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TerminatedNCT03710915Updated Oct 10, 2024

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

A Phase 1 interventional study of HG146 in Multiple Myeloma and Relapsed and Refractory Multiple Myeloma, sponsored by HitGen Inc.. Terminated at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by HitGen Inc. · Phase 1, Interventional, and Treatment

Why this study was terminated
Company decision
Phase
Phase 1
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Multiple Myeloma
  • Relapsed and Refractory Multiple Myeloma

Keywords

  • HDAC inhibitor
  • Dose escalation
  • HG146
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • 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

Interventions

  • DrugHG146

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

    Also known as: HG280146, HG0146, HG280146, HG280146-P1

05

What researchers measure

Primary outcomes

  1. Maximum tolerated dose of HG146

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

    Time frame: Up to 3 months

Secondary outcomes

  1. Peak Plasma Concentration (Cmax)

    To determine the Peak Plasma Concentration of HG146.

    Time frame: In cycle 1 (each cycle is 21 days)

  2. Area under the plasma concentration versus time curve (AUC)

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

    Time frame: In the middle of cycle 1 (each cycle is 21 days)

  3. Time of Peak Concentration (Tmax)

    To determine the time of peak concentration of HG146.

    Time frame: In the middle of cycle 1 (each cycle is 21 days)

  4. Half life (T1/2)

    To determine the half-life of HG146.

    Time frame: In the middle of cycle 1 (each cycle is 21 days)

  5. Incidence of adverse events related to treatments

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

    Time frame: Up to 21 days after last dose

  6. Incidence of laboratory abnormalities related to treatments

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

    Time frame: Up to 1 month after last dose

06

Study locations

1 site
  • HitGen Inc
    Chengdu, Sichuan 610200, China
07

References and documents

Publications

  • Huang B, Lu J, Wang X, Xiao Y, Zhao Y, Huang H, Liu J, Chen M, Gu J, Yuan S, Zheng D, Li Y, Huang X, Li J. Prognostic value of lactate dehydrogenase in Chinese patients with newly diagnosed transplant eligible multiple myeloma. Leuk Lymphoma. 2017 Jul;58(7):1740-1742. doi: 10.1080/10428194.2016.1252975. Epub 2016 Nov 23. No abstract available. PubMed 27881052 ↗
  • Lu J, Lu J, Chen W, Huo Y, Huang X, Hou J; Chinese Medical Doctor Association Hematology Branch. Clinical features and treatment outcome in newly diagnosed Chinese patients with multiple myeloma: results of a multicenter analysis. Blood Cancer J. 2014 Aug 15;4(8):e239. doi: 10.1038/bcj.2014.55. PubMed 25127393 ↗
  • Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26. PubMed 25439696 ↗
  • Durie BG, Salmon SE. A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival. Cancer. 1975 Sep;36(3):842-54. doi: 10.1002/1097-0142(197509)36:33.0.co;2-u. PubMed 1182674 ↗
  • Palumbo A, Avet-Loiseau H, Oliva S, Lokhorst HM, Goldschmidt H, Rosinol L, Richardson P, Caltagirone S, Lahuerta JJ, Facon T, Bringhen S, Gay F, Attal M, Passera R, Spencer A, Offidani M, Kumar S, Musto P, Lonial S, Petrucci MT, Orlowski RZ, Zamagni E, Morgan G, Dimopoulos MA, Durie BG, Anderson KC, Sonneveld P, San Miguel J, Cavo M, Rajkumar SV, Moreau P. Revised International Staging System for Multiple Myeloma: A Report From International Myeloma Working Group. J Clin Oncol. 2015 Sep 10;33(26):2863-9. doi: 10.1200/JCO.2015.61.2267. Epub 2015 Aug 3. PubMed 26240224 ↗
  • Lu J, Lee JH, Huang SY, Qiu L, Lee JJ, Liu T, Yoon SS, Kim K, Shen ZX, Eom HS, Chen WM, Min CK, Kim HJ, Lee JO, Kwak JY, Yiu W, Chen G, Ervin-Haynes A, Hulin C, Facon T. Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. Br J Haematol. 2017 Mar;176(5):743-749. doi: 10.1111/bjh.14465. Epub 2017 Jan 20. PubMed 28106903 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03710915
Lead sponsor
HitGen Inc.
Responsible party
Sponsor
First posted
Oct 18, 2018
Start date
Jan 12, 2019
Primary completion
Sep 28, 2022
Completion
Jun 28, 2023
Last update
Oct 10, 2024

Study contacts

Ting Liu, M.D.
principal investigator · The West China Hospital of Sichuan University

Oversight

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

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