B-cell Lymphoid MalignanciesPhase 1NCT05822843
A Phase 1 Study of ESG206 in Adult 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 at 1 site in China.
Trial summary
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… 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
- 13 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2023to 22 Jan 2025
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- B-cell Lymphoid Malignancies
- 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 group | Role | What they receive |
|---|---|---|
| ESG206 dose level 1 | Experimental | ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle Receives: Drug: ESG206 |
| ESG206 dose level 2 | Experimental | ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle Receives: Drug: ESG206 |
| ESG206 dose level 3 | Experimental | ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle Receives: Drug: ESG206 |
| ESG206 dose level 4 | Experimental | ESG206 will be administered intravenously at dose level 1 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.
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events
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.
Measured: First dose date up to last dose plus 30 days
Secondary outcomes (7)
Cmax
Maximum observed plasma concentration
Measured: Up to 20 months
AUC0-inf
Area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity
Measured: Up to 20 months
Tmax
Time to maximum plasma concentration
Measured: Up to 20 months
T1/2
Half-life
Measured: Up to 20 months
Overall Response Rate (ORR)
Defined as complete response (CR) + partial response (PR)
Measured: Up to 20 months
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
ADA
Incidence of anti-drug antibodies (ADA)
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.
- First posted21 Apr 2023
- Study start2 Aug 2023
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Lymphoid MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Escugen Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822843
- Sponsor's protocol ID
- ESG206-102
- Status last verified
- Sep 2025
- First submitted
- 10 Apr 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05822843
- Acronym / sponsor ID
- ESG206-102
- Conditions
- B-cell Lymphoid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Shanghai Escugen Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ESG206 dose level 1 | Experimental | Drug: ESG206ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle |
| ESG206 dose level 2 | Experimental | Drug: ESG206ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle |
| ESG206 dose level 3 | Experimental | Drug: ESG206ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle |
| ESG206 dose level 4 | Experimental | Drug: ESG206ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESG206Administered via intravenous (IV) infusion | Drug | ESG206 dose level 1, ESG206 dose level 2, ESG206 dose level 3, ESG206 dose level 4 |
Primary outcome
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.
7 secondary outcomes
Cmax
Time frame: Up to 20 months
AUC0-inf
Time frame: Up to 20 months
Tmax
Time frame: Up to 20 months
T1/2
Time frame: Up to 20 months
Overall Response Rate (ORR)
Time frame: Up to 20 months
Progression-free Survival (PFS)
Time frame: Up to 20 months
ADA
Time frame: Up to 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 at 1 site 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 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: 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 1 site 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 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 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 (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?
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.