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

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ClinicalTrials.gov Identifier: NCT06239194
Recruitment Status : Not yet recruiting
First Posted : February 2, 2024
Last Update Posted : February 2, 2024
Sponsor:
Information provided by (Responsible Party):
ModeX Therapeutics, An OPKO Health Company

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

Condition or disease Intervention/treatment Phase
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 Drug: MDX2001 Phase 1 Phase 2

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : August 2028
Estimated Study Completion Date : February 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1a - MDX2001 Dose Escalation
Patients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion.
 Drug: MDX2001
MDX2001 intravenous infusion
Experimental: Phase 1b - Dose Expansion - Dose A
Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion.
 Drug: MDX2001
MDX2001 intravenous infusion
Experimental: Phase 1b - Dose Expansion - Dose B
Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion.
 Drug: MDX2001
MDX2001 intravenous infusion
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
MDX2001 intravenous infusion


Outcome Measures
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Primary Outcome Measures :
  1. All Phases: Adverse events (AEs) [ Time Frame: 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

  2. Phase 1b and Phase 2a: Objective response rate of MDX2001 [ Time Frame: 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.

  3. Phase 1: Recommended Phase 2 dose (RP2D) [ Time Frame: 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 :
  1. Phase 1a: Objective response rate of MDX2001 [ Time Frame: 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.

  2. All Phases: Duration of response (DOR) [ Time Frame: 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

  3. All Phases: Time to response (TTR) [ Time Frame: 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)

  4. All Phases: Disease control rate (DCR) [ Time Frame: 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

  5. All Phases: Progression free survival (PFS) [ Time Frame: 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

  6. All Phases: Pharmacokinetic Parameter Cmax of MDX2001 [ Time Frame: From date of enrollment until completion of the 6th cycle of treatment, up to approximately 6 months ]
    Maximum observed plasma concentration

  7. All Phases: Pharmacokinetic parameter area under the curve (AUC(0-T)) of MDX2001 [ Time Frame: 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

  8. All Phases: Evaluation of MDX2001 immunogenicity [ Time Frame: Baseline until end of study, up to approximately 9 months ]
    The presence and persistence of anti-MDX2001 antibodies

  9. All Phases: Correlation between tumor antigen expression and anti-tumor activity of MDX2001 [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06239194


Contacts
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Contact: Email recommended (857) 233-9936 info@modextx.com

Sponsors and Collaborators
ModeX Therapeutics, An OPKO Health Company
More Information
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Responsible Party: ModeX Therapeutics, An OPKO Health Company
ClinicalTrials.gov Identifier: NCT06239194    
Other Study ID Numbers: MDX-2001-101
First Posted: February 2, 2024    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Biliary Tract Neoplasms
Kidney Neoplasms
Liver Neoplasms
Carcinoma, Hepatocellular
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases
Digestive System Neoplasms
Digestive System Diseases
Uterine Neoplasms
 Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Biliary Tract Diseases
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Diseases