No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
ProteinQure Inc. · Industry
Who this trial is looking for
This trial is looking for adults with advanced solid tumors, including triple negative breast cancer. Participants will receive a treatment called PQ203 to test its safety and how well it works.
Are You a Good Fit for This Trial?
Rules you outSevere heart diseaseActive interstitial lung disease
You may be able to join if
I am at least 18 years old.
I have been diagnosed with advanced solid tumors that have not responded to standard treatments.
I have measurable disease as confirmed by tests.
I have good performance status with less impact on daily activities.
My organ functions meet the required criteria.
I understand the study and can sign the consent form.
I agree to use effective contraception if I can become pregnant.
The side effects from previous treatments have improved.
You may not be able to join if
I have a primary brain cancer.
I have received a blood transfusion in the last 14 days.
I have serious medical conditions that could affect treatment.
I have a history of severe heart disease.
My QTc interval is longer than 470 ms.
I weigh more than 115 kg (253 lbs).
I am pregnant or breastfeeding.
I have had a stroke in the last 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* 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) perform…
Inclusion Criteria:
* 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
* Adequate organ function confirmed by the following laboratory values obtained within 14 days of the first dose of PQ203:
Bone Marrow Function
* Absolute neutrophil count (ANC) ≥ 1.5 × 10e9/L
* Platelets \> 100 × 10e9/L
* Hemoglobin ≥ 9 g/dL
Hepatic Function
* AST, alanine transaminase ALT or ALP ≤ 2.5 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
* Bilirubin ≤ 1.5 × ULN (\< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome)
* Serum albumin ≥ 35 g/L (3.5 g/dL)
Renal Function
* Calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault equation
* Urine protein \< 2+
Cardiac Function
• Left ventricular ejection fraction (LVEF) ≥ 50%
Other
* Understand and voluntarily sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Research Ethics Board (REB)-approved informed consent form prior to any study-specific evaluation.
* PT/PTT or INR \<1.2x upper limit of normal
* Non-surgically sterile men and women of child bearing potential must agree to use highly effective methods of contraception for at least 4 months beyond the final dose received.
* Toxicity of previous antitumor therapy has returned to Grade ≤1
Exclusion Criteria:
* 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
* QTc interval using Fridericia's formula (QTcF) \> 470 ms
* Estimated or known weight \> 115 kg (253 lbs)
* Known/suspected pregnancy and/or lactation
* Diastolic blood pressure \< 60 mmHg or \>110 mmHg
* Uncontrolled intercurrent illness
* Long term care facility resident or prisoner
* Any prior receipt of a MMAE-containing drug
* Any prior receipt of a SORT1-targeting medication
* Participation in another clinical study investigating a drug or medical device or a neuro-interventional or surgical procedure that is not considered as standard care in the 30 days preceding study enrolment
* Treatment with any of the following:
* Chemotherapy or other systemic anti-cancer therapy ≤14 days or 5 half-lives (whichever is shorter) prior to first dose of study drug except for Nitrosoureas or mitomycins ≤42 days
* Major surgery ≤28 days from first dose of study drug
* Patients with a history of cerebrovascular accident within 6 months of planned first dose.
* Patients with clinically symptomatic ocular toxicities
* Patients with history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that require steroids, with current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
* Patients with active Grade \>1 peripheral neuropathy
Contacts
No contact information available.
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