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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239194
• Other study ID #: MDX-2001-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 12, 2024
• Est. completion date: February 2029

Study information

• Verified date: June 2024
• Source: ModeX Therapeutics, An OPKO Health Company
• Contact: Email recommended
• Phone: (857) 233-9936
• Email: info[@]modextx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: February 2029
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Breast Cancer
• Carcinoma, Hepatocellular
• Cervical Cancer
• Colon Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Esophageal Cancer
• Gastric Cancer
• GastroEsophageal Cancer
• Head and Neck Cancer
• Hepatocellular Cancer
• Kidney Neoplasms
• Liver Neoplasms
• Non-small Cell Lung Cancer
• Pancreatic Cancer
• Prostate Cancer
• Rectal Cancer
• Renal Cancer
• Thyroid Cancer

Intervention

Drug:
• MDX2001
MDX2001 intravenous infusion

Locations

Country	Name	City	State
United States	NEXT Oncology	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ModeX Therapeutics, An OPKO Health Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline until end of study, up to approximately 9 months
Primary	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.	From date of enrollment until the end of treatment, up to approximately 6 months
Primary	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	Baseline until end of study, up to approximately 9 months
Secondary	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.	From date of enrollment until the end of treatment, up to approximately 6 months
Secondary	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	From date of enrollment until the end of treatment, up to approximately 6 months
Secondary	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)	From date of enrollment until the first documentation of response (CR or PR), approximately 4 months
Secondary	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	From date of enrollment until the end of treatment, up to approximately 6 months
Secondary	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	From date of enrollment until the end of treatment, up to approximately 6 months
Secondary	All Phases: Pharmacokinetic Parameter Cmax of MDX2001	Maximum observed plasma concentration	From date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 months
Secondary	All Phases: Pharmacokinetic parameter area under the curve (AUC(0-T)) of MDX2001	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
Secondary	All Phases: Evaluation of MDX2001 immunogenicity	The presence and persistence of anti-MDX2001 antibodies	Baseline until end of study, up to approximately 9 months
Secondary	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	Baseline until the end of treatment, up to approximately 6 months