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Experimental cancer drug KD033 tested in early trial – but study halted

NCT ID NCT04242147

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase study tested an experimental drug called KD033 (SAR445710) in 45 adults with advanced or metastatic solid tumors. The main goal was to check safety and find the right dose, while also looking for any anti-cancer effects. The trial was terminated, so final results may be limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KD033 (SAR445710)
What this could lead to
If it works, this could point toward a new treatment option for advanced solid tumors.
What could go wrong
This is a very early Phase 1 trial, so safety and effectiveness are not yet proven. The study was terminated, meaning results may be limited or inconclusive.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

45 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2023

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically or cytologically confirmed/documented advanced and/or metastatic solid tumor with at least one tumor lesion of location accessible to biopsy per clinical judgement of treating physician. * Participants must be willing to provide a tumor biopsy at the following time points: Pre-treatment and at Cycle 4, Day 1. All other study eligibility criteria must be met before any biopsy sample is obtained. * Measurable disease at baseline per RECIST v1.1 guidelines. * Life expectancy of at least 3 months. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ≤ 1. * Adequate organ and bone marrow functions. * All toxicities related to prior radiotherapy, chemotherapy, or surgical procedure must have recovered to baseline or Grade ≤ 1 based on NCI-CTCAE v5.0 except alopecia (any grade), Grade 2 peripheral neuropathy and adverse events that are clinically non-significant or stable on supportive care. * All participants, male and female, who are not surgically sterilized or postmenopausal must agree to use 'highly effective methods of contraception' during the study and for at least 60 days after the last dose of KD033 (SAR445710). * Women of childbearing potential must have a negative pregnancy test within 7 days prior to KD033 (SAR445710) treatment. * Ability to understand the purpose of the study, provide signed and dated informed consent from the participant/legal representative prior to performing any protocol-related procedures and able to comply with the study procedures and any locally required authorization. Exclusion Criteria: * Use of immunotherapy, biological therapy, cytokine therapy \< 21 days prior to the first dose of study drug. * Use of immunomodulating agents \< 21 days prior to the first dose of study drug. * Use of chemotherapy and approved tyrosine kinase inhibitor (TKI) therapy \< 14 days prior to the first dose of study drug. * Anti PD-L1 or anti PD-1 therapy \< 6 weeks prior to the first dose of study drug. * Radiotherapy within 14 days before the start of trial treatment (prior diagnostic biopsy is permitted), with the exception of palliative radiation as described: patients assigned to radiotherapy require at least 1 additional lesion that can be safely irradiated while sparing the index lesion(s), and for which radiation at the limited, palliative doses contemplated would be considered medically appropriate; The lesion should be causing some signs or symptoms (e.g., tumor-related pain), for which radiation is indicated per the physician's standard clinical practice. * Use of any investigational drug or have major surgery within 28 days before the start of trial treatment * Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required systemic immunosuppressive treatments. * Systemic therapy with immunosuppressive agents including corticosteroids within 14 days before the start of trial treatment with the exception of corticosteroid replacement therapy for adrenal insufficiency * Rapidly progressive disease which, in the opinion of Investigator, may predispose to inability to tolerate treatment or trial procedure. * History or clinical evidence of central nervous system primary tumors or metastases including leptomeningeal metastases unless they have been previously treated, demonstrated no progression at least 1 months, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before Screening - Participants with suspected brain metastases at Screening should undergo a CT/MRI of the brain prior to study entry. * Receipt of any organ transplantation including hematopoietic cell transplantation. * Has a paraneoplastic syndrome of autoimmune nature. * History of interstitial lung disease or severe obstructive pulmonary disease. * Clinically significant cardiovascular/cerebrovascular disease. * QTc(F) interval \> 450 ms for men or \> 470 ms for women) * Left ventricular ejection fraction (LVEF) \< 50% as measured by an echocardiogram (ECHO). * Active infection requiring therapy. * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding. * Pregnant or breast-feeding women * Known severe hypersensitivity reactions to monoclonal antibodies, any history of or recent (within 6 months) of anaphylaxis * Vaccine administration within 4 weeks of investigational drug administration. * Vaccination with live vaccines while on trial is prohibited. Administration of inactivated vaccines like inactivated influenza vaccines is allowed. COVID-19 vaccines are approved to be administered prior to KD033 (SAR445710) administration and during the treatment phase, however, it is preferred to not vaccinate during the 28-day DLT period. Note: Other protocol-defined exclusion criteria could apply.

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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.

Contacts and locations

Locations

  • Fox Chase Cancer Center - 333 Cottman Avenue - Site 141

    Philadelphia, Pennsylvania, 19111, United States

  • Moffitt Cancer Center - Site 102

    Tampa, Florida, 33612, United States

  • Roswell Park Cancer Institute - 665 Elm St - Site 062

    Buffalo, New York, 14263, United States

  • UCLA Hematology/Oncology, 2020 Santa Monica Boulevard, Suite 600 - Site 042

    Santa Monica, California, 90404, United States

  • University of Pittsburgh Medical Center - Hillman Cancer Center - 5150 Centre Avenue, Suite 301 - Site 132

    Pittsburgh, Pennsylvania, 15232, United States

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Other studies related to the condition(s) this trial covers.