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Completed

NCT Number: NCT05822843

A Phase 1 Study of ESG206 in Adult Subjects With B-cell Lymphoid Malignancies

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

ESG206

Drug

Administered via intravenous (IV) infusion

Primary outcomes

  1. Percentage of Participants Experiencing Any Treatment Emergent Adverse Events

    Time frame: First dose date up to last dose plus 30 days

    Treatment-emergent adverse events (TEAEs) were defined as: Any adverse event (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.

Secondary outcomes

  1. Cmax

    Time frame: Up to 20 months

    Maximum observed plasma concentration

  2. AUC0-inf

    Time frame: Up to 20 months

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

  3. Tmax

    Time frame: Up to 20 months

    Time to maximum plasma concentration

  4. T1/2

    Time frame: Up to 20 months

    Half-life

  5. Overall Response Rate (ORR)

    Time frame: Up to 20 months

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

  6. Progression-free Survival (PFS)

    Time frame: Up to 20 months

    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

  7. ADA

    Time frame: Up to 20 months

    Incidence of anti-drug antibodies (ADA)

Sponsors and collaborators

Lead sponsor

Shanghai Escugen Biotechnology Co., Ltd

Industry

Registry information

Official study title

A Phase I, Open Label, Multiple Dose, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of Anti-BAFFR mAb(Monoclonal Antibody), ESG206 in Subjects With B-cell Lymphoid Malignancies

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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