A Phase 1 interventional study of HG146 and PD-(L)1 antibody in Solid Tumor and Lymphoma, sponsored by HitGen Inc.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by HitGen Inc. · Phase 1, Interventional, and Treatment
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.
3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.
This study's enrollment of 24 is below the median of 43 across 2,319 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →HitGen Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
1 Subject must be >=18 years of age at the time of signing the .
2- Ia/Ib dose escalation phase（Part1 and Part 2A）：Subjects with advanced/ 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: HG146
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.
Drug: HG146 · Drug: PD-(L)1 antibody
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.
Drug: HG146 · Drug: PD-(L)1 antibody
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.
Drug: HG146 · Drug: PD-(L)1 antibody
HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.
Also known as: HG146 capsule
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.
Also known as: PD-1 antibody
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)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Up to 2 years
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
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
Plasma concentration of HG146 will be measured following single dose and multiple dose administration
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
Plasma concentration of HG146 will be measured following single dose and multiple dose administration
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
Plasma concentration of HG146 will be measured following single dose and multiple dose administration
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)
ORR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
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
Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
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
Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to 2 years
Overall survival (OS)
OS will be assessed by the investigators
Time frame: Up to 2 years
Plan to share: No
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Studies of the drug tested here: HDAC Class I/IIb Inhibitor HG146
HitGen Inc.