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B-cell Lymphoid MalignanciesPhase 1NCT05263739

A First-in-Human Phase I Study of ESG206 in Subjects With B-cell Lymphoid Malignancies

A Phase 1 study testing ESG206 in people with B-cell Lymphoid Malignancies, run by Shanghai Escugen Biotechnology Co., Ltd.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a first-in-human phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The purpose is to evaluate the clinical safety, tolerability, PK, and preliminary efficacy and to establish the MTD, if any, and RP2D(s) of ESG206 in adult subjects with B lymphoid malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Lymphoid Malignancies
What is being tested?
ESG206
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2025to Dec 2026
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent for the trial.
  • Male or female and at least 18 years of age.
  • Subjects must have a histologically confirmed (or documented), incurable B-cell hematologic malignancy that had progressed despite standard of care therapy and for which there was no alternative therapy of proven benefit or no effective standard therapy is available or tolerable.
  • Measurable or evaluable Disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subject must have adequate organ function.

Who cannot join

  • Has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days before first dosing.
  • Had major surgery within 4 weeks before first dosing.
  • Had undergone an autologous stem cell transplant within 100 days before first dosing.
  • Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, or renal disease).
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients.
  • Pregnant or breastfeeding women.
  • Unwillingness or inability to follow the procedures outlined in the protocol.

About this study

Official title: A First-in-Human Phase I, Open Label, Multiple Dose, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of Anti-BAFFR mAb, ESG206 in Subjects With B-cell Lymphoid Malignancies

This is a first-in-human phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The purpose is to evaluate the clinical safety, tolerability, PK, and preliminary efficacy and to establish the MTD, if any, and RP2D(s) of ESG206 in adult subjects with B lymphoid malignancies.

Read the detailed description

This is a first-in-human phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The study will follow a modified 3+3 dose escalation scheme. Dose escalation will continue until identification of MTD or the predicted efficacy dose in the event that a MTD is not identified due to paucity of DLTs. Toxicity including dose-limiting toxicity (DLT) observed in Cycle 1 of the first 28 days will be used to determine escalation to the next dose level as described below.

Five dose levels are planned. Dose choosing will be determined by the SMC and the sponsor based on the pharmacokinetics, tolerability and preliminary antitumor activities, as well as other available data.

Subjects will be monitored for safety, tolerability, and efficacy throughout the study.

Being tested
ESG206

What participants receive

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

  • ESG206Drug

    Administered via intravenous (IV) infusion

Study groups in NCT05263739
Study groupRoleWhat they receive
ESG206 dose level 1ExperimentalESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle.
Receives: Drug: ESG206
ESG206 dose level 2ExperimentalESG206 will be administered intravenously at dose level 2 every two weeks in a 28-day cycle.
Receives: Drug: ESG206
ESG206 dose level 3ExperimentalESG206 will be administered intravenously at dose level 3 every two weeks in a 28-day cycle.
Receives: Drug: ESG206
ESG206 dose level 4ExperimentalESG206 will be administered intravenously at dose level 4 every two weeks in a 28-day cycle.
Receives: Drug: ESG206
ESG206 dose level 5ExperimentalESG206 will be administered intravenously at dose level 5 every two weeks in a 28-day cycle.
Receives: Drug: ESG206

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

    Treatment-emergent adverse events (TEAEs) were defined as: Any AE that happens after treatment initiation,.or AE that was present at time of treatment initiation but worsened after treatment initiation, or AE that was present and resolved prior to treatment and reappeared after treatment initiation 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.

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

Secondary outcomes (7)

  1. Cmax

    Maximum observed plasma concentration

    Measured: Up to 20 months

  2. AUC0-inf

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

    Measured: Up to 20 months

  3. Tmax

    Time to maximum plasma concentration

    Measured: Up to 20 months

  4. T1/2

    Half-life

    Measured: Up to 20 months

  5. Overall Response (OR)

    Defined as complete response (CR) + partial response (PR)

    Measured: Up to 20 months

  6. Progression-free Survival (PFS)

    Defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression or death from any cause

    Measured: Up to 20 months

  7. ADA

    Incidence of anti-drug antibodies

    Measured: Up to 20 months

Timeline

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

  1. First posted3 Mar 2022
  2. Study startDec 2025 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: Due to the company's development strategy adjustment

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05263739
Sponsor's protocol ID
ESG206-101
Status last verified
Sep 2025
First submitted
18 Feb 2022
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ESG206 in people with B-cell Lymphoid Malignancies, run by Shanghai Escugen Biotechnology Co., Ltd.

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 7 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: withdrawn, 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.

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 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.

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 was withdrawn before enrolling participants, so there are no results.

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 (time frame: First dose date up to last dose plus 30 days). 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 NCT05263739.

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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