Advanced Malignant TumorsSYH2095-001NCT07692776
SYH2095 for Advanced Malignant Tumors: Phase I Study
An observational study of Advanced Malignant Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, multicenter Phase 1 first-in-human trial of SYH2095, a selective KAT6A/B inhibitor. The trail contains two segments: Part 1A dose escalation and Part 2A cohort expansion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- SYH2095
- Type of treatment
- Pill or oral medicine
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to 1 Jun 2029
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population: Patients diagnosed with malignant tumors for whom no established standard therapeutic regimen is available.
Who may be able to join
- Fully understand this clinical trial, and voluntarily sign a written informed consent form (ICF);
- Age ≥ 18 years (at the time of informed consent), male or female;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1;
- Estimated life expectancy ≥ 3 months;
- At least one measurable or evaluable tumor lesion at baseline per RECIST V1.1;
- For advanced HR+/HER2- breast cancer, the following requirements must be met:
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- HR positive is defined as: ER positive and/or PR positive, confirmed by tumor biopsy (biopsy method comply with local diagnosis and treatment standards) that the tumor tissue is ER/PR positive, and the proportion of positive staining cells among all tumor cells is ≥1%;
- HER2 negative is defined based on American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as: immunohistochemistry score of 0/1+, or a negative result determined by in situ hybridization (HER2/CEP17 ratio <2.0, or HER2 gene copy number <4.0 using a single probe);
- Participants need to be postmenopausal. Female participants with childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause by treatment with the approved LHRH agonist such as goserelin, leuprolide, or an equivalent to induce chemical menopause.7.Participants with childbearing potential (male or female) must agree to use a reliable contraceptive method (see Appendix 13.1) with their partner during trial and for at least 13 weeks (males) or 25 weeks (females) after the last dose. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose;
- 8.Participants must meet the following laboratory tests requirements (all test results must be completed within 7 days before the first dose without corrective interventions such as transfusion, hematopoietic growth factors, etc., or stable for more than 7 days after treatment)
Who cannot join
- Presence of known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis. Participants with prior locoregional treatment for brain metastases may be enrolled only if medically stable for ≥ 4 weeks prior to the first dose. Medically stable is defined as the following conditions: no clinical symptoms attributable to CNS metastases within 4 weeks prior to the first dose (e.g., progressive or new neurological deficit, epileptic seizure, increased intracranial pressure, vomiting, papilledema, or headache); no evidence of CNS neoplasm relapse/progression on imaging assessments within 4 weeks prior to the first dose; no glucocorticoid therapy (>10 mg/day prednisone or equivalent) for ≥4 weeks prior to the first dose;
- Participants with uncontrolled third interstitial effusions (e.g., pericardial effusion, pleural effusion, ascites) that cannot be controlled by repeated drainage or other interventions, and who are not suitable for enrollment by the investigator;
- Participants with history of severe cardiovascular disease within 6 months prior to the first dose, including any of the following: (1) Congestive heart failure (New York Heart Association (NYHA) class > grade Ⅱ); (2) Severe/unstable angina, or new-onset angina pectoris within 3 months before the first dose; (3) Participants with myocardial ischaemia requiring long-term pharmacologic control, or heart failure (NYHA class Ⅲ-Ⅳ); (4) History of acute myocardial infarction; (5) Any grade ≥2 supraventricular or ventricular arrhythmia requiring treatment or intervention; (6) History of atrial fibrillation, coronary/peripheral artery bypass grafting, or transient ischaemic attack (TIA) with cerebrovascular symptoms; (7) Uncontrolled hypertension at screening (despite pharmacotherapy: diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg);(8) QTcF≥ 470 ms on 12-lead (ECGs) performed in triplicate;
- Participants with factors affecting oral administration (e.g., dysphagia, intestinal obstruction); or active gastrointestinal diseases or other conditions that may significantly alter drug absorption, distribution, metabolism, or excretion (including active inflammatory bowel disease, chronic diarrhea, frequent vomiting, enterocolitis, etc.);
- Participants with active autoimmune disease, a history of immunodeficiency or autoimmune disease, or a history of non-active autoimmune disease requiring long-term treatment with systemic corticosteroids or immunosuppressants agents, or with conditions associated with immunodeficiency (including HIV, congenital immunodeficiency diseases, etc.), or a history of organ transplantation (including allogeneic bone marrow transplantation);
- Drug-induced pneumonia, interstitial lung disease (ILD), or immune-mediated pneumonitis; or a history of active radiation pneumonitis requiring steroid therapy, or other severe lung dysfunction diseases, symptoms or signs at screening (e.g., severe chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, etc.);
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- Presence of active hepatitis B, active hepatitis C, active tuberculosis, or active syphilis infection, including:
- Active hepatitis B: HBsAg positive and HBV-DNA quantitative titer test ≥20 IU/mL or HBV-DNA ≥102; B. Active Hepatitis C: anti-HCV positive and HCV-RNA positive; C. Active tuberculosis: history of tuberculosis treatment within 2 years prior to the first dose; D. Active syphilis: presence of syphilis infection requiring systemic therapy;
- Participants with a diagnosis of other malignant tumor within the past 5 years (except those with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma, or carcinoma in situ [e.g., cervical carcinoma in situ, breast ductal carcinoma in situ] that have received radical treatment);
- Use of strong/moderate inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose;
- Use of proton pump inhibitors (PPIs) within 2 weeks prior to the first dose;
- History of nervous system or psychiatric disorders, history of psychotropic drug abuse, or drug addiction ; alcohol or drug abuse/dependence, which may interfere with the administration of the investigational product, affect the assessment and judgment of investigational product's toxicity and AEs, or result in inadequate or decreased trial compliance; participants with other severe physical or laboratory abnormalities that, in the investigator's judgment, may increase the risk to the participant or interfere with the clinical trial results, and are thus considered unsuitable for trial participation;
- Received any anti-tumor therapy or enrolled in other interventional clinical trial within 4 weeks prior to the first dose, including cytotoxic drugs, endocrine therapy, immunotherapy, targeted therapy, surgery (except puncture biopsy, peripherally inserted central catheterisation or infusion port catheterization) or other clinical trial investigational products; or received radiotherapy within 2 weeks prior to the first dose;
- Previous anti-tumor therapy-related toxicity that has not recovered to CTCAE version 6.0 grade ≤1 (except toxicities determined by the investigator to post no safety risk, e.g., alopecia, fatigue, isolated laboratory abnormalities, peripheral neuropathy, etc.);
- Previous participation in any clinical trial involving a KAT6A/B or KAT7 inhibitor;
- Hypersensitivity to any investigational product or its excipients in this clinical trial;
- Female participants who are pregnant, breastfeeding, or planning a pregnancy during the trial;
- Participants with active infection requiring treatment with antibiotics, antivirals or antifungals, or unexplained fever >38.5℃ within 2 weeks prior to the first dose (except tumor-related fever as determined by the investigator);
- Participants with hemorrhagic events within 4 weeks prior to the first dose (e.g., active gastrointestinal bleeding, gross hematuria, haemoptysis, etc.);
- Presence of severe bone injury due to bone metastases, as determined by the investigator, including uncontrolled severe bone pain, pathological fractures at critical sites, or spinal cord compression that occurred within 6 months prior to the first dose or is expected to occur in the near future;
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
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjing, 300060
Yehui Shi, PhD, shiyehui@tjmuch.com
About this study
Official title: An Open-Label, Multi-Center Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYH2095 in Advanced Malignant Tumors
This is an open-label, multicenter Phase 1 first-in-human trial of SYH2095, a selective KAT6A/B inhibitor. The trail contains two segments: Part 1A dose escalation and Part 2A cohort expansion. Part 1A uses the BOIN dose-escalation design, enrolling patients with advanced malignant tumors with no effective standard treatment. Its primary goals are to assess safety and tolerability, define dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), and establish the recommended expansion dose (RDE). Part 2A is an expansion cohort using the RDE identified in Part 1A,. All participants receive oral SYH2095 once daily in 4-week treatment cycles. Safety evaluations, tumor imaging, pharmacokinetic (PK), pharmacodynamic (PD) and biomarker analyses will be performed at scheduled time points throughout treatment.
- Conditions
- Advanced Malignant Tumors
- Being tested
- SYH2095
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2095Drug
Selective KAT6A/B inhibitor, oral tablet.. Administered orally once daily on an empty stomach, 4 weeks per treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| SYH2095 Monotherapy Dose Escalation Cohort (1A) | This arm adopts sequential ascending dose cohorts for dose-escalation evaluation, and enrolls participants with malignancies. Receives: Drug: SYH2095 | |
| SYH2095 Monotherapy Expansion Cohort (2A) | SYH2095 at RDE (QD, oral), Enroll treated malignant tumors. Receives: Drug: SYH2095 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicity
Proportion of participants with DLT during the first 28-day treatment cycle (DLT observation period), assessed per NCI-CTCAE 6.0.
Measured: End of Part 1 Dose Escalation and Backfill phase (each cycle is 28 days; all safety data collected through Day 28 of Cycle 1 for every dose-escalation subject)]
Maximum Tolerated Dose (MTD) of SYH2095
Determine the MTD of SYH2095 for monotherapy based on DLT and overall safety data.
Measured: End of Part 1 Dose Escalation and Backfill phase (each cycle is 28 days; all safety data collected through Day 28 of Cycle 1 for every dose-escalation subject)]
Maximum Tolerated Dose of SYH2095
Description: Determine the MTD of SYH2095 for monotherapy based on DLT and overall safety data
Measured: End of Part 1 Dose Escalation phase (each cycle is 28 days; safety data collected through Day 28 of Cycle 1 for all dose-escalation subjects)]
Objective Response Rate
Confirmed ORR assessed by investigators per RECIST 1.1 in cohort expansion participants.
Measured: 2 years
Phase 2 Recommended Dose of SYH2095
Determine RP2D for monotherapy based on safety, PK and efficacy data.
Measured: 2 years
Overall Safety Profile
Incidence, severity and causality of adverse event
Measured: From informed consent to 28 days after last study drug administration
Maximum Observed Concentration (Cmax)
Pharmacokinetic (PK) assessments for SYH2095 Part 1A and Part 2A
Measured: 2 years
Secondary outcomes (11)
Time to Maximum concentration (Tmax)
Pharmacokinetic (PK) assessments for SYH2095 Part 1A and Part 2A
Measured: 2 years
AUC from time zero to time of last measurable concentration (AUClast)
Pharmacokinetic (PK) assessments for SYH2095 Part 1A and Part 2A
Measured: 2 years
Terminal Elimination half-life (t1/2)
Pharmacokinetic (PK) assessments for SYH2095 Part 1A and Part 2A
Measured: 2 years
Steady-State Cmax
Pharmacokinetic (PK) assessments for SYH2095 Part 1A and Part 2A
Measured: 2 years
Steady-state Tmax (Tmax,ss)
Pharmacokinetic (PK) assessments for SYH2095 Part 1A and Part 2A
Measured: 2 years
Steady state AUC during a dosage interval (τ) (AUCτ,ss)
Pharmacokinetic (PK) assessments for SYH2095 Part 1A and Part 2A
Measured: 2 years
Steady-state apparent total clearance (CLss/F)
Pharmacokinetic (PK) assessments for SYH2095 Part 1A and Part 2A
Measured: 2 years
Progression Free Survival (PFS)
Progression Free Survival (PFS)
Measured: 2 years
Overall survival (OS)
Overall survival (OS)
Measured: 2 years
Duration of Response (DOR)
Duration of Response (DOR)
Measured: 2 years
Disease Control Rate (DCR)
Disease Control Rate (DCR)
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startJul 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorsStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hangzhou Innogate Pharma Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692776
- Sponsor's protocol ID
- SYH2095-001
- Acronym
- SYH2095-001
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYH2095 in Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT07692776
- Acronym / sponsor ID
- SYH2095-001 / SYH2095-001
- Conditions
- Advanced Malignant Tumors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hangzhou Innogate Pharma Co., Ltd
- Study start
- Jul 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 9 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.
This is an open-label, multicenter Phase 1 first-in-human trial of SYH2095, a selective KAT6A/B inhibitor. The trail contains two segments: Part 1A dose escalation and Part 2A cohort expansion. Part 1A uses the BOIN dose-escalation design, enrolling patients with advanced malignant tumors with no effective standard treatment. Its primary goals are to assess safety and tolerability, define dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), and establish the recommended expansion dose (RDE). Part 2A is an expansion cohort using the RDE identified in Part 1A,. All participants receive oral SYH2095 once daily in 4-week treatment cycles. Safety evaluations, tumor imaging, pharmacokinetic (PK), pharmacodynamic (PD) and biomarker analyses will be performed at scheduled time points throughout treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYH2095 Monotherapy Dose Escalation Cohort (1A) | – | Drug: SYH2095This arm adopts sequential ascending dose cohorts for dose-escalation evaluation, and enrolls participants with malignancies. |
| SYH2095 Monotherapy Expansion Cohort (2A) | – | Drug: SYH2095SYH2095 at RDE (QD, oral), Enroll treated malignant tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population: Patients diagnosed with malignant tumors for whom no established standard therapeutic regimen is available.
Key inclusion criteria (10 listed)
- Fully understand this clinical trial, and voluntarily sign a written informed consent form (ICF);
- Age ≥ 18 years (at the time of informed consent), male or female;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1;
- Estimated life expectancy ≥ 3 months;
- At least one measurable or evaluable tumor lesion at baseline per RECIST V1.1;
Key exclusion criteria (20 listed)
- Presence of known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis. Participants with prior locoregional treatment for brain metastases may be enrolled only if medically stable for ≥ 4 weeks prior to the first dose. Medically stable is defined as the following conditions: no clinical symptoms attributable to CNS metastases within 4 weeks prior to the first dose (e.g., progressive or new neurological deficit, epileptic seizure, increased intracranial pressure, vomiting, papilledema, or headache); no evidence of CNS neoplasm relapse/progression on imaging assessments within 4 weeks prior to the first dose; no glucocorticoid therapy (>10 mg/day prednisone or equivalent) for ≥4 weeks prior to the first dose;
- Participants with uncontrolled third interstitial effusions (e.g., pericardial effusion, pleural effusion, ascites) that cannot be controlled by repeated drainage or other interventions, and who are not suitable for enrollment by the investigator;
- Participants with history of severe cardiovascular disease within 6 months prior to the first dose, including any of the following: (1) Congestive heart failure (New York Heart Association (NYHA) class > grade Ⅱ); (2) Severe/unstable angina, or new-onset angina pectoris within 3 months before the first dose; (3) Participants with myocardial ischaemia requiring long-term pharmacologic control, or heart failure (NYHA class Ⅲ-Ⅳ); (4) History of acute myocardial infarction; (5) Any grade ≥2 supraventricular or ventricular arrhythmia requiring treatment or intervention; (6) History of atrial fibrillation, coronary/peripheral artery bypass grafting, or transient ischaemic attack (TIA) with cerebrovascular symptoms; (7) Uncontrolled hypertension at screening (despite pharmacotherapy: diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg);(8) QTcF≥ 470 ms on 12-lead (ECGs) performed in triplicate;
- Participants with factors affecting oral administration (e.g., dysphagia, intestinal obstruction); or active gastrointestinal diseases or other conditions that may significantly alter drug absorption, distribution, metabolism, or excretion (including active inflammatory bowel disease, chronic diarrhea, frequent vomiting, enterocolitis, etc.);
- Participants with active autoimmune disease, a history of immunodeficiency or autoimmune disease, or a history of non-active autoimmune disease requiring long-term treatment with systemic corticosteroids or immunosuppressants agents, or with conditions associated with immunodeficiency (including HIV, congenital immunodeficiency diseases, etc.), or a history of organ transplantation (including allogeneic bone marrow transplantation);
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 |
|---|---|---|
| SYH2095Selective KAT6A/B inhibitor, oral tablet.. Administered orally once daily on an empty stomach, 4 weeks per treatment cycle. | Drug | SYH2095 Monotherapy Dose Escalation Cohort (1A), SYH2095 Monotherapy Expansion Cohort (2A) |
Primary outcome
Incidence of Dose-Limiting Toxicity
Time frame: End of Part 1 Dose Escalation and Backfill phase (each cycle is 28 days; all safety data collected through Day 28 of Cycle 1 for every dose-escalation subject)]
Proportion of participants with DLT during the first 28-day treatment cycle (DLT observation period), assessed per NCI-CTCAE 6.0.
Maximum Tolerated Dose (MTD) of SYH2095
Time frame: End of Part 1 Dose Escalation and Backfill phase (each cycle is 28 days; all safety data collected through Day 28 of Cycle 1 for every dose-escalation subject)]
Determine the MTD of SYH2095 for monotherapy based on DLT and overall safety data.
Maximum Tolerated Dose of SYH2095
Time frame: End of Part 1 Dose Escalation phase (each cycle is 28 days; safety data collected through Day 28 of Cycle 1 for all dose-escalation subjects)]
Description: Determine the MTD of SYH2095 for monotherapy based on DLT and overall safety data
Objective Response Rate
Time frame: 2 years
Confirmed ORR assessed by investigators per RECIST 1.1 in cohort expansion participants.
Phase 2 Recommended Dose of SYH2095
Time frame: 2 years
Determine RP2D for monotherapy based on safety, PK and efficacy data.
Overall Safety Profile
Time frame: From informed consent to 28 days after last study drug administration
Incidence, severity and causality of adverse event
Maximum Observed Concentration (Cmax)
Time frame: 2 years
Pharmacokinetic (PK) assessments for SYH2095 Part 1A and Part 2A
11 secondary outcomes
Time to Maximum concentration (Tmax)
Time frame: 2 years
AUC from time zero to time of last measurable concentration (AUClast)
Time frame: 2 years
Terminal Elimination half-life (t1/2)
Time frame: 2 years
Steady-State Cmax
Time frame: 2 years
Steady-state Tmax (Tmax,ss)
Time frame: 2 years
Steady state AUC during a dosage interval (τ) (AUCτ,ss)
Time frame: 2 years
Steady-state apparent total clearance (CLss/F)
Time frame: 2 years
Progression Free Survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Duration of Response (DOR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2years
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 9 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?
An observational study of Advanced Malignant Tumors, run by CSPC ZhongQi Pharmaceutical Technology 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 10 inclusion and 20 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 9 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.
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 Clinical Trial Information Team Officer (+86-311 6908 5587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicity (time frame: End of Part 1 Dose Escalation and Backfill phase (each cycle is 28 days; all safety data collected through Day 28 of Cycle 1 for every dose-escalation subject)]). The study lists 7 primary outcomes in all. 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 9 Jul 2026.