intravenous infusion once weekly for 2 consecutive weeks of a 4-week cycle

PLX038

This is a Phase I, open-label, two-arm, dose escalation study of PLX038 intravenous infusion administered to patients with refractory or relapsed solid tumors. This study will explore two different dosing schedules: Arm 1, once every 3 week (q3w), and Arm 2, once weekly for 2 consecutive weeks of a 4-week cycle.

PLX038 is an investigational drug product that has demonstrated reasonable antitumor activity in preclinical colorectal, gastric and lung tumor models in animals. This is a first in human trial to determine the maximum, safest dose of PLX038 IV that can be administered to patients either once every 3 weeks or once every 2 weeks.

A Phase I Study of PLX038 in Patients With Advanced Solid Tumors

Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.03). Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

ProLynx LLC

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Patients will be treated at a dose of 1730mg/m2 IV infusion on Day 1 of each cycle Q3W (every 21 days, 1 cycle = 1 injection) after at least a first cycle at 1300mg/m2. At the discretion of the treating physician, the PLX038 dose will be increased to 1730 mg/m2 for patients who tolerate at least 1 cycle without any of the following toxicities: febrile neutropenia, grade 4 neutropenia for \> 5 days or ANC \< 100 109/L for more than 1 day, or other non-hematological toxicities of Grade \> 2 \[NCI-CTCAE, Version 5\].

Study treatment will be at a dose of 1730mg/m2 IV infusion on Day 1 of each cycle Q3W (every 21 days, 1 cycle = 1 injection) after at least a first cycle at 1300mg/m2.

Patients with a clinical benefit could be treated as long as study is ongoing. Patients are followed from inclusion until documented disease progression, withdrawal of consent, or death.

Fouzia Azzouz

François-Clément Bidard, Study Principal Investigator

François-Clément Bidard

Single arm phase II study for with primary objective to evaluate the efficacy of PLX038 on response rate for patients with pretreated, metastatic or locally advanced triple negative breast cancer.

This is an open label, multi-centric phase II study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of PLX038 in locally-advanced or metastatic TNBC. Patient must have received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, taxane and sacituzumab-govitecan (unless not medically appropriate or contraindicated for the patient) and Received a minimum of two prior cytotoxic chemotherapy regimens for locally advanced or metastatic breast cancer.

Patients will be treated at a dose of 1730mg/m2 IV infusion on Day 1 of each cycle Q3W (every 21 days, 1 cycle = 1 injection) after at least a first cycle at 1300mg/m2. At the discretion of the treating physician, the PLX038 dose will be increased to 1730 mg/m2 for patients who tolerate at least 1 cycle without any of the following toxicities: febrile neutropenia, grade 4 neutropenia for \> 5 days or ANC \< 100 109/L for more than 1 day, or other non-hematological toxicities of Grade \> 2 \[NCI-CTCAE, Version 5\].

All included patients will receive PLX038 as single agent as long as study is ongoing or until progression of disease, unacceptable toxicity, patient withdrawal of consent, Investigator decision, lost to follow-up, death, patient non-compliance, or study termination by Sponsor.

Tumor assessments must be performed according to the RECIST V1.1 criteria at inclusion and every 8 weeks (± 7 days) from inclusion until documented disease progression, withdrawal of consent, or death. Radiographic measurements must be performed to the RECIST specifications.

A Study to Evaluate the Efficacy and Toxicities of PLX038, in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer

A Phase II Study to Evaluate the Efficacy and Toxicities of PLX038, in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Best tumor response (defined as PR or CR in the first 6 months of treatment, assessed by investigators per RECIST v1.1 criteria).

Time to response is defined as the time from inclusion to the first objective tumor response and will be estimated using Kaplan-Meier method

Serious adverse events (SAEs)according to NCI CTCAE v5.0, by grade and their relationship to PLX038

Incidence of efficacy of PLX038 in pre-defined biomarker subgroups (BRCAness)

Maximum Plasma Concentration effect of PLX038

DoR is defined as the time from the first documented PR or CR until the date of disease progression or the date of death. DoR will be computed using Kaplan-Meier

PFS is defined as the time from inclusion to progression (per RECIST 1.1) or death, among included patients

PFS is defined as the time from inclusion to the first event among progression and death. OS is defined in the same way but only death is taken into account.

Adverse events (AEs) according to NCI CTCAE v5.0, by grade and their relationship to PLX038

Incidence of efficacy of PLX038 in pre-defined biomarker subgroups (SLFN11 expression)

Incidence of efficacy of PLX038 in pre-defined biomarker subgroups (RB1 loss)

Maximum Plasma Concentration of effect of PLX038

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase I Study of PLX038 in Patients With Advanced Solid Tumors	NCT02646852	Tumors Neoplasms Cancer	PLX038	18 Years -	ProLynx LLC
A Study to Evaluate the Efficacy and Toxicities of PLX038, in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer	NCT06162351	Breast Cancer	PLX038	18 Years -	Institut Curie

Spots Global Cancer Trial Database for plx038

Every month we try and update this database with for plx038 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for plx038

Every month we try and update this database with for plx038 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for plx038 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.