TQB3602 / Sino Biopharm - LARVOL DELTA

Phase I study of TQB3602, an oral proteasome inhibitor, in relapsed and refractory multiple myeloma. (PubMed, Cancer Med) - "TQB3602 is well tolerated, with a favorable neurotoxicity profile, and has shown preliminary efficacy in patients with RRMM. The anticipated therapeutic dose was 6 mg and was adopted for an ongoing dose-expansion phase."

Journal • P1 data • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Pain • Peripheral Neuropathic Pain

Clinical Trial of the TQB3602 Capsule Combined With AK105 Injection in Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=7 | Active, not recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | N=63 ➔ 7 | Trial primary completion date: May 2023 ➔ Dec 2023

Enrollment change • Enrollment closed • Metastases • Trial primary completion date • Oncology • Solid Tumor

Phase I Study of a Novel Oral Proteasome Inhibitor TQB3602 in Relapsed/Refractory Multiple Myeloma (ASH 2022) - P1 | "Background: TQB3602 is a novel oral proteasome inhibitor with an acridine ring in addition to the main structure of ixazomib, which maintains better metabolic stability and higher activity and selectivity in preclinical models of multiple myeloma...The inclusion criteria mainly include: 1) 18 to 75 years old male or female, 2) ECOG score of 0 to 2, 3) Life expectancy ≥12 weeks, 4) RRMM had received at least two treatment regimens (including lenalidomide or thalidomide, bortezomib, and glucocorticoid)...According to prior lines of therapy, patients with RRMM were divided into two dose expansion cohorts, including TQB3602/lenalidomide/dexamethasone and TQB306/pomalidomide/dexamethasone (TQB3602 6mg on days 1, 8, 15, lenalidomide 25mg daily or pomalidomide 4mg daily on days 1 to 21, dexamethasone 20mg on days 1-2, 8-9, 15-16, 22-23 in a 28-day cycle)... TQB3602 is generally well tolerated. The combination therapy has shown preliminary efficacy in RRMM, and further..."

P1 data • Anemia • Bone Marrow Transplantation • Fatigue • Hematological Disorders • Hematological Malignancies • Immune Modulation • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Pain • Respiratory Diseases • Thrombocytopenia • Transplantation

PHASE I STUDY OF TQB3602 CAPSULE, AN ORAL PROTEASOME INHIBITOR, IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (EHA 2022) - P1 | "Adult patients with RRMM who had received at least two kinds of therapy, including bortezomib, lenalidomide or thalidomide, are enrolled...Results Twenty-five patients with RRMM (16 males, 9 females, median age 65, range 37-73) were enrolled between May 2020 and October 2021, with all patients exposed to bortezomib and three patients exposed to ixazomib...Conclusion TQB3602 is well tolerated with no severe neuropathy adverse events and has shown preliminary efficacy in patients with RRMM. Based on the efficacy, safety, and pharmacokinetic data, 6mg was recommended as the anticipated therapeutic dose and adopted in an ongoing dose-expansion phase."

P1 data • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Pain • Thrombocytopenia

Clinical Trial of the TQB3602 Capsule Combined With AK105 Injection in Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=63 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial • Oncology • Solid Tumor

[VIRTUAL] Preclinical evaluation of TQB3602, a small molecule proteasome inhibitor clinical candidate. (ASCO 2020) - "Bortezomib (Velcade), the first approved therapeutic proteasome inhibitor with a unique boronic acid as warhead, limited by its requirement for parenteral administration (intravenous or subcutaneous). The 2nd generation boronic acid – orally bioavailable Ixazomib (Ninlaro) was approved in 2015 by FDA greatly improved patient’s compliance... We have identified a novel potent proteasome inhibitor TQB3602. Preclinical studies showed antitumor efficacy of TQB3602 in MM.1S multiple myeloma model. TQB3602 represents a promising clinical candidate for treating multiple myeloma and the First-in-human trial is expected in the middle of 2020."

Hematological Malignancies • Immune Modulation • Inflammation • Multiple Myeloma • Oncology • Targeted Protein Degradation

A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3602 Capsule (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting; Initiation date: Feb 2020 ➔ May 2020

Clinical • Enrollment open • Trial initiation date • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology

A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3602 Capsule (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clinical • New P1 trial