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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of multiple myeloma requiring systemic therapy (International Myeloma Working Group [IMWG]) and 2 cycles of treatment including proteasome inhibitors and/or immunomodulators.
  • - Serum M protein≥ 10.0g / L, or urine M protein ≥ 200mg / 24h.
  • - Not suitable for autologous bone marrow transplantation or refuse autologous bone marrow transplantation or relapse after autologous bone marrow transplantation.
  • - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2.
  • - Expected survival of ≥3 months.
  • - Hemoglobin ≥ 80 g/L, Platelet≥75×10^9/L, Absolute Neutrophil Count≧1.0×109/L (1000 cells/mm3), Prothrombin time(PT) and activated partial thromboplastin time ≤ 2 x Upper Limit of Normal (ULN).
  • - Bilirubin in serum<1.5*ULN (2.0mg/dL/20mg/L/34.2μmol/L); glutamic-pyruvic transaminase (ALT) and/or Aspartate Aminotransferase (AST)≤3*ULN (upper limit of normal).
  • - Normal electrocardiogram, echocardiography and myocardial enzyme spectrumCalibration of blood calcium concentration≤ULN.
  • - Men and women, Non-pregnant women who did not consider giving birth during the trial or five years after the end of the trial.
  • - The patient is able to swallow the capsule.
  • - Patients must provide written consent.

Exclusion Criteria:

  • - Severe allergies to the study drug or any of its excipients.
  • - The possibility of gene toxicity, mutagenesis and teratogenicity.
  • - Men and women who did not have sperm or egg cells stored in vitro before the trial and who planned to have children again within five years.
  • - Pregnant or lactating women.
  • - Perform autologous bone marrow transplantation 3 months before admission.
  • - Receive allogeneic bone marrow transplantation.
  • - Use HDAC inhibitors before.
  • - Two weeks prior to admission, received radiotherapy or bone marrow suppressive chemotherapy or biological treatment.
  • - Patients with history of other malignant tumors, except the tumor is in remission and has not been treated for at least 5 years.
  • - Patients with dysphagia or oral absorption disorder.
  • - The investigators determine the conditions not suitable for the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

HitGen Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ting Liu, M.D.
Principal Investigator Affiliation The West China Hospital of Sichuan University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma, Relapsed and Refractory Multiple Myeloma
Additional Details

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.

Arms & Interventions


Experimental: HG146 capsule treat multiple myeloma

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


Drug: - HG146

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

HitGen Inc, Chengdu, Sichuan, China




HitGen Inc

Chengdu, Sichuan, 610200

Site Contact

Jie Shen, M.S


+86 2885197385 #8211