2024-06-12
2028-08
2029-02
115
NCT06239194
ModeX Therapeutics, An OPKO Health Company
ModeX Therapeutics, An OPKO Health Company
INTERVENTIONAL
Dose Escalation and Dose Expansion Study of MDX2001 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.
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).
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-01-18 | N/A | 2024-08-26 |
2024-01-26 | N/A | 2024-08-28 |
2024-02-02 | N/A | 2024-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Sequential
Masking:
None
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
|
| EXPERIMENTAL: Phase 1b - Dose Expansion - Dose A Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion. | DRUG: MDX2001
|
| EXPERIMENTAL: Phase 1b - Dose Expansion - Dose B Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion. | DRUG: MDX2001
|
| 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| All Phases: Evaluation of MDX2001 immunogenicity | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Email recommended Phone Number: (857) 233-9936 Email: info@modextx.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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