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Neoplasms, BreastPhase 1/2NCT04892342

Study of ESG401 in Adults With Solid Tumors

A Phase 1/2 study testing ESG401 in people with Neoplasms, Breast and Neoplasms, Lung, run by Shanghai Escugen Biotechnology Co., Ltd at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective in Phase I is to evaluate the safety and tolerability of ESG401 as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
ESG401
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
3 sitesChina
Study dates
14 Sep 2021to 30 Jun 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals able to understand and give written informed consent.
  • Subjects must have a histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥12 weeks.
  • Subject must have adequate organ 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.

Who cannot join

  • Subjects receiving cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy, or radiation therapy) within 4 weeks before the first investigational product administration..
  • Has not recovered from adverse events (e.g., returned to baseline or grade 0~1) due to a previously administered agent.
  • Note: Subjects with Grade 2 alopecia or anemia are exceptions to this criterion and may qualify for the study.
  • 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 28 days before the first investigational product administration.
  • New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months
Show all 25Show fewer
  • Uncontrolled systemic bacterial, viral or fungal infections
  • Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases.
  • Primary CNS malignancy; Or a second primary tumor other than the confirmed solid tumor within the previous 3 years
  • Evidence of serious or uncontrolled systemic disease (e.g., unstable or decompensated respiratory disease, liver disease or kidney disease)
  • Patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea
  • History of chronic skin disease and present skin disease (e.g. bullous dermatitis, acnelike rash, skin ulcer, etc.)
  • Subjects with clinically significant cardiovascular disease as defined by the following:
  • Baseline left ventricular ejection fraction (LVEF) ≤ 50% measured by Echocardiogram (ECHO) or Multi-gated acquisition (MUGA)
  • Heart failure New York Heart Association (NYHA) Class II or above
  • Uncontrolled hypertension (BP ≥ 150/95 mmHg despite optimal therapy)
  • Prior or current cardiomyopathy
  • Atrial fibrillation with heart rate > 100 bpm
  • Unstable ischaemic heart disease (myocardial infarction (MI) within 6 months prior to starting treatment, or angina requiring use of nitrates more than once weekly)
  • QTc interval >/= 450 msecs for male or >/= 470 msecs for female (Fridericia's formula: QTc=QT/RR0.33).
  • Human Immunodeficiency Virus (HIV) infection.
  • Subjects who are Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) positive or Hepatitis C virus (HCV) antibody positive at screening must not be enrolled until further definite testing with Hepatitis B virus (HBV) DNA titres and HCV RNA tests can conclusively rule out presence of active infection (HBV DNA ≥ 1000 cps/mL or 200 IU/mL) requiring antiviral therapy with Hepatitis B and C, respectively
  • Known immediate or delayed hypersensitivity reaction to irinotecan or other camptocampin derivatives such as topotecan or to have had grade ≥3 gastrointestinal reactions associated with irinotecan, or allergies, or to any investigational drug or excipient ingredient
  • Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
  • Unwillingness or inability to follow the procedures outlined in the protocol.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG401 in Subjects With Locally Advanced/Metastatic Solid Tumors

The primary objective in Phase I is to evaluate the safety and tolerability of ESG401 as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of ESG401 administered in 21-day treatment cycles at a dose selected in Phase I.

Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).

Being tested
ESG401
Medical subject headings
Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Urinary Bladder Neoplasms, Stomach Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ESG401Drug

    Administered via intravenous (IV) infusion

Study groups in NCT04892342
Study groupRoleWhat they receive
ESG401 dose level 1ExperimentalNot described
Receives: Drug: ESG401
ESG401 dose level 2ExperimentalNot described
Receives: Drug: ESG401
ESG401 dose level 3ExperimentalNot described
Receives: Drug: ESG401
ESG401 dose level 4ExperimentalNot described
Receives: Drug: ESG401
ESG401 dose level 5ExperimentalNot described
Receives: Drug: ESG401
ESG401 dose level 6ExperimentalNot described
Receives: Drug: ESG401
ESG401 dose level 7ExperimentalNot described
Receives: Drug: ESG401
ESG401 dose level 8ExperimentalNot described
Receives: Drug: ESG401
ESG401 dose level 9ExperimentalNot described
Receives: Drug: ESG401
ESG401 dose level 10ExperimentalNot described
Receives: Drug: ESG401

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events

    Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. An AE that met one or more of the following outcomes was classified as serious:

    Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above

    Measured: First dose date up to last dose plus 30 days

  2. Objective Response Rate (ORR) by Independent Central Review (ICR)

    ORR is defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to <10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by ICR will be assessed for the TNBC Target Population in phase 2 only.

    Measured: Up to 49 months

Secondary outcomes (6)

  1. Cmax

    Maximum observed plasma concentration

    Measured: Up to 49 months

  2. AUC0-inf

    Area under the serum concentration time curve from time 0 extrapolated to infinity

    Measured: Up to 49 months

  3. Objective Response Rate by Local Assessment

    ORR is defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to <10 mm. PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by local assessment will be assessed for the Target Population both in phase 1 and phase 2.

    Measured: Up to 49 months

  4. Progression Free Survival (PFS) by Local Assessment

    Progression-free survival (PFS) is defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.

    Measured: Up to 49 months

  5. Overall Survival by Local Assessment

    Overall survival is defined as the time from the date of the first dose start date to the date of death due to any cause.

    Measured: Up to 49 months

  6. ADA

    Incidence of anti-drug antibodies

    Measured: Up to 49 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2021
  2. Study start14 Sep 2021
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Sequential Assignment
Masking
None (open label)
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04892342
Sponsor's protocol ID
ESG401-101
Status last verified
May 2025
First submitted
13 May 2021
Last updated
12 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang J, Zhang Y, Bai R, Wu Y, Tong Z, Liu A, Zhang Y, Wang H, Wu X, Cheng Y, Yang H, Zhou Q, Xing X, Chen X, Qiu F, Ma F. Novel TROP2 antibody-drug conjugates for treatment of HER2-negative metastatic breast cancer patients with brain metastases: a promising option☆. ESMO Open. 2025 May;10(5):105059. doi: 10.1016/j.esmoop.2025.105059. Epub 2025 May 12.

    PubMed 40359710

  • Wang J, Tong Z, Tan Y, Shi Y, Wu Y, Zhou Q, Xing X, Chen X, Qiu F, Ma F. Phase 1a study of ESG401, a Trop2 antibody-drug conjugate, in patients with locally advanced/metastatic solid tumors. Cell Rep Med. 2024 Sep 17;5(9):101707. doi: 10.1016/j.xcrm.2024.101707. Epub 2024 Aug 30.

    PubMed 39216478

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ESG401 in people with Neoplasms, Breast and Neoplasms, Lung, run by Shanghai Escugen Biotechnology Co., Ltd at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events (time frame: First dose date up to last dose plus 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04892342, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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