Clinical trial NCT06239194: Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
Official title: A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Biliary Tract Cancer
Breast Cancer
Cervical Cancer
Colon Cancer
Endometrial Cancer
Esophageal Cancer
Gastric Cancer
GastroEsophageal Cancer
Head and Neck Cancer
Hepatocellular Cancer
Non-small Cell Lung Cancer
Pancreatic Cancer
Prostate Cancer
Rectal Cancer
Renal Cancer
Thyroid Cancer
Lead sponsor: ModeX Therapeutics, An OPKO Health Company
Sponsor class: INDUSTRY
First posted: 2024-02-02
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: All Phases: Adverse events (AEs)
timeFrame: Baseline until end of study, up to approximately 9 months
measure: Phase 1b and Phase 2a: Objective response rate of MDX2001
timeFrame: From date of enrollment until the end of treatment, up to approximately 6 months
measure: Phase 1: Recommended Phase 2 dose (RP2D)
timeFrame: Baseline until end of study, up to approximately 9 months
Secondary outcomes:
measure: Phase 1a: Objective response rate of MDX2001
timeFrame: From date of enrollment until the end of treatment, up to approximately 6 months
measure: All Phases: Duration of response (DOR)
timeFrame: From date of enrollment until the end of treatment, up to approximately 6 months
measure: All Phases: Time to response (TTR)
timeFrame: From date of enrollment until the first documentation of response (CR or PR), approximately 4 months
measure: All Phases: Disease control rate (DCR)
timeFrame: From date of enrollment until the end of treatment, up to approximately 6 months
measure: All Phases: Progression free survival (PFS)
timeFrame: From date of enrollment until the end of treatment, up to approximately 6 months
measure: All Phases: Pharmacokinetic Parameter Cmax of MDX2001
timeFrame: From date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 months
measure: All Phases: Pharmacokinetic parameter area under the curve (AUC(0-T)) of MDX2001
timeFrame: From date of enrollment until the completion of the 3rd cycle of treatment, up to approximately 3 months
measure: All Phases: Evaluation of MDX2001 immunogenicity
timeFrame: Baseline until end of study, up to approximately 9 months
measure: All Phases: Correlation between tumor antigen expression and anti-tumor activity of MDX2001
timeFrame: Baseline until the end of treatment, up to approximately 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Sarah Cannon Research Institute
state: Colorado
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center - University of Miami Health System
state: Florida
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
Study officials:
References: