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

• Status: Recruiting
• Trial end date: 2022-06-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HitGen Inc.; HitGen Ltd

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.