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New treatment option for Locally Advanced/Metastatic Solid Tumors
Official title Study of ESG406 in Adults With Solid Tumors
ClinicalTrials.gov ID: NCT06979674
What this study is testing
What is ESG406?
ESG406 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced/metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort expansion study in Phase Ib.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join if
- Use of any cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy) within 4 weeks before the first investigational...
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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.
- people 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
- Xi’an, Shanxi, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China; Xi’an, Shanxi, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.