New drug ESG406 enters human testing for Hard-to-Treat cancers
NCT ID NCT06979674
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial is testing a new drug called ESG406 in 556 adults with advanced or metastatic solid tumors that have not responded to standard treatments. The study will first find a safe dose, then expand to see if the drug can shrink tumors. The main focus is on safety and tolerability, with tumor response as a secondary goal.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ESG406 (a drug given by IV infusion)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial, so the main goal is safety, not effectiveness. Many drugs fail at this stage, and side effects are unknown. Results may not apply to all tumor types.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 556 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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.
Key Inclusion Criteria: * Males and females aged 18 to 80 years. * Histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable. * At least one measurable lesion per RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy ≥12 weeks. * Adequate organ and bone marrow function. * Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last investigational product administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Key Exclusion Criteria: * Use of any cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy) within 4 weeks before the first investigational product administration. * Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1. * Had major surgery within 4 weeks before dosing, or will not have fully recovered from surgery; or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration. * Use of any investigational anti-cancer drug within 4 weeks or 5 half-lives before the first investigational product administration. * A history of thromboembolic or cerebrovascular events within 6 months prior to the first dose of the investigational drug. * History of (noninfectious) interstitial pneumonia (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or suspected ILD/noninfectious pneumonitis at screening. * Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases. * Patients with Primary CNS malignancy, or patients with other malignancies within 3 years prior to the first dose. * Patients with uncontrollable systemic diseases. * Subjects with clinically significant cardiovascular disease. * Human Immunodeficiency Virus (HIV) infection. * Active hepatitis B or hepatitis C. * Have an allergic constitution, or to be allergic to any investigational drug or excipient ingredient. * Pregnant or lactating women.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Locations
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Chongqing University Cancer Hospital
RECRUITINGChongqing, Chongqing Municipality, 400030, China
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The First Affiliated Hospital of Xi 'An Jiaotong University
RECRUITINGXi’an, Shanxi, 710061, China
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The Second Affiliated Hospital, Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310009, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors