Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors

Phase 2RecruitingNCT06239194

ModeX Therapeutics, An OPKO Health Company115 enrolled

Overview

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.

This study consists of Phase 1a dose escalation, Phase 1b dose expansion in a single indication, and Phase 2a expansion in a single indication. Primary Objectives * All Phases: Evaluate the safety and tolerability of MDX2001 in patients with advanced solid tumor malignancies * Phase 1 only: Identify a recommended Phase 2 dose (RP2D) for further development of MDX2001 * For Phase 1b and Phase 2: Assess the anti-tumor efficacy of MDX2001 in patients with selected advanced solid tumor malignancies Secondary Objectives: * Further characterize the anti-tumor activity of MDX2001 based on additional assessments of clinical benefit * Characterize the pharmacokinetics of MDX2001 * Characterize the immunogenicity of MDX2001 * Characterize relationship of baseline target protein expression in tumor tissue and clinical benefit The expected duration of study intervention for patients may vary, based on progression date. The median expected duration of study per patient is estimated to be 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Biliary Tract Cancer Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must be ≥ 18 years of age * Histologically or cytologically confirmed diagnosis of metastatic solid tumors * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * All patients should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion. * All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Adequate hematologic, hepatic and renal function * Capable of giving signed informed consent Exclusion Criteria: * Any clinically significant cardiac disease * Unresolved toxicities from previous anticancer therapy * Prior solid organ or hematologic transplant * Known untreated, active, or uncontrolled brain metastases * Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectious requiring intravenous treatment. * Receipt of a live-virus vaccination within 28 days of planned treatment start * Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions. * Participation in a concurrent clinical study in the treatment period. * Known hypersensitivity to MDX2001 or any of its ingredients The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Locations (6)

Sarah Cannon Research Institute

Denver, Colorado, United States

RECRUITING

Sylvester Comprehensive Cancer Center - University of Miami Health System

Miami, Florida, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

All Phases: Adverse events (AEs)

Incidence and severity of AEs and serious AEs (SAEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 including changes in clinical laboratory parameters

Time frame: Baseline until end of study, up to approximately 9 months

Phase 1b and Phase 2a: Objective response rate of MDX2001

Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Time frame: From date of enrollment until the end of treatment, up to approximately 6 months

Phase 1: Recommended Phase 2 dose (RP2D)

Recommended Phase 2 dose is determined following the evaluation of MDX2001 safety including the incidences of dose limiting toxicities (DLTs), MDX2001 anti-tumor activity, and MDX2001 pharmacokinetics

Time frame: Baseline until end of study, up to approximately 9 months

Secondary Outcomes

Phase 1a: Objective response rate of MDX2001

Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per RECIST v1.1.

Time frame: From date of enrollment until the end of treatment, up to approximately 6 months

All Phases: Duration of response (DOR)

Duration of response is defined as the time from first documentation of response (complete response \[CR\] or partial response \[PR\]) to documentation of objective disease progression or death due to any cause, whichever occurs first

Time frame: From date of enrollment until the end of treatment, up to approximately 6 months

All Phases: Time to response (TTR)

Time to response is defined as the time from first dose to first documentation of response (CR or PR)

Time frame: From date of enrollment until the first documentation of response (CR or PR), approximately 4 months

All Phases: Disease control rate (DCR)

Disease control rate is defined as the proportion of evaluable patients with a best overall response (BOR) of stable disease, CR or PR

Time frame: From date of enrollment until the end of treatment, up to approximately 6 months

All Phases: Progression free survival (PFS)

Progression-free survival is defined as the time from the first dose to the date of disease progression or death (any cause), whichever occurs first

Time frame: From date of enrollment until the end of treatment, up to approximately 6 months

All Phases: Pharmacokinetic Parameter Cmax of MDX2001

Maximum observed plasma concentration

Time frame: From date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 months

All Phases: Pharmacokinetic parameter area under the curve (AUC(0-T)) of MDX2001

Area under the plasma concentration versus time curve

Time frame: From date of enrollment until the completion of the 3rd cycle of treatment, up to approximately 3 months

All Phases: Evaluation of MDX2001 immunogenicity

The presence and persistence of anti-MDX2001 antibodies

Time frame: Baseline until end of study, up to approximately 9 months

All Phases: Correlation between tumor antigen expression and anti-tumor activity of MDX2001

Relationship between H score cell surface target protein expression in tumor tissue at baseline and objective responses with MDX2001

Time frame: Baseline until the end of treatment, up to approximately 6 months

Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts