Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
- Conditions
- Biliary Tract CancerBreast CancerColon CancerHead and Neck CancerPancreatic CancerRectal CancerThyroid CancerHepatocellular CancerNon-small Cell Lung CancerCervical Cancer
- Interventions
- Registration Number
- NCT06239194
- Lead Sponsor
- ModeX Therapeutics, An OPKO Health Company
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 115
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1a - MDX2001 Dose Escalation MDX2001 Patients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion. Phase 2a - Cohort Expansion MDX2001 Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion at the recommended Phase 2 dose. Phase 1b - Dose Expansion - Dose A MDX2001 Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion. Phase 1b - Dose Expansion - Dose B MDX2001 Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion.
- Primary Outcome Measures
Name Time Method All Phases: Adverse events (AEs) 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
Phase 1b and Phase 2a: Objective response rate of MDX2001 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.
Phase 1: Recommended Phase 2 dose (RP2D) 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
- Secondary Outcome Measures
Name Time Method All Phases: Time to response (TTR) 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)
All Phases: Disease control rate (DCR) 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
All Phases: Pharmacokinetic Parameter Cmax of MDX2001 From date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 months Maximum observed plasma concentration
All Phases: Pharmacokinetic parameter area under the curve (AUC(0-T)) of MDX2001 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
All Phases: Evaluation of MDX2001 immunogenicity Baseline until end of study, up to approximately 9 months The presence and persistence of anti-MDX2001 antibodies
All Phases: Correlation between tumor antigen expression and anti-tumor activity of MDX2001 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
Phase 1a: Objective response rate of MDX2001 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.
All Phases: Duration of response (DOR) 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
All Phases: Progression free survival (PFS) 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
Trial Locations
- Locations (4)
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Sylvester Comprehensive Cancer Center - University of Miami Health System
🇺🇸Miami, Florida, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
NEXT Oncology
🇺🇸San Antonio, Texas, United States