PQ203 for advanced solid tumors including triple negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, first-in-human Phase 1 trial gives PQ203 as a once-weekly IV infusion to adults with selected advanced solid tumors, including TNBC. Phase 1A uses dose escalation with an expansion cohort to establish a provisional recommended Phase 2 dose, while Phase 1B refines the dose and further characterizes safety and pharmacokinetics. Primary endpoints are treatment-emergent adverse events and determination of the RP2D, and secondary endpoints include PK of PQ203 and its MMAE payload plus preliminary antitumor activity. Eligible patients must have measurable disease, ECOG 0-1, and adequate organ function to enroll.

Why it matters

Who can join: the full rules

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

Where it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• NEXT Oncology
  San Antonio, Texas, United States Recruiting
• START Mountain Region
  West Valley City, Utah, United States Recruiting
• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.