Quanta Therapeutics Presents Positive Phase 1 Data for QTX3034, an Oral G12D-Preferring Multi-KRAS Inhibitor, in Patients with Advanced Solid Tumors

– QTX3034 monotherapy and the QTX3034-cetuximab combination demonstrated favorable safety profiles and clear clinical proof of concept, including confirmed responses in CRC, PDAC, and endometrial cancer –

– First clinical activity reported for the combination of KRAS and EGFR inhibition in KRAS G12D-mutated cancers, including CRC and PDAC –

– Data support ongoing dose expansion and evaluation of combinations with standard-of-care agents, including front-line chemotherapy –

RADNOR, Pa., and SOUTH SAN FRANCISCO, Calif., Oct. 24, 2025 (GLOBE NEWSWIRE) -- Quanta Therapeutics, a privately held, clinical-stage biopharmaceutical company leading the development of innovative oral therapeutics for RAS-driven cancers, today presented positive Phase 1 clinical data for QTX3034, an oral, G12D-preferring, multi-KRAS inhibitor, as a monotherapy and in combination with cetuximab, a widely used EGFR inhibitor. The presentation was given at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics held in Boston, Mass.

The QTX3034-cetuximab combination displayed compelling anti-tumor activity, including several responses in patients with colorectal cancer (CRC) and pancreatic adenocarcinoma (PDAC). The combination was well-tolerated with a safety profile consistent with cetuximab treatment. These data represent the first disclosure of the combination of KRAS and EGFR inhibition in G12D-mutated disease, including the first report of clinical activity in CRC and PDAC. As monotherapy, QTX3034 demonstrated a favorable safety profile and confirmed partial and complete responses in heavily pre-treated endometrial cancer patients.

“There is an urgent need for new therapeutic approaches in cancers like CRC, PDAC, and endometrial cancer,” said Dr. Ignacio Garrido-Laguna, MD, PhD, Principal Investigator at Huntsman Cancer Institute at the University of Utah. “The promising clinical benefit demonstrated by QTX3034 alone and in combination with cetuximab in a heavily pretreated group of patients is encouraging, underscoring QTX3034’s potential as a targeted treatment in these G12D-mutated solid tumors.”

“The robust synergy of QTX3034 and cetuximab observed in preclinical disease models is bearing out in the clinic. Our initial clinical data clearly highlight that combined inhibition of KRAS G12D and EGFR translates into meaningful clinical benefit for patients, in both CRC and PDAC,” said Leonardo Faoro, MD, MBA, Chief Medical Officer of Quanta Therapeutics. “Based on this exciting clinical signal and the favorable safety profile that supports combining QTX3034 more broadly, we are expeditiously moving this program forward. The dose expansion portion of the study is well underway, and we are exploring additional combinations, including standard of care treatments, such as immune checkpoint inhibitors and chemotherapy."

The Phase 1 dose escalation portion of the clinical trial includes two parts: evaluation of QTX3034 monotherapy at doses ranging from 75 mg BID to 1200 mg BID in patients with advanced or metastatic solid tumors (n=42), and evaluation of QTX3034 at doses ranging from 150 mg BID to 1200 mg BID in combination with cetuximab in patients with advanced or metastatic CRC and PDAC (n=29).

Phase 1 dose escalation data, using a September 23, 2025 cutoff, are summarized as follows:

• QTX3034 monotherapy demonstrated a meaningful clinical signal at the recommended Phase 2 dose (RP2D) of 1200 mg BID; notably, responses were shown for patients with heavily pre-treated endometrial cancer, including a confirmed complete response.
• The QTX3034-cetuximab combination achieved significant anti-tumor activity in patients with refractory CRC and PDAC. Many patients at the RP2D showed marked reduction in tumor lesions, including four partial responses.
• QTX3034 was well tolerated with primarily low grade, manageable adverse events. The most common adverse events with QTX3034 monotherapy were GI-related. For patients receiving the combination regimen, overall tolerability was consistent with the known side effect profile of cetuximab.
• No dose-limiting toxicities (DLTs) were observed at any dose level, and no treatment-related adverse events of grade 3 or greater were observed at the RP2D of QTX3034 monotherapy. No rash of any grade was reported with QTX3034 monotherapy at the RP2D.
• Pharmacokinetic data demonstrated oral bioavailability, with exposures at the highest dose exceeding preclinical benchmarks associated with greater than 90% G12D target inhibition.
• A strong molecular response (>90% G12D ctDNA reduction) was observed with both monotherapy and combination treatments, correlating with anti-tumor activity.

“We’re excited to share the first clinical data emerging from our scientific platform, validating Quanta’s differentiated approach to targeting RAS-driven cancers,” said Perry Nisen, MD, PhD, Chief Executive Officer of Quanta. “QTX3034’s unique multi-KRAS activity coupled with an encouraging safety profile have delivered compelling clinical signals with both monotherapy and in combination. This milestone is a significant step forward and reinforces the potential of our allosteric KRAS inhibitor pipeline in targeting difficult-to-treat cancers.”

About QTX3034
QTX3034 is a multi-KRAS inhibitor with G12D-preferring activity in an ongoing Phase 1 clinical trial in patients with solid tumors with KRAS G12D mutations. Dose escalation cohorts are evaluating QTX3034 as monotherapy and in combination with cetuximab. Dose expansion cohorts are enrolling patients with KRAS G12D mutant pancreatic, colorectal, and endometrial cancers. The Phase 1 clinical endpoints include safety and tolerability, determination of the maximum tolerated dose/recommended Phase 2 dose, pharmacokinetic properties, anti-tumor activity, and molecular markers. The clinical trial is being conducted at clinical sites in the US. More information about the QTX3034 clinical trial (NCT06227377) can be found on https://clinicaltrials.gov/.

About Quanta Therapeutics
Quanta Therapeutics is a private biopharmaceutical company focused on the most prevalent and elusive target in oncology—RAS. Our vision is to develop novel small molecule cancer medicines by selectively targeting protein-protein interactions that are key to oncogenic RAS activity. Driving Quanta's success is our unique high-throughput platform that applies Second Harmonic Generation (SHG) optical technology to identify allosteric modulators of protein complexes. The Quanta team has extensive drug development expertise and substantial research experience in the RAS space. By applying innovative medicinal chemistry and its unique protein conformation detection technology, Quanta aims to advance differentiated, next-generation RAS programs that address the resistance paradigms of targeted therapy in oncology. Quanta’s KRAS inhibitor pipeline includes: QTX3034, a multi-KRAS inhibitor with G12D-preferring activity (G12D+ multi-KRAS), currently in a Phase 1clinical trial as monotherapy and in combination with cetuximab and QTX3544, a multi-KRAS inhibitor with G12V-preferring activity (G12V+ multi-KRAS), currently in a Phase 1 clinical trial as a monotherapy and in combination in patients with KRAS G12V-driven solid tumors. Quanta is headquartered in South San Francisco, CA, and has a site in Radnor, PA. Find more information at https://www.quantatx.com/. Follow us on LinkedIn: Quanta Therapeutics

CONTACT: Quanta Therapeutics
Heather Meeks
661-992-6907
heather.meeks@quantatx.com

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