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

September 20, 2023 updated by: HitGen Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610200
        • HitGen Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other Names:
  • HG280146, HG0146, HG280146, HG280146-P1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose of HG146
Time Frame: Up to 3 months
To determine the maximum tolerated dose of HG146 in relapsed and refractory multiple myeloma patients.
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: In cycle 1 (each cycle is 21 days)
To determine the Peak Plasma Concentration of HG146.
In cycle 1 (each cycle is 21 days)
Area under the plasma concentration versus time curve (AUC)
Time Frame: In the middle of cycle 1 (each cycle is 21 days)
To determine the Area under the plasma concentration versus time curve of HG146.
In the middle of cycle 1 (each cycle is 21 days)
Time of Peak Concentration (Tmax)
Time Frame: In the middle of cycle 1 (each cycle is 21 days)
To determine the time of peak concentration of HG146.
In the middle of cycle 1 (each cycle is 21 days)
Half life (T1/2)
Time Frame: In the middle of cycle 1 (each cycle is 21 days)
To determine the half-life of HG146.
In the middle of cycle 1 (each cycle is 21 days)
Incidence of adverse events related to treatments
Time Frame: Up to 21 days after last dose
To evaluate the incidence of adverse events that are related to treatments in relapsed and refractory myeloma patients.
Up to 21 days after last dose
Incidence of laboratory abnormalities related to treatments
Time Frame: Up to 1 month after last dose
To evaluate the incidence of laboratory abnormalities that are related to treatments in relapsed and refractory myeloma patients.
Up to 1 month after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HitGen Inc.

Investigators

  • Principal Investigator: Ting Liu, M.D., The West China Hospital of Sichuan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2019

Primary Completion (Actual)

September 28, 2022

Study Completion (Actual)

June 28, 2023

Study Registration Dates

First Submitted

September 29, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HG146-I-CRP-1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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