Recruiting
Phase 1
Phase 2

MDX2001

Sponsor:

ModeX Therapeutics, An OPKO Health Company

Code:

NCT06239194

Conditions

Biliary Tract Cancer

Breast Cancer

Cervical Cancer

Colon Cancer

Endometrial Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MDX2001

Study Details

Brief summary:

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

Conditions

Biliary Tract Cancer

Breast Cancer

Cervical Cancer

Colon Cancer

Endometrial Cancer

Study ID

NCT06239194

Start date

Jun 12, 2024

Status verified date

May, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

285 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a - MDX2001 Dose Escalation

Patients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion.

experimental: Phase 1b - Indication Optimization

Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion.

experimental: Phase 1b - Dose Optimization

Patients with a single tumor indication will receive MDX2001 as intravenous (IV) 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.

Interventions

MDX2001

MDX2001 intravenous infusion

Primary outcome measure

  • All Phases: Adverse events (AEs) [ Time Frame: Baseline until end of study, up to approximately 9 months ]
  • 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 ]
  • Phase 1: Recommended Phase 2 dose (RP2D) [ Time Frame: Baseline until end of study, up to approximately 9 months ]

Central Contacts and Locations

Central contacts

Email recommended

(857) 233-9936info@modextx.com

Locations

Sarah Cannon Research Institute

Recruiting

Denver, Colorado, United States, 80218

Contacts

ModeX Therapeutics

+1 857-233-9936info@modextx.com

Principal Investigator:

Gerald Falchook, MD

Sylvester Comprehensive Cancer Center - University of Miami Health System

Recruiting

Miami, Florida, United States, 33136

Contacts

ModeX Therapeutics

+1 857-233-9936info@modextx.com

Principal Investigator:

Jaime Merchan, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

ModeX Therapeutics

+1 857-233-9936info@modextx.com

Principal Investigator:

Rebecca Heist, MD, MPH

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

ModeX Therapeutics

+1 857-233-9936info@modextx.com

Principal Investigator:

Melissa Johnson, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

ModeX Therapeutics

+1 857-233-9936info@modextx.com

Principal Investigator:

Ecaterina Dumbrava, MD

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

ModeX Therapeutics

+1 857-233-9936info@modextx.com

Principal Investigator:

David Sommerhalder, MD

More Information

Sponsor

ModeX Therapeutics, An OPKO Health Company

Last update posted

May 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ModeX Therapeutics, An OPKO Health Company on 2026-05-06.