HA121-28 / CSPC Pharma - LARVOL DELTA

HA121-28 Shows Promising Efficacy in Advanced RET Fusion+ NSCLC (Cancer Network) - P1 | N=44 | NCT03994484 | P2 | N=83 | NCT05117658 | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | "The confirmed objective response rate (ORR) in this patient population was 26.8% (95% CI, 18.3%-36.8%) per investigator assessment. All responses were partial responses (PRs), and the disease control rate (DCR) was 72.2% (95% CI, 62.1%-80.8%). Additionally, among patients with CCDC6-RET fusions, the confirmed ORR per investigator assessment was 46.7% (95% CI, 21.3%-73.4%), and the median duration of response (DOR) was 14.0 months (95% CI, 5.8-not estimable [NE]). Furthermore, those with KIF5B-RET fusions had an investigator-assessed ORR of 25.4% (95% CI, 15.8%-37.1%) and a median DOR of 7.7 months (95% CI, 3.7-NE). The median progression-free survival (PFS) in this patient cohort was 5.5 months (95% CI, 3.8-7.6), including 14.9 months (95% CI, 6.5-NE) among those with CCDC6-RET fusions and 5.5 months (95% CI, 3.6-7.0) in patients with KIF5B-RET fusions."

P1/2 data • Non Small Cell Lung Cancer

Safety, pharmacokinetics and efficacy of HA121-28 in patients with advanced solid tumors and RET fusion-positive non-small-cell lung cancer: a multicenter, open-label, single-arm phase 1/2 trial. (PubMed, Signal Transduct Target Ther) - P1, P2 | "HA121-28 showed encouraging efficacy in advanced RET fusion NSCLC and its toxicity was tolerable in most patients. Nevertheless, cardiotoxicity is a notable concern that warrants careful attention."

Journal • P1/2 data • PK/PD data • Cardiovascular • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • FGFR1 • RET

Effects of Food on the Pharmacokinetics and Safety of HA121-28 Tablet, a Novel Multi-Targeting Tyrosine Kinase Inhibitor, in Healthy Chinese Subjects: A Phase I Clinical Trial. (PubMed, Drug Des Devel Ther) - "The exposure of HA121-28 was not significantly affected by the high-fat and high-calorie food. The clinical application of HA121-28 tablet can be recommended for use in both fasted and postprandial states."

Clinical • Journal • P1 data • PK/PD data • Oncology

A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=31 | Terminated | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Trial completion date: Dec 2024 ➔ Dec 2022 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Dec 2022; The primary endpoint did not meet expectation.

Metastases • Trial completion date • Trial primary completion date • Trial termination • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

[VIRTUAL] A single-arm, open-label, multi-center, phase I study of HA121-28 in patients with advanced solid tumors (ESMO 2021) - P1 | "HA121-28 showed a tolerable safety profile with encouraging efficacy among RET fusion+ NSCLC pts."

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RET

Study of HA121-28 in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=83 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RET

A Study to Evaluate Relative Bioavailability and Food-Effect of HA121-28 Tablet B in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting ➔ Completed

Trial completion

Study of HA121-28 in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=83 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Initiation date: Nov 2021 ➔ Mar 2022 | Trial primary completion date: Mar 2023 ➔ Oct 2023

Trial initiation date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RET

Study of Dosage Exploration and Pharmacokinetics for HA121-28 Tablets (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Trial completion date: Dec 2020 ➔ Dec 2022 | Trial primary completion date: Aug 2020 ➔ Dec 2022

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study to Evaluate Relative Bioavailability and Food-Effect of HA121-28 Tablet B in Healthy Subjects (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Study of HA121-28 in Patients With Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=83; Not yet recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Clinical • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RET

A Study to Evaluate Relative Bioavailability and Food-Effect of HA121-28 Tablet B in Healthy Subjects (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Clinical • New P1 trial

A Study of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC) (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma

A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Clinical • New P2 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC) (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Clinical • New P2 trial • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma

Study of Dosage Exploration and Pharmacokinetics for HA121-28 Tablets (clinicaltrials.gov) - P1; N=44; Recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Trial completion date: Dec 2019 ➔ Dec 2020; Initiation date: Apr 2018 ➔ Oct 2018; Trial primary completion date: Nov 2019 ➔ Aug 2020

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Newly added product (clinicaltrials.gov) - P1, Solid Tumor

Pipeline update