Идёт набор NCT07190469

PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer

Фаза I С лечением Triple Negative Breast Cancer (TNBC) Advanced Solid Tumors Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: PQ203.
Кому может быть актуально: Состояния в реестре: Triple Negative Breast Cancer (TNBC), Advanced Solid Tumors Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1, Open-label, Multicenter Clinical Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Anti-Cancer Activity of PQ203 in Patients With Advanced Solid Tumor Malignancies

Обзор

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.

Подробное описание

This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PQ203 in patients with selected advanced solid tumors. PQ203 will be administered as a once-weekly intravenous infusion.

The study consists of two parts: Phase 1A (dose escalation/expansion) and Phase 1B (dose optimization).

* Phase 1A will employ a dose-escalation design in patients with advanced solid tumors to assess the safety and tolerability of PQ203 as monotherapy and to establish a provisional Recommended Phase 2 Dose (RP2D). A dose-expansion component will further evaluate the provisional RP2D in one or more selected tumor types. * Phase 1B will assess the provisional RP2D and further characterize safety, pharmacokinetics, and preliminary efficacy.

Endpoints:

* Primary Endpoints: Incidence of treatment-emergent adverse events (TEAEs) and determination of the RP2D. * Secondary Endpoints: Pharmacokinetic profile of PQ203 and its payload (MMAE), and preliminary evidence of antitumor activity.

Вмешательства

Препарат PQ203
PQ203 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.

Первичные конечные точки

Incidence of treatment-emergent Adverse Events [Срок оценки: From the time of informed consent until ~28 days after the last dose of PQ203]
Objective Response Rate (ORR) [Срок оценки: From informed consent until ~28 days after the last dose of PQ203]

Вторичные конечные точки (5)

Progression free survival [Срок оценки: From informed consent to ~28 days after the last dose of PQ203]
Pharmacokinetics: Determine the Cmax of PQ203 [Срок оценки: From first day of dosing to ~28 days after the last day of dosing]
Pharmacokinetics: half-life of PQ203 in plasma [Срок оценки: From first day of dosing until ~28 days after the last dose]
Pharmacokinetics: PQ203 exposure [Срок оценки: from first dose through ~28 days after the last dose]
Duration of Objective Response [Срок оценки: From Informed consent to ~28 days after the final dose]

Критерии участия

Критерии включения

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

Критерии исключения

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