Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

All Drugs and Chemicals

Pharmaceutical Solutions

Antibodies

Immunoglobulins

Immunologic Factors

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.

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.

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.

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.

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

HG146

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.

PD-(L)1 antibody

Jie Shen

Yuankai Shi

Yu mei Che

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.

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

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

Plasma concentration of HG146 will be measured following single dose and multiple dose administration

ORR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

BOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

DOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

TTR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

PFS will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody

HitGen Inc.

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Histone Deacetylase Inhibitors

Experimental: 5/10/15/20 mg HG146 capsule 5 mg starting dose taken orally on Day 1, 3, 5, 7, 9, 11, 13 of each cycle, and off drug for 8 days (3 weeks).

Intervention: Drug: HG146 capsule

HG146 will be administered every other day for 14 days, followed by 1 week off the drug with each treatment cycle of 21-days.

Ting Liu, M.D.

This study is designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma.

This study is mainly designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma. Secondly, to get pharmacokinetic data and preliminary efficacy of HG146 capsule in human.

This study adopts the traditional design of "3 + 3" dose escalation. The starting dose is 5 mg and subsequent dose group is respectively for 10, 15 and 20 mg. For each dosing group, subjects are administered orally HG146 every other day for two weeks, followed by one week of rest with 21-day as one treatment cycle. Patients will be treated for 4 cycles or disease progression or unacceptable toxicities, whichever comes first.

Drug: HG146 capsule HG146 capsule is a histone deacetylase inhibitor (HDAC inhibitor) for the treatment of multiple myeloma.

Other Name: HG280146, HG0146, HG280146, HG280146-P1

A Study of HG146 Capsule in Chinese Subjects With Relapsed and Refractory Multiple Myeloma

A Phase I Study of Single-centre, Open-label Clinical Trial to Evaluate HG146 Capsule in the Treatment of Relapsed and Refractory Multiple Myeloma

To determine the maximum tolerated dose of HG146 in relapsed and refractory multiple myeloma patients.

To determine the Peak Plasma Concentration of HG146.

To determine the Area under the plasma concentration versus time curve of HG146.

To determine the time of peak concentration of HG146.

To evaluate the incidence of adverse events that are related to treatments in relapsed and refractory myeloma patients.

To evaluate the incidence of laboratory abnormalities that are related to treatments in relapsed and refractory myeloma patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial of HG146 Administered to Subjects With Advanced Solid Tumors or Lymphoma	NCT04977167	Solid Tumor Lymphoma	HG146 PD-(L)1 antibod...	18 Years -	HitGen Inc.
Clinical Trial of HG146 Administered to Subjects With Advanced Solid Tumors or Lymphoma	NCT04977167	Solid Tumor Lymphoma	HG146 PD-(L)1 antibod...	18 Years -	HitGen Inc.
Clinical Trial of HG146 Administered to Subjects With Advanced Solid Tumors or Lymphoma	NCT04977167	Solid Tumor Lymphoma	HG146 PD-(L)1 antibod...	18 Years -	HitGen Inc.
A Study of HG146 Capsule in Chinese Subjects With Relapsed and Refractory Multiple Myeloma	NCT03710915	Multiple Myelom... Relapsed and Re...	HG146	18 Years - 75 Years	HitGen Inc.

Spots Global Cancer Trial Database for hg146

Every month we try and update this database with for hg146 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hg146

Every month we try and update this database with for hg146 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hg146 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.