Solid TumorPhase 1NCT04977167
Clinical Trial of HG146 Administered to Subjects With Advanced Solid Tumors or Lymphoma
A Phase 1 study testing HG146 and PD-(L)1 antibody in people with Solid Tumor and Lymphoma, run by HitGen Inc. at 1 site in China.
Trial summary
This is a Phase I, open-label, repeat-dose, non-randomized, multicenter study to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of HG146 administered orally (PO) alone (Part 1) or co-administered (Part 2) with PD-（L）1 inhibitor in subjects with refractory/relapsed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Lymphoma
- What is being tested?
- HG146 and PD-(L)1 antibody
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2021to 22 Dec 2024
- 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
- 1 Subject must be >=18 years of age at the time of signing the informed consent.
- 2- Ia/Ib dose escalation phase（Part1 and Part 2A）：Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.
- Ib dose expansion phase（Part 2）:
- Cohort 1,Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established, have not been treated with PD-(L)1 antibody； 2）Cohort 2,Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established, have progressed on PD-(L)1 antibody； 3 Measurable disease per RECIST version 1.1 or Lugano 2014（If applicable）. 4 Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1. 5 Has adequate organ function. 6 Signed informed consent form (ICF) and able to comply with study requirements.
Who cannot join
- Received prior therapies targeting HDAC.
- Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment.
- History of intolerant of anti-PD-(L)1 toxicity（Ib）.
- A condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of enrollment.
- Major surgery or major injury <=28 days before the first dose of study treatment,or anticipated major surgery during the study.
- Received other anticaner therapies within 4 weeks prior to first dose of study treatment or 5 half life period of anticancer drug .
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- Active infection requiring systemic treatment.
- Prior allogeneic bone marrow transplantation or other solid organ transplantation ( Ib)
- Active autoimmune disease or disease of impaired immune system(Ib).
- History of Adrenal insufficiency.(Ib)
- History orConcurrent condition of other malignant tumors.
- Recent (within the past 6 months) history of Unstable or serious diseases, such as pancreatitis, severe angina, prolonged QT interval, congestive heart failure, myocardial infarction, pulmonary hypertension, stroke, and severe seizures, etc.
- History of severe lung disease.
- Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Open Label Study of HG146 Alone /in Combination With PD-(L)1 Inhibitor Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors or Lymphoma
This is a Phase I, open-label, repeat-dose, non-randomized, multicenter study to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of HG146 administered orally (PO) alone (Part 1) or co-administered (Part 2) with PD-（L）1 inhibitor in subjects with refractory/relapsed solid tumors or Lymphoma. Part 1 consists of a dose escalation phae,Part2 consists of a dose escalation phase and a cohort expansion phase. In Part 1, escalating doses of HG146 will be evaluated as guided by the "3+3" approach. In Part 2A, escalating doses of HG146 in combination with PD-(L)1 inhibitor will be evaluated as guided by the "3+3" approach. In Part 2B, subjects will receive a single dose level of HG146 as identified based on data from Part 2, in combination with PD-(L)1 inhibitor . A total of approximately 96 subjects will be enrolled in this study, approximately 36 for dose escalation cohorts, and approximately 60 in the expansion cohorts.
- Conditions
- Solid Tumor, Lymphoma
- Being tested
- HG146, PD-(L)1 antibody
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HG146Drug
Also called HG146 capsule
HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.
PD-(L)1 antibodyDrug
Also called PD-1 antibody
PD-(L)1 Antibody is available as solution for infusion or lyophilized powder for reconstitution to be administered Q3W. It will be administered as an IV infusion for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Part 1:HG146 Monotherapy, Dose-escalation Cohort | Experimental | Subjects will receive HG146 PO at every two days intervals (qod) for 14 consecutive days,7 days off, 21 days/ cycle. Escalating doses of HG146 will be evaluated using 3+3 approach. Receives: Drug: HG146 |
| Part 2A:HG146 + PD-(L)1 antibody, Dose escalation Cohort | Experimental | Subjects will receive HG146 PO at every two days intervals (qod) for 14 consecutive days,7 days off, along with PD-(L)1 antibody IV once every 3 weeks (Q3W),21 days/ cycle.
Escalating doses of HG146 in combination with PD-(L)1 antibody will be evaluated. Receives: Drug: HG146; Drug: PD-(L)1 antibody |
| Part 2B-1：HG146 combination Expansion Cohort 1 | Experimental | Subjects who have not been treated with PD-(L)1 antibody，will receive HG146 po for 14 consecutive days,7 days off, in combination with PD-(L)1 antibody IV Q3W. Receives: Drug: HG146; Drug: PD-(L)1 antibody |
| Part 2B-2：HG146 combination Expansion Cohort 2 | Experimental | Subjects who have progressed on PD-(L)1 antibody, will receive HG146 po for 14 consecutive days,7 days off, in combination with PD-(L)1 antibody IV Q3W. Receives: Drug: HG146; Drug: PD-(L)1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I：Dose-Limiting Toxicities (DLTs)
Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0)
Measured: Up to 26 Days in Cycle 0 and Cycle 1
Part I：Serious Adverse Events (SAEs) and Adverse Events (AE)
Number of participants experiencing Serious Adverse Events (SAEs) and Adverse Events (AE) According to Safety performance.
Measured: Up to 2 years
Part I：Maximum tolerated dose or Recommended Phase Ib dose (RP2D) of HG146
Maximum tolerated dose or Recommended Phase II dose of HG146 will be decided according to safety and effective results.
Measured: Up to 2 years
Part 2A: Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)
Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0)
Measured: Up to 21 Days in Cycle 1
Part 2A: Serious Adverse Events (SAEs) and Adverse Events (AE)
Number of participants experiencing Serious Adverse Events (SAEs) and Adverse Events (AE) According to Safety performance.
Measured: Up to 2 years
Part 2A:Maximum tolerated dose or Recommended Phase II dose (RP2D) of HG146 in combination with PD-(L)1 antibody
Maximum tolerated dose or Recommended Phase II dose of HG146 will be decided according to safety and effective results.
Measured: Up to 2 years
Secondary outcomes (19)
Part 1:Area under the concentration versus time curve (AUC) of HG146
Plasma concentration of HG146 will be measured following single dose and multiple dose administration
Measured: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)
Part 1:Peak plasma concentration (Cmax) of HG146
Plasma concentration of HG146 will be measured following single dose and multiple dose administration
Measured: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)
Part 1:Time of Cmax (Tmax) of HG146
Plasma concentration of HG146 will be measured following single dose and multiple dose administration
Measured: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15(Except for cycle 0, each cycle is 21 days)
Part 1:Apparent terminal half-life (T1/2) of HG146
Plasma concentration of HG146 will be measured following single dose and multiple dose administration
Measured: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)
Part1: objective response rate (ORR)
ORR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Measured: Up to 2 years
Part1: Best overall response (BOR)
BOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Measured: Up to 2 years
Part1: Duration of response (DOR)
DOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Measured: Up to 2 years
Part 1:Time-to-response (TTR)
TTR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Measured: Up to 2 years
Part 1:Progression-Free Survival (PFS)
PFS will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Measured: Up to 2 years
Part 2:Area under the concentration versus time curve (AUC) of HG146
Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
Measured: At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part 2:maximum observed plasma concentration (Cmax) of HG146
Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
Measured: At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part 2:time of maximum observed plasma concentration (Tmax) of HG146
Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
Measured: At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part 2:apparent terminal half-life (T1/2) of HG146
Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
Measured: At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part2: objective response rate (ORR)
ORR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Measured: Up to 2 years
Part2: Best overall response (BOR)
BOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Measured: Up to 2 years
Part2: Duration of response (DOR)
DOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Measured: Up to 2 years
Part 2:Time-to-response (TTR)
TTR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Measured: Up to 2 years
Part 2:Progression-Free Survival (PFS)
PFS will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Measured: Up to 2 years
Overall survival (OS)
OS will be assessed by the investigators
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start23 Sep 2021
- Primary completion13 Jun 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- HitGen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Principal investigator, National Cancer Center/Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977167
- Sponsor's protocol ID
- HG146CN102
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2021
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open Label Study of HG146 Alone /in Combination With PD-(L)1 Inhibitor Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT04977167
- Acronym / sponsor ID
- HG146CN102
- Conditions
- Solid Tumor, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- HitGen Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 26 Jul 2021 (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, open-label, repeat-dose, non-randomized, multicenter study to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of HG146 administered orally (PO) alone (Part 1) or co-administered (Part 2) with PD-（L）1 inhibitor in subjects with refractory/relapsed solid tumors or Lymphoma. Part 1 consists of a dose escalation phae,Part2 consists of a dose escalation phase and a cohort expansion phase. In Part 1, escalating doses of HG146 will be evaluated as guided by the "3+3" approach. In Part 2A, escalating doses of HG146 in combination with PD-(L)1 inhibitor will be evaluated as guided by the "3+3" approach. In Part 2B, subjects will receive a single dose level of HG146 as identified based on data from Part 2, in combination with PD-(L)1 inhibitor . A total of approximately 96 subjects will be enrolled in this study, approximately 36 for dose escalation cohorts, and approximately 60 in the expansion cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1:HG146 Monotherapy, Dose-escalation Cohort | Experimental | Drug: HG146Subjects will receive HG146 PO at every two days intervals (qod) for 14 consecutive days,7 days off, 21 days/ cycle. Escalating doses of HG146 will be evaluated using 3+3 approach. |
| Part 2A:HG146 + PD-(L)1 antibody, Dose escalation Cohort | Experimental | Drug: HG146, Drug: PD-(L)1 antibodySubjects will receive HG146 PO at every two days intervals (qod) for 14 consecutive days,7 days off, along with PD-(L)1 antibody IV once every 3 weeks (Q3W),21 days/ cycle. Escalating doses of HG146 in combination with PD-(L)1 antibody will be evaluated. |
| Part 2B-1：HG146 combination Expansion Cohort 1 | Experimental | Drug: HG146, Drug: PD-(L)1 antibodySubjects who have not been treated with PD-(L)1 antibody，will receive HG146 po for 14 consecutive days,7 days off, in combination with PD-(L)1 antibody IV Q3W. |
| Part 2B-2：HG146 combination Expansion Cohort 2 | Experimental | Drug: HG146, Drug: PD-(L)1 antibodySubjects who have progressed on PD-(L)1 antibody, will receive HG146 po for 14 consecutive days,7 days off, in combination with PD-(L)1 antibody IV Q3W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1 Subject must be >=18 years of age at the time of signing the informed consent.
- 2- Ia/Ib dose escalation phase（Part1 and Part 2A）：Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.
- Ib dose expansion phase（Part 2）:
Key exclusion criteria (14 listed)
- Received prior therapies targeting HDAC.
- Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment.
- History of intolerant of anti-PD-(L)1 toxicity（Ib）.
- A condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of enrollment.
- Major surgery or major injury <=28 days before the first dose of study treatment,or anticipated major surgery during the study.
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 |
|---|---|---|
| HG146Also: HG146 capsuleHG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg. | Drug | Part 1:HG146 Monotherapy, Dose-escalation Cohort, Part 2A:HG146 + PD-(L)1 antibody, Dose escalation Cohort, Part 2B-1：HG146 combination Expansion Cohort 1, Part 2B-2：HG146 combination Expansion Cohort 2 |
| PD-(L)1 antibodyAlso: PD-1 antibodyPD-(L)1 Antibody is available as solution for infusion or lyophilized powder for reconstitution to be administered Q3W. It will be administered as an IV infusion for 30 minutes. | Drug | Part 2A:HG146 + PD-(L)1 antibody, Dose escalation Cohort, Part 2B-1：HG146 combination Expansion Cohort 1, Part 2B-2：HG146 combination Expansion Cohort 2 |
Primary outcome
Part I：Dose-Limiting Toxicities (DLTs)
Time frame: Up to 26 Days in Cycle 0 and Cycle 1
Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0)
Part I：Serious Adverse Events (SAEs) and Adverse Events (AE)
Time frame: Up to 2 years
Number of participants experiencing Serious Adverse Events (SAEs) and Adverse Events (AE) According to Safety performance.
Part I：Maximum tolerated dose or Recommended Phase Ib dose (RP2D) of HG146
Time frame: Up to 2 years
Maximum tolerated dose or Recommended Phase II dose of HG146 will be decided according to safety and effective results.
Part 2A: Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)
Time frame: Up to 21 Days in Cycle 1
Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0)
Part 2A: Serious Adverse Events (SAEs) and Adverse Events (AE)
Time frame: Up to 2 years
Number of participants experiencing Serious Adverse Events (SAEs) and Adverse Events (AE) According to Safety performance.
Part 2A:Maximum tolerated dose or Recommended Phase II dose (RP2D) of HG146 in combination with PD-(L)1 antibody
Time frame: Up to 2 years
Maximum tolerated dose or Recommended Phase II dose of HG146 will be decided according to safety and effective results.
19 secondary outcomes
Part 1:Area under the concentration versus time curve (AUC) of HG146
Time frame: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)
Part 1:Peak plasma concentration (Cmax) of HG146
Time frame: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)
Part 1:Time of Cmax (Tmax) of HG146
Time frame: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15(Except for cycle 0, each cycle is 21 days)
Part 1:Apparent terminal half-life (T1/2) of HG146
Time frame: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)
Part1: objective response rate (ORR)
Time frame: Up to 2 years
Part1: Best overall response (BOR)
Time frame: Up to 2 years
Part1: Duration of response (DOR)
Time frame: Up to 2 years
Part 1:Time-to-response (TTR)
Time frame: Up to 2 years
Part 1:Progression-Free Survival (PFS)
Time frame: Up to 2 years
Part 2:Area under the concentration versus time curve (AUC) of HG146
Time frame: At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part 2:maximum observed plasma concentration (Cmax) of HG146
Time frame: At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part 2:time of maximum observed plasma concentration (Tmax) of HG146
Time frame: At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part 2:apparent terminal half-life (T1/2) of HG146
Time frame: At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part2: objective response rate (ORR)
Time frame: Up to 2 years
Part2: Best overall response (BOR)
Time frame: Up to 2 years
Part2: Duration of response (DOR)
Time frame: Up to 2 years
Part 2:Time-to-response (TTR)
Time frame: Up to 2 years
Part 2:Progression-Free Survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
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 21 Sep 2026.
- 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.
Yuankai Shi principal investigator
National Cancer Center/Cancer Hospital
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 HG146 and PD-(L)1 antibody in people with Solid Tumor and Lymphoma, run by HitGen Inc. 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 4 inclusion and 14 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 21 Sep 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 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?
Part I：Dose-Limiting Toxicities (DLTs) (time frame: Up to 26 Days in Cycle 0 and Cycle 1). The study lists 6 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 21 Sep 2026.