ESG406 treatment in adults with advanced or metastatic solid tumors

An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG406 in Subjects With Locally Advanced/Metastatic Solid Tumors

This Phase 1 study will test whether ESG406 is safe and shows early signs of benefit in adults with advanced or metastatic solid tumors who have no standard treatment options.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 556 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Escugen Biotechnology Co., Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 3 sites (Chongqing, Chongqing Municipality and 2 other locations)
• Trial ID: NCT06979674 on ClinicalTrials.gov

What this trial studies

This open‑label Phase Ia/Ib study uses a dose‑escalation phase followed by cohort expansion to define the maximum tolerated dose and recommended Phase 2 dose and to explore administration schedules for ESG406. Primary objectives include characterizing safety, tolerability and pharmacokinetics; secondary objectives include preliminary anti‑tumor activity. Eligible participants are adults (18–80 years) with histologically or cytologically confirmed locally advanced or metastatic solid tumors, measurable disease by RECIST v1.1, ECOG 0–1, and adequate organ function. Key exclusions include receipt of systemic anticancer therapy within 4 weeks or unresolved toxicities from prior treatments.

Who should consider this trial

Good fit: Adults 18–80 with confirmed locally advanced or metastatic solid tumors, measurable disease, ECOG performance status 0–1, adequate organ and marrow function, and no effective standard therapy available are the intended candidates.

Not a fit: Patients who recently received systemic cancer therapy (within 4 weeks), have unresolved treatment toxicities, poor performance status, or inadequate organ function are unlikely to qualify and therefore may not benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify a safe dose and schedule of ESG406 and show early signs of tumor control that would support larger trials.

How similar studies have performed: Phase I dose‑escalation and cohort‑expansion designs have enabled other novel anticancer agents to find safe doses and sometimes show early responses, but ESG406 itself is a novel investigational agent without reported late‑stage success to date.

Eligibility criteria

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.

Where this trial is running

Chongqing, Chongqing Municipality and 2 other locations

• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• The First Affiliated Hospital of Xi 'An Jiaotong University — Xi’an, Shanxi, China (Recruiting)
• The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Fuming Qiu, PhD — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Xiaoyan Xing, PhD

Conditions Locally Advanced/Metastatic Solid Tumors