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CompletedNCT04977167Updated Sep 21, 2026

Clinical Trial of HG146 Administered to Subjects With Advanced Solid Tumors or Lymphoma

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

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Solid Tumor
  • Lymphoma

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

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）:

    1. 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.

Key Exclusion Criteria:

  1. Received prior therapies targeting HDAC.
  2. Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment.
  3. History of intolerant of anti-PD-(L)1 toxicity（Ib）.
  4. A condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of enrollment.
  5. Major surgery or major injury \<=28 days before the first dose of study treatment,or anticipated major surgery during the study.
  6. Received other anticaner therapies within 4 weeks prior to first dose of study treatment or 5 half life period of anticancer drug .
  7. Active infection requiring systemic treatment.
  8. Prior allogeneic bone marrow transplantation or other solid organ transplantation ( Ib)
  9. Active autoimmune disease or disease of impaired immune system(Ib).
  10. History of Adrenal insufficiency.(Ib)
  11. History orConcurrent condition of other malignant tumors.
  12. 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.
  13. History of severe lung disease.
  14. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Part 1:HG146 Monotherapy, Dose-escalation Cohort

    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

  • Experimental
    Part 2A:HG146 + PD-(L)1 antibody, Dose escalation Cohort

    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

  • Experimental
    Part 2B-1：HG146 combination Expansion Cohort 1

    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

  • Experimental
    Part 2B-2：HG146 combination Expansion Cohort 2

    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

Interventions

  • DrugHG146

    HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.

    Also known as: HG146 capsule

  • DrugPD-(L)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.

    Also known as: PD-1 antibody

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. Overall survival (OS)

    OS will be assessed by the investigators

    Time frame: Up to 2 years

06

Study locations

1 site
  • National Cancer Center/Cancer Hospital
    Beijing, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04977167
Lead sponsor
HitGen Inc.
Responsible party
Sponsor
First posted
Jul 26, 2021
Start date
Sep 23, 2021
Primary completion
Jun 13, 2024
Completion
Dec 22, 2024
Last update
Sep 21, 2026

Study contacts

Yuankai Shi
principal investigator · National Cancer Center/Cancer Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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