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NCT Number: NCT06239194

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.

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Key information

Conditions

Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cervical Cancer Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer GastroEsophageal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Head and Neck Cancer Head and Neck Neoplasms Hepatocellular Cancer Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Cancer Rectal Diseases Rectal Neoplasms Renal Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sarah Cannon Research Institute, Denver, Colorado, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 infectiion 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
  • Supplemental oxygen use for activities of daily living

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Treatment and study plan

MDX2001

Drug

MDX2001 intravenous infusion

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Email recommended

CONTACT

[email protected]

(857) 233-9936

Sponsors and collaborators

Lead sponsor

ModeX Therapeutics, An OPKO Health Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Feb 2, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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