ function before dosing. Safety, tolerability, and preliminary antitumor effects are the main outcomes. The study may continue up to early 2029.
CONDITIONS
Brief 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
- Histologically or cytologically confirmed metastatic or locally advanced solid tumor malignancies progressed after or ineligible for standard therapies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Measurable disease documented by RECIST v1.1
- Adequate bone marrow function: ANC 3 1.5 x 10e9/L, platelets > 100 x 10e9/L, hemoglobin 3 9 g/dL
- Adequate hepatic function: AST, ALT, ALP 2.5 x ULN (up to 5 x ULN with liver metastases), bilirubin 1.5 x ULN (up to 2 x ULN for Gilbert's syndrome), serum albumin 3 35 g/L
- Adequate renal function: creatinine clearance 3 60 mL/min, urine protein < 2+
- Left ventricular ejection fraction (LVEF) 3 50%
- PT/PTT or INR < 1.2 x ULN
- Ability to understand and sign informed consent
- Non-surgically sterile men and women of childbearing potential agree to use effective contraception for at least 4 months after last dose
- Toxicity from prior antitumor therapy returned to Grade 1
You will not qualify if you...
- Primary central nervous system malignancies (stable brain metastases 4 weeks after treatment allowed if no steroids or other treatment needed)
- Blood transfusion within 14 days before study treatment
- Serious comorbid medical conditions interfering with study treatment
- History of severe heart disease
- QTcF interval > 470 ms
- Weight > 115 kg (253 lbs)
- Known or suspected pregnancy or lactation
- Diastolic blood pressure < 60 mmHg or > 110 mmHg
- Uncontrolled intercurrent illness
- Residence in long-term care facility or prisoner status
- Prior treatment with MMAE-containing drugs or SORT1-targeting medications
- Participation in another clinical study with investigational drug/device within 30 days before enrollment
- Chemotherapy or systemic anti-cancer therapy within 14 days or 5 half-lives before first dose (except certain drugs within 42 days)
- Major surgery within 28 days before first dose
- History of cerebrovascular accident within 6 months
- Clinically symptomatic ocular toxicities
- History or current interstitial lung disease/pneumonitis requiring steroids or suspected but unruled out ILD/pneumonitis
- Active Grade >1 peripheral neuropathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated weekly infusions until disease progression or discontinuation
Participants receive PQ203 as a once-weekly intravenous infusion to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity.
Weekly visits for infusions
Duration - About 28 days
Participants are monitored for safety and treatment-emergent adverse events for approximately 28 days after the last dose of PQ203.
1 to 2 follow-up visits
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here