TQB3454 / Sino Biopharm - LARVOL DELTA

A Phase II Study of IDH1 Inhibitor Combined With Serplulimab and Docetaxel in Previously Treated Advanced NSCLC (ChiCTR2400086196) (IASLC-WCLC 2025) - P2 | "Second-line therapeutic options remain limited: docetaxel demonstrates modest efficacy (objective response rate [ORR] 6-11%; median overall survival [mOS] 5-10 months), while PD-1 inhibitors (e.g., tislelizumab) show improved survival outcomes (ORR 21.9% vs. 7.0%; mOS 17.2 vs. 11.9 months compared to docetaxel)...This IDH1-mediated immunosuppressive niche may contribute to immunotherapy resistance, suggesting that IDH1 inhibition could restore immune sensitivity.TQB3454, a novel IDH1 inhibitor, exhibits superior preclinical safety and efficacy compared to AG-120 (ivosidenib)...Secondary: DCR, DOR, PFS, OS.Target accrual: 39 patients. MiniMax two-stage design (α=0.05, power=80%) with H0: ORR=7% (historical docetaxel) vs. H1: ORR=20%.Statistical Design: Survival endpoints analyzed by Kaplan-Meier method."

IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • CXCL12 • IDH1 • TGFB1

TQB3454 in mutant IDH1 advanced cholangiocarcinoma (CCA): Results of a phase I dose escalation and expansion study cohort (ESMO-GI 2024) - P1 | "These results suggest that TQB3454 has a manageable toxicity profile and notable clinical benefit in CCA pts with mutant IDH1. A phase III clinical trial aimed to further evaluate the efficacy and safety of TQB3454 for CCA with IDH1 mutations is currently underway."

IO biomarker • Metastases • P1 data • Anemia • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Hematological Disorders • Oncology • Renal Disease • Solid Tumor • IDH1

A Study of TQB3454 Tablets in Patients With Blood Tumors (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Clinical Trial of TQB3454 Tablets in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Trial completion date • Trial initiation date • Trial primary completion date • Biliary Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

A Clinical Trial of TQB3454 Tablets in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P1 trial • Biliary Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma. (clinicaltrials.gov) - P3 | N=165 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Metastases • New P3 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets (clinicaltrials.gov) - P1; N=96; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Trial primary completion date: Aug 2021 ➔ Dec 2022

Clinical • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets (clinicaltrials.gov) - P1; N=96; Recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets (clinicaltrials.gov) - P1; N=96; Not yet recruiting; Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clinical • New P1 trial • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor