basroparib (STP1002) / Dong-A - LARVOL DELTA

A First-In-Human Dose-Escalation Phase 1 Study of Basroparib (STP1002), a Tankyrase Inhibitor, in Patients with Advanced-Stage Solid Tumors. (PubMed, Cancer Res Commun) - P1 | "Basroparib (STP1002) was shown to be a safe and well-tolerated tankyrase-selective inhibitor with preliminary anti-tumor activity warranting further investigation."

Clinical • First-in-human • Journal • P1 data • Colorectal Cancer • Fatigue • Oncology • Solid Tumor • APC

Basroparib overcomes acquired resistance to MEK inhibitors by inhibiting Wnt-mediated cancer stemness in KRAS-mutated colorectal cancer. (PubMed, Biochem Pharmacol) - "Mechanistically, basroparib suppressed Wnt-mediated cancer stemness, a bypass mechanism for acquired resistance to MEK inhibitors in KRAS-mutated CRC. This study provides the first preclinical evidence of the relevance of basroparib in treating CRC with acquired resistance to MEK inhibitors due to APC and KRAS mutations, possibly by reducing the Wnt-mediated cancer stemness."

Journal • Preclinical • Colorectal Cancer • Oncology • Solid Tumor • APC • KRAS

ST Pharm's phase 1 study of anticancer drug basroparib shows safety at ESMO 2024 (Korea Biomedical Review) - P1 | N=32 | NCT04505839 | Sponsor: ST Pharm Co., Ltd. | "ST Pharm said it presented the detailed results of its phase 1 clinical trial for basroparib (STP1002), a tankyrase-targeting anticancer drug, at the European Society for Medical Oncology (ESMO) Congress 2024....A total of 25 patients participated in the trial, including 23 with colorectal cancer and 2 with renal cancer.....In terms of safety, most of the 25 treatment-related adverse events (TRAEs) observed were mild (Grade 1-2), such as fatigue and nausea....Antitumor efficacy was evaluated in 17 patients, with four demonstrating stable disease (SD). Pharmacokinetic analysis showed a dose-dependent increase in drug exposure, with a half-life of approximately six to seven hours."

P1 data • Colorectal Cancer • Renal Cell Carcinoma

First-in-human dose-escalation study of basroparib (STP1002) in patients with advanced-stage solid tumors (ESMO 2024) - P1 | "In this dose escalation study, Basroparib (STP1002) was shown to be a safe and well-tolerated TNKS1 and TNKS2 inhibitor with preliminary anti-tumor activity warranting further investigation."

Clinical • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • APC • PARP1 • TNKS2

Estifam, Tankirase Anticancer Drug STP1002 Phase 1 Clinical Trial Results [Google translation] (Medipana) - P1 | N=32 | NCT04505839 | Sponsor: ST Pharm Co., Ltd. | "On the 9th, ST Pharm announced the 'Results of the Phase 1 Clinical Trial of Tankyrase Anticancer Drug STP1002'....According to the clinical trial results, no dose-limiting toxicity reactions were observed, so the maximum tolerated dose was not set. However, the MTD (maximum tolerated dose: 360 mg) and RP2D (recommended phase 2 dose: 360 mg) were determined by collecting the opinions of the SMC (Safety Monitoring Committee) members based on the statistical analysis results and pharmacokinetic data for all cohorts. Detailed results of the phase 1 clinical trial are scheduled to be presented at the ESMO Congress 2024, to be held in Barcelona, ​​Spain from September 13 to 17."

P1 data • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: ST Pharm Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: ST Pharm Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: May 2023 ➔ Sep 2023

Enrollment closed • Metastases • Trial primary completion date • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Tankyrase-selective inhibitor STP1002 reverses resistance to MEK inhibitors in colorectal cancer with KRAS mutations (AACR 2023) - "Dual combination of STP1002 and MEK inhibitor is a promising candidate to overcome resistance to MEK inhibitors in colorectal cancer with KRAS-G12V/G12D mutations. The phase 1 clinical trial study is ongoing in order to show safety margin."

Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

Korean biopharmas rush to unveil pipeline developments at AACR 2023 (Korea Biomedical Review) - P1 | N=66 | STCUBE-001 (NCT05231746) | Sponsor: STCube, Inc. | "ST Pharm will present preclinical results from the combination therapy STP1002, a candidate for the treatment of advanced solid tumors, and MEK inhibitor....ST Cube will present pharmacokinetic and immunophenotyping data from its phase 1 clinical trial of the immune checkpoint inhibitor, nelmastobart, and the development of an anti-BTN1A1 diagnostic antibody....According to ST Cube, nelmastobart showed no dose-limiting toxicity at the highest dose, and the company observed efficacy in patients at intermediate and high doses and in patients with refractory solid tumors."

P1 data • PK/PD data • Preclinical • Oncology • Solid Tumor

First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: ST Pharm Co., Ltd. | Trial completion date: Mar 2022 ➔ Sep 2023 | Trial primary completion date: Dec 2021 ➔ May 2023

Metastases • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Tankyrase-selective inhibitor STP1002 shows preclinical antitumour efficacy without on-target toxicity in the gastrointestinal tract. (PubMed, Eur J Cancer) - "These results demonstrate that STP1002, a novel, orally active tankyrase inhibitor, shows preclinical antitumour efficacy without on-target toxicity in the GI tract. Our data provide a rationale for a clinical trial on STP1002 as a potential tankyrase-targeted drug in patients with APC-mutated CRC."

Journal • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor • APC • PARP1

First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: ST Pharm Co., Ltd.; Trial completion date: Jul 2021 ➔ Mar 2022; Trial primary completion date: Mar 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: ST Pharm Co., Ltd.

Clinical • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ST Pharm submits IND application for colorectal cancer treatment in US (Korea Biomedical Review) - "ST Pharm said that it has submitted an investigational new drug application to the U.S. Food and Drug Administration for STP1002, a colorectal cancer treatment candidate. The company plans to confirm the safety and efficacy of the drug while trying to expand the candidate’s indications to treat patients with advanced solid cancers such as non-small cell lung cancer and breast cancer, it added."

IND