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

ModeX Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Breast Cancer; Esophageal Cancer; Biliary Tract Cancer; Colon Cancer; Hepatocellular Cancer; Endometrial Cancer; Gastric Cancer; Renal Cancer; Non-small Cell Lung Cancer; Thyroid Cancer; Head and Neck Cancer; GastroEsophageal Cancer; Prostate Cancer; Cervical Cancer; Rectal Cancer; Pancreatic Cancer

Treatments: Drug: MDX2001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06239194

MDX-2001-101

Details and patient eligibility

About

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

Full 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).

Enrollment: 115 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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115 participants in 4 patient groups

Phase 1a - MDX2001 Dose Escalation

Experimental group

Description:

Patients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion.

Treatment:

Drug: MDX2001

Phase 1b - Dose Expansion - Dose A

Experimental group

Description:

Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion.

Treatment:

Drug: MDX2001

Phase 1b - Dose Expansion - Dose B

Experimental group

Description:

Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion.

Treatment:

Drug: MDX2001

Phase 2a - Cohort Expansion

Experimental group

Description:

Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion at the recommended Phase 2 dose.

Treatment:

Drug: MDX2001