New drug MDX2001 tested in 285 patients with advanced cancers
NCT ID NCT06239194
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called MDX2001 in people with advanced solid tumors that have spread. The main goals are to check the drug's safety and see if it can shrink tumors. About 285 adults with various cancers like lung, breast, or colon cancer will take part. This is an early-stage trial, so the focus is on finding the right dose and understanding side effects, not on a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 285 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2024
- Expected to finish
-
Feb 2029
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
6 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
Contact Email: •••••@•••••
-
Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
Contact Email: •••••@•••••
-
NEXT Oncology
RECRUITINGSan Antonio, Texas, 78229, United States
Contact Email: •••••@•••••
-
Sarah Cannon Research Institute
RECRUITINGDenver, Colorado, 80218, United States
Contact Email: •••••@•••••
-
Sarah Cannon Research Institute
RECRUITINGNashville, Tennessee, 37203, United States
Contact Email: •••••@•••••
-
Sylvester Comprehensive Cancer Center - University of Miami Health System
RECRUITINGMiami, Florida, 33136, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Retrospective analysis of pyrotinib in the treatment of HER2-Positive advanced breast cancer previously treated with trastuzumab and pertuzumab
- A multicenter, Dose-Escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors
- RE-irradiation for isolated FOCal recurrence of prostate cancer with ultrahypofracted SBRT: the RE-FOCUS study - pushing the boundaries of precision and efficacy
- A prospective imaging study of target definition and radiation planning workflows on the integrated TrueBeam-HyperSight system for patients receiving radiation therapy
- A phase II/III randomized clinical trial of CisPlatin plUs gemcitabine and nabpaclitaxel (GAP) as pReoperative chemotherapy versus immediate resection in patIents with resecTable BiliarY tract cancers (BTC) at high risk for recurrence: PURITY study
- A phase II study of total neoadjuvant mFOLFOX6 plus suvemcitug and enlonstobart with selective omission of pelvic radiotherapy for High-Risk Mid-Rectal locally advanced rectal cancer with MSS status