IMP9064 / IMPACT Therap - LARVOL DELTA

Discovery and development of a potent and highly selective ATR inhibitor IMP9064 (AACR 2025) - P1/2 | "IMP9064 has entered a phase 1/2 study to evaluate the safety and efficacy either as monotherapy or in combination with PARP inhibitor Senaparib in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT05269316). The recommended phase 2 dose (RP2D) has been determined and IMP9064 is currently in expansion studies for selected tumors."

Colorectal Cancer • Oncology • Solid Tumor • PKMYT1

Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=61 | Recruiting | Sponsor: Impact Therapeutics, Inc. | Phase classification: P1 ➔ P1/2 | Trial completion date: Jul 2025 ➔ Dec 2026 | Trial primary completion date: Jul 2025 ➔ Dec 2026

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

Results from the first-in-human study of ATR inhibitor, IMP9064 monotherapy dose escalation in patients with advanced solid tumors (ESMO 2024) - P1 | "Here reports the results of Part 1 from the phase 1/2 study. The study consists of 4 parts: dose-escalation and dose-expansion of IMP9064 monotherapy and combination with senaparib (PARPi). IMP9064 has demonstrated a favorable safety profile and preliminary clinical efficacy signal and sustained clinical benefit in late-stage AST, which warrants further development of IMP9064. After RP2D is determined in May, enrollment in an expansion cohort will proceed."

Clinical • Metastases • Monotherapy • P1 data • Biliary Cancer • Cholangiocarcinoma • Endometrial Cancer • Gastrointestinal Cancer • Leiomyosarcoma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Uterine Corpus Leiomyosarcoma

Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=61 | Recruiting | Sponsor: Impact Therapeutics, Inc. | Phase classification: P1/2 ➔ P1

Combination therapy • Metastases • Monotherapy • Phase classification • Oncology • Solid Tumor

Shanghai Yingpai Pharmaceutical Co., Ltd.'s application for implied license for clinical trials of its drugs has been accepted [Google translation] (163.com) - "On July 19, according to the official website of CDE, Shanghai Yingpai Pharmaceutical Co., Ltd. jointly applied for the drug 'IMP9064 Tablets' and obtained implicit approval for clinical trials, acceptance number CXHB2400111....Public information shows that the indications of the drug 'IMP9064 Tablets': This product is intended for the treatment of advanced solid tumors."

New trial • Oncology • Solid Tumor

First-in-human study of ATR inhibitor IMP9064 monotherapy and in combination with PARP inhibitor senaparib in patients with advanced solid tumors (ESMO 2023) - P1/2 | "Conclusions These results indicate that IMP9064 monotherapy appears to be well-tolerated and support further dose escalation. More MRD and biomarker analyses are underway."

Clinical • Combination therapy • Metastases • Monotherapy • P1 data • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=61 | Recruiting | Sponsor: Impact Therapeutics, Inc.

Combination therapy • Monotherapy • New P1/2 trial • Oncology • Solid Tumor

IMPACT Therapeutics Announced ATR Inhibitor IMP9064 IND Clearance by FDA (PRNewswire) - "IMPACT Therapeutics announced that its ATR inhibitor IMP9064 has received the IND clearance from the U.S. Food and Drug Administration (FDA) for the Phase I/II clinical study, which will begin soon in the U.S. This will be the first in human study for the ATR inhibitor of IMPACT Therapeutics, representing a major leap of the company's global development strategy for its synthetic lethality pipelines."

New P1/2 trial • Oncology • Solid Tumor

Burning Rock Collaborates with IMPACT Therapeutics to Provide Testing Services in Developing IMP9064 in both US and China (GlobeNewswire) - "Burning Rock Biotech Limited...today announced a collaboration with IMPACT Therapeutics where Burning Rock provides testing services in connection with IMPACT Therapeutics’ development of its ATR inhibitor IMP9064, which has received the Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the Phase I/II clinical study, and will begin soon in the U.S. The collaboration will be supported by Burning Rock’s Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathologists (CAP) accredited labs in Guangzhou, China and California, U.S."

Diagnostic • IND • Licensing / partnership • New P1/2 trial • Oncology • Solid Tumor