Phase 1 Clinical Trial Underway for QTX3046 in KRASG12D-Mutated Advanced Solid Tumors

Quanta Therapeutics, a clinical-stage biopharmaceutical company, has made significant progress in its pipeline of KRAS-directed drug candidates. The company has dosed the first patient in the monotherapy portion of a Phase 1 clinical trial evaluating QTX3046, a novel orally bioavailable and brain-penetrant, non-covalent allosteric G12D-selective-KRAS dual (OFF/ON)-state inhibitor, in patients with KRASG12D-mutated advanced solid tumors. Additionally, patient dosing has begun in the combination portion of the ongoing Phase 1 clinical trial assessing QTX3034, a G12D-preferring multi-KRAS inhibitor, and cetuximab, an EGFR inhibitor, for patients with KRASG12D-mutated colorectal cancer.

Quanta has also initiated GLP toxicology studies for QTX3544, its G12V-preferring KRAS inhibitor, to support an investigational new drug (IND) submission anticipated in the fourth quarter of 2024. These developments underscore Quanta's commitment to addressing the significant unmet need for patients with KRAS-mutated cancers beyond G12C.

Leonardo Faoro, MD, MBA, Chief Medical Officer of Quanta Therapeutics, highlighted the potential of combining KRAS and EGFR inhibitors for treating G12D-mutated cancers, emphasizing the need for oral small molecules with direct inhibition of the target for combination treatments. Perry Nisen, MD, PhD, Chief Executive Officer, expressed optimism about the progress of Quanta's novel KRAS inhibitors targeting G12D and G12V mutations, leveraging the company's proprietary research and translational platform.

The Phase 1 clinical trials for QTX3034 and QTX3046 are enrolling patients with KRASG12D mutations in dose escalation cohorts as monotherapy and in combination with cetuximab. The trials aim to evaluate safety, tolerability, maximum tolerated dose, pharmacokinetic properties, antitumor activity, and molecular markers. Dose expansion cohorts will include patients with KRASG12D-mutant pancreatic, colorectal, lung, and endometrial cancers.

Quanta Therapeutics is at the forefront of developing novel small molecule cancer medicines by selectively targeting protein-protein interactions crucial to oncogenic RAS activity. The company's unique high-throughput platform, utilizing Second Harmonic Generation (SHG) optical technology, identifies allosteric modulators of protein complexes, advancing differentiated, next-generation RAS programs to overcome resistance paradigms in oncology.