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

January 26, 2024 updated by: ModeX Therapeutics, An OPKO Health Company

A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

115

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1a - MDX2001 Dose Escalation
Patients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion.
Drug: MDX2001
MDX2001 intravenous infusion
Experimental: Phase 1b - Dose Expansion - Dose A
Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion.
Drug: MDX2001
MDX2001 intravenous infusion
Experimental: Phase 1b - Dose Expansion - Dose B
Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion.
Drug: MDX2001
MDX2001 intravenous infusion
Experimental: Phase 2a - Cohort Expansion
Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion at the recommended Phase 2 dose.
Drug: MDX2001
MDX2001 intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Phases: Adverse events (AEs)
Time Frame: Baseline until end of study, up to approximately 9 months
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
Baseline until end of study, up to approximately 9 months
Phase 1b and Phase 2a: Objective response rate of MDX2001
Time Frame: From date of enrollment until the end of treatment, up to approximately 6 months
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.
From date of enrollment until the end of treatment, up to approximately 6 months
Phase 1: Recommended Phase 2 dose (RP2D)
Time Frame: Baseline until end of study, up to approximately 9 months
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
Baseline until end of study, up to approximately 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1a: Objective response rate of MDX2001
Time Frame: From date of enrollment until the end of treatment, up to approximately 6 months
Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per RECIST v1.1.
From date of enrollment until the end of treatment, up to approximately 6 months
All Phases: Duration of response (DOR)
Time Frame: From date of enrollment until the end of treatment, up to approximately 6 months
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
From date of enrollment until the end of treatment, up to approximately 6 months
All Phases: Time to response (TTR)
Time Frame: From date of enrollment until the first documentation of response (CR or PR), approximately 4 months
Time to response is defined as the time from first dose to first documentation of response (CR or PR)
From date of enrollment until the first documentation of response (CR or PR), approximately 4 months
All Phases: Disease control rate (DCR)
Time Frame: From date of enrollment until the end of treatment, up to approximately 6 months
Disease control rate is defined as the proportion of evaluable patients with a best overall response (BOR) of stable disease, CR or PR
From date of enrollment until the end of treatment, up to approximately 6 months
All Phases: Progression free survival (PFS)
Time Frame: From date of enrollment until the end of treatment, up to approximately 6 months
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
From date of enrollment until the end of treatment, up to approximately 6 months
All Phases: Pharmacokinetic Parameter Cmax of MDX2001
Time Frame: From date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 months
Maximum observed plasma concentration
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
Time Frame: From date of enrollment until the completion of the 3rd cycle of treatment, up to approximately 3 months
Area under the plasma concentration versus time curve
From date of enrollment until the completion of the 3rd cycle of treatment, up to approximately 3 months
All Phases: Evaluation of MDX2001 immunogenicity
Time Frame: Baseline until end of study, up to approximately 9 months
The presence and persistence of anti-MDX2001 antibodies
Baseline until end of study, up to approximately 9 months
All Phases: Correlation between tumor antigen expression and anti-tumor activity of MDX2001
Time Frame: Baseline until the end of treatment, up to approximately 6 months
Relationship between H score cell surface target protein expression in tumor tissue at baseline and objective responses with MDX2001
Baseline until the end of treatment, up to approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModeX Therapeutics, An OPKO Health Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDX-2001-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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