Relapsed or Refractory Multiple Myeloma (RRMM)Phase 2NCT07695740
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing YKST02 in people with Relapsed or Refractory Multiple Myeloma (RRMM), run by Excyte Biopharma Ltd at 1 site in China.
Trial summary
The goal of this Phase 2 clinical trial is to learn whether YKST02 is effective and safe in adults with relapsed or refractory multiple myeloma. The study will also evaluate how YKST02 is processed by the body (pharmacokinetics), how it affects the body (pharmacodynamics), and whether it causes the body to produce… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma (RRMM)
- What is being tested?
- YKST02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Able and willing to provide written informed consent (or consent provided by a legally authorized representative, where applicable) and comply with all study procedures.
- Diagnosis of multiple myeloma according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria.
- Relapsed or refractory multiple myeloma after at least two prior lines of therapy, including prior exposure to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
- Measurable disease as defined in the study protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Estimated life expectancy of at least 12 weeks.
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- Recovery from clinically significant toxicities related to prior anticancer therapy to an acceptable level before study treatment (except alopecia).
- Adequate hematologic, hepatic, renal, and coagulation function based on protocol-specified laboratory criteria.
- Women of childbearing potential must have a negative pregnancy test before study treatment and agree to use effective contraception during the study and for 3 months after the last dose of study treatment.
- Male participants must agree to use effective contraception during the study and for 3 months after the last dose of study treatment and must not donate sperm during this period.
Who cannot join
- Plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary light-chain (AL) amyloidosis.
- Prior treatment with any BCMA-targeted therapy, including BCMA-directed chimeric antigen receptor (CAR) T-cell therapy.
- Recent anticancer therapy, investigational medicinal product, radiotherapy, stem cell transplantation, or organ transplantation that does not meet the protocol-defined washout requirements.
- Active graft-versus-host disease (GvHD) requiring systemic treatment or clinically significant active GvHD.
- History of another malignancy within the past 5 years, except for adequately treated malignancies with negligible risk of recurrence, as specified in the protocol.
- Symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or evidence of uncontrolled CNS or leptomeningeal involvement that, in the investigator's judgment, makes the participant unsuitable for study participation.
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- History of clinically significant central nervous system disorders that may increase study risk or interfere with study participation.
- Clinically significant cardiovascular disease, including recent acute coronary syndrome or coronary revascularization, uncontrolled arrhythmias, New York Heart Association (NYHA) Class III or IV heart failure, clinically significant cardiac dysfunction, prolonged QT interval, or uncontrolled hypertension.
- Known hypersensitivity to monoclonal antibodies, human immunoglobulins, or any component of the study drug.
- Major surgery or severe trauma shortly before study treatment, or planned major surgery during the study.
- Requirement for systemic corticosteroids or other immunosuppressive therapy for conditions other than multiple myeloma that does not meet protocol requirements.
- Active hepatitis B or hepatitis C infection, positive human immunodeficiency virus (HIV) test, or other clinically significant uncontrolled infection requiring systemic therapy.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Pregnant or breastfeeding women.
- Known psychiatric illness or other conditions that may compromise the participant's ability to comply with study requirements.
- Receipt of a live or live attenuated vaccine within the protocol-defined period before the first dose of study treatment.
- Any other clinically significant medical condition, laboratory abnormality, or circumstance that, in the investigator's judgment, would make participation in the study inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100024
Wenming Chen, MD, +86-13910107759, 13910107759@163.com
Wenming Chen, MD
About this study
Official title: A Multicenter, Open-Label, Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma
The goal of this Phase 2 clinical trial is to learn whether YKST02 is effective and safe in adults with relapsed or refractory multiple myeloma. The study will also evaluate how YKST02 is processed by the body (pharmacokinetics), how it affects the body (pharmacodynamics), and whether it causes the body to produce anti-drug antibodies.
The main questions it aims to answer are:
Read more
Does YKST02 demonstrate clinical efficacy in adults with relapsed or refractory multiple myeloma? What side effects occur during treatment with YKST02? What are the pharmacokinetic, pharmacodynamic, and immunogenicity characteristics of YKST02?
Participants will:
Complete screening assessments to determine whether they are eligible for the study.
Receive YKST02 by intravenous infusion according to the study treatment schedule.
Undergo regular assessments to evaluate treatment response and monitor safety. Provide blood and urine samples for pharmacokinetic, pharmacodynamic, and immunogenicity testing.
Complete follow-up visits after treatment discontinuation to monitor disease progression and survival.
Multiple myeloma is a cancer of plasma cells that remains incurable despite advances in treatment. Although currently available therapies can improve outcomes, most patients eventually experience disease relapse or become refractory to treatment.
YKST02 is an investigational humanized bispecific antibody targeting BCMA on myeloma cells and CD3 on T cells. Simultaneous binding to BCMA and CD3 may activate T cells and promote tumor cell killing.
This is a multicenter, open-label study consisting of two parts (Phase IIa and Phase IIb). In Phase IIa, participants will initially receive YKST02 at the starting dose level. Safety and efficacy data from this part of the study will be reviewed to determine the dose to be evaluated in Phase IIb.
Read the detailed description
Relapsed or refractory multiple myeloma (RRMM) remains an incurable plasma cell malignancy despite substantial advances in treatment. Although currently available therapies, including proteasome inhibitors, immunomodulatory agents, anti-CD38 monoclonal antibodies, autologous stem cell transplantation, and B-cell maturation antigen (BCMA)-targeted therapies, have improved clinical outcomes, most patients eventually experience disease progression or relapse. Therefore, additional treatment options remain needed.
BCMA is highly expressed on malignant plasma cells and has emerged as an important therapeutic target for multiple myeloma.
YKST02 is an investigational humanized bispecific antibody targeting BCMA on myeloma cells and CD3 on T cells. Through simultaneous binding to BCMA and CD3, YKST02 is intended to redirect T cells to BCMA-expressing tumor cells, resulting in T-cell activation and tumor cell killing.
This is a multicenter, open-label, Phase 2 study designed to evaluate the efficacy, safety, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of YKST02 in adults with relapsed or refractory multiple myeloma.
Approximately 39 to 64 participants will be enrolled across multiple study centers in China, depending on the number of dose cohorts evaluated in Phase IIa.
The study consists of two parts. Phase IIa is designed to evaluate the safety and efficacy of YKST02 and to support selection of the dose for further evaluation in Phase IIb. Phase IIb will further evaluate the efficacy, safety, pharmacokinetics, immunogenicity, and pharmacodynamics of YKST02 at the selected dose.
Participants who meet all eligibility criteria will receive YKST02 according to the protocol-defined treatment schedule and undergo regular efficacy and safety assessments throughout the study. Blood and urine samples will be collected for pharmacokinetic, pharmacodynamic, and immunogenicity evaluations.
Participants will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, completion of the protocol-defined treatment period, or another protocol-defined discontinuation criterion. After treatment discontinuation, participants will enter follow-up for disease progression and survival.
- Being tested
- YKST02
- Keywords
- Relapsed or Refractory Multiple Myeloma, Bispecific Antibodies, YKST02, BCMA, CD3
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YKST02Drug
Participants will receive YKST02 by intravenous infusion according to the protocol-defined treatment schedule. Treatment will continue until a protocol-defined treatment discontinuation criterion is met.
| Study group | Role | What they receive |
|---|---|---|
| YKST02 | Experimental | Not described Receives: Drug: YKST02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Overall response rate (ORR), defined as the proportion of participants achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the investigator according to the 2016 International Myeloma Working Group (IMWG) response criteria.
Measured: From first dose until disease progression or initiation of subsequent anti-cancer therapy, whichever occurs first (up to approximately 2 years).
Secondary outcomes (15)
Time to Response (TTR)
Time from the first dose of YKST02 to the first documented objective response (partial response or better) according to the 2016 International Myeloma Working Group (IMWG) response criteria.
Measured: From first dose until first documented response (up to approximately 2 years)
Progression-Free Survival (PFS)
Time from the date of the first dose of YKST02 to the first documented disease progression or death from any cause, whichever occurs first, according to the 2016 IMWG response criteria.
Measured: From first dose until disease progression, death, or end of study (up to approximately 2 years)
Duration of Response (DOR)
Time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first, according to the 2016 IMWG response criteria.
Measured: From first documented response until disease progression, death, or end of study (up to approximately 2 years)
Overall Survival (OS)
Time from the date of the first dose of YKST02 to death from any cause. Participants without documented death will be censored at the earlier of the last date known to be alive or the study cutoff date.
Measured: From the date of first dose until death from any cause or study completion
Minimal Residual Disease (MRD) Negativity Rate
Proportion of participants who achieve minimal residual disease (MRD) negativity. MRD assessment will be performed in participants who achieve complete response (CR) or better.
Measured: From first dose through 28 days after the last dose (up to approximately 2 years)
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a participant administered the investigational product. An AE may be manifested as a sign, symptom, disease, or abnormal laboratory finding and does not necessarily have a causal relationship with the investigational product.
Measured: From the first dose through 28 days after the last dose (up to approximately 2 years).
Number of Participants with Serious Adverse Events (SAEs)
A serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is considered an important medical event.
Measured: From the first dose through 28 days after the last dose (up to approximately 2 years).
Number of Participants with Clinically Significant Laboratory Abnormalities
Number of participants with treatment-emergent clinically significant laboratory abnormalities, as assessed by the investigator.
Measured: From first dose through 28 days after the last dose (up to approximately 2 years)
Eastern Cooperative Oncology Group (ECOG) performance status
Changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status, assessed using the ECOG Performance Status scale (scores range from 0 to 5, with lower scores indicating better functional status).
Measured: From first dose through 28 days after the last dose (up to approximately 2 years)
Incidence of Anti-drug Antibodies (ADA)
Proportion of participants who develop anti-drug antibodies (ADA) following administration of YKST02.
Measured: From first dose through 28 days after the last dose (up to approximately 2 years)
Incidence of Neutralizing Antibodies (NAb)
Proportion of ADA-positive participants who develop neutralizing antibodies (NAb).
Measured: From first dose through 28 days after the last dose (up to approximately 2 years)
Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of YKST02.
Measured: From first dose through end of PK sampling (up to approximately 2 years)
Maximum Observed Serum Concentration (Cmax)
Maximum observed serum concentration (Cmax) of YKST02 following study drug administration.
Measured: From first dose through end of PK sampling (up to approximately 2 years)
Time to Maximum Serum Concentration (Tmax)
Time to maximum observed serum concentration (Tmax) of YKST02 following study drug administration.
Measured: From first dose through end of PK sampling (up to approximately 2 years)
Terminal Elimination Half-life (t½)
Terminal elimination half-life (t½) of YKST02 estimated using noncompartmental pharmacokinetic analysis.
Measured: From first dose through end of PK sampling (up to approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple Myeloma (RRMM)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Excyte Biopharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695740
- Sponsor's protocol ID
- YKST02-Ⅱ-01
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07695740
- Acronym / sponsor ID
- YKST02-Ⅱ-01
- Keywords
- Relapsed or Refractory Multiple Myeloma, Bispecific Antibodies, YKST02, BCMA, CD3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Excyte Biopharma LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 10 Jul 2026 (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.
The goal of this Phase 2 clinical trial is to learn whether YKST02 is effective and safe in adults with relapsed or refractory multiple myeloma. The study will also evaluate how YKST02 is processed by the body (pharmacokinetics), how it affects the body (pharmacodynamics), and whether it causes the body to produce anti-drug antibodies.
The main questions it aims to answer are:
Does YKST02 demonstrate clinical efficacy in adults with relapsed or refractory multiple myeloma? What side effects occur during treatment with YKST02? What are the pharmacokinetic, pharmacodynamic, and immunogenicity characteristics of YKST02?
Participants will:
Complete screening assessments to determine whether they are eligible for the study.
Receive YKST02 by intravenous infusion according to the study treatment schedule.
Undergo regular assessments to evaluate treatment response and monitor safety. Provide blood and urine samples for pharmacokinetic, pharmacodynamic, and immunogenicity testing.
Complete follow-up visits after treatment discontinuation to monitor disease progression and survival.
Multiple myeloma is a cancer of plasma cells that remains incurable despite advances in treatment. Although currently available therapies can improve outcomes, most patients eventually experience disease relapse or become refractory to treatment.
YKST02 is an investigational humanized bispecific antibody targeting BCMA on myeloma cells and CD3 on T cells. Simultaneous binding to BCMA and CD3 may activate T cells and promote tumor cell killing.
This is a multicenter, open-label study consisting of two parts (Phase IIa and Phase IIb). In Phase IIa, participants will initially receive YKST02 at the starting dose level. Safety and efficacy data from this part of the study will be reviewed to determine the dose to be evaluated in Phase IIb.
Detailed description
Relapsed or refractory multiple myeloma (RRMM) remains an incurable plasma cell malignancy despite substantial advances in treatment. Although currently available therapies, including proteasome inhibitors, immunomodulatory agents, anti-CD38 monoclonal antibodies, autologous stem cell transplantation, and B-cell maturation antigen (BCMA)-targeted therapies, have improved clinical outcomes, most patients eventually experience disease progression or relapse. Therefore, additional treatment options remain needed.
BCMA is highly expressed on malignant plasma cells and has emerged as an important therapeutic target for multiple myeloma.
YKST02 is an investigational humanized bispecific antibody targeting BCMA on myeloma cells and CD3 on T cells. Through simultaneous binding to BCMA and CD3, YKST02 is intended to redirect T cells to BCMA-expressing tumor cells, resulting in T-cell activation and tumor cell killing.
This is a multicenter, open-label, Phase 2 study designed to evaluate the efficacy, safety, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of YKST02 in adults with relapsed or refractory multiple myeloma.
Approximately 39 to 64 participants will be enrolled across multiple study centers in China, depending on the number of dose cohorts evaluated in Phase IIa.
The study consists of two parts. Phase IIa is designed to evaluate the safety and efficacy of YKST02 and to support selection of the dose for further evaluation in Phase IIb. Phase IIb will further evaluate the efficacy, safety, pharmacokinetics, immunogenicity, and pharmacodynamics of YKST02 at the selected dose.
Participants who meet all eligibility criteria will receive YKST02 according to the protocol-defined treatment schedule and undergo regular efficacy and safety assessments throughout the study. Blood and urine samples will be collected for pharmacokinetic, pharmacodynamic, and immunogenicity evaluations.
Participants will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, completion of the protocol-defined treatment period, or another protocol-defined discontinuation criterion. After treatment discontinuation, participants will enter follow-up for disease progression and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YKST02 | Experimental | Drug: YKST02 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able and willing to provide written informed consent (or consent provided by a legally authorized representative, where applicable) and comply with all study procedures.
- Diagnosis of multiple myeloma according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria.
- Relapsed or refractory multiple myeloma after at least two prior lines of therapy, including prior exposure to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
- Measurable disease as defined in the study protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (17 listed)
- Plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary light-chain (AL) amyloidosis.
- Prior treatment with any BCMA-targeted therapy, including BCMA-directed chimeric antigen receptor (CAR) T-cell therapy.
- Recent anticancer therapy, investigational medicinal product, radiotherapy, stem cell transplantation, or organ transplantation that does not meet the protocol-defined washout requirements.
- Active graft-versus-host disease (GvHD) requiring systemic treatment or clinically significant active GvHD.
- History of another malignancy within the past 5 years, except for adequately treated malignancies with negligible risk of recurrence, as specified in the protocol.
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 |
|---|---|---|
| YKST02Participants will receive YKST02 by intravenous infusion according to the protocol-defined treatment schedule. Treatment will continue until a protocol-defined treatment discontinuation criterion is met. | Drug | YKST02 |
Primary outcome
Overall Response Rate (ORR)
Time frame: From first dose until disease progression or initiation of subsequent anti-cancer therapy, whichever occurs first (up to approximately 2 years).
Overall response rate (ORR), defined as the proportion of participants achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the investigator according to the 2016 International Myeloma Working Group (IMWG) response criteria.
15 secondary outcomes
Time to Response (TTR)
Time frame: From first dose until first documented response (up to approximately 2 years)
Progression-Free Survival (PFS)
Time frame: From first dose until disease progression, death, or end of study (up to approximately 2 years)
Duration of Response (DOR)
Time frame: From first documented response until disease progression, death, or end of study (up to approximately 2 years)
Overall Survival (OS)
Time frame: From the date of first dose until death from any cause or study completion
Minimal Residual Disease (MRD) Negativity Rate
Time frame: From first dose through 28 days after the last dose (up to approximately 2 years)
Number of Participants with Adverse Events (AEs)
Time frame: From the first dose through 28 days after the last dose (up to approximately 2 years).
Number of Participants with Serious Adverse Events (SAEs)
Time frame: From the first dose through 28 days after the last dose (up to approximately 2 years).
Number of Participants with Clinically Significant Laboratory Abnormalities
Time frame: From first dose through 28 days after the last dose (up to approximately 2 years)
Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: From first dose through 28 days after the last dose (up to approximately 2 years)
Incidence of Anti-drug Antibodies (ADA)
Time frame: From first dose through 28 days after the last dose (up to approximately 2 years)
Incidence of Neutralizing Antibodies (NAb)
Time frame: From first dose through 28 days after the last dose (up to approximately 2 years)
Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
Time frame: From first dose through end of PK sampling (up to approximately 2 years)
Maximum Observed Serum Concentration (Cmax)
Time frame: From first dose through end of PK sampling (up to approximately 2 years)
Time to Maximum Serum Concentration (Tmax)
Time frame: From first dose through end of PK sampling (up to approximately 2 years)
Terminal Elimination Half-life (t½)
Time frame: From first dose through end of PK sampling (up to approximately 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YKST02 in people with Relapsed or Refractory Multiple Myeloma (RRMM), run by Excyte Biopharma 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 10 inclusion and 17 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: opening soon, as of the sponsor's last update on 10 Jul 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenming Chen, MD (+86-13910107759, 13910107759@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: From first dose until disease progression or initiation of subsequent anti-cancer therapy, whichever occurs first (up to approximately 2 years).). 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 10 Jul 2026.