QTX3034 / Quanta Therap - LARVOL DELTA

Preliminary clinical results of QTX3034, an oral G12D-preferring KRAS inhibitor, in combination with cetuximab ± mFOLFOX6 in patients with KRASG12D-mutated colorectal cancer (CRC) (ESMO 2026) - No abstract available

Clinical • Combination therapy • Colorectal Cancer • Oncology • Solid Tumor • KRAS

A phase 1 trial evaluating the safety, tolerability, PK, and preliminary efficacy of QTX3034, an oral G12D-preferring allosteric KRAS inhibitor, in patients with solid tumors with KRASG12D mutation. (AACR-NCI-EORTC 2025) - P1 | "QTX3034 demonstrates a favorable safety profile alone and in combination with cetuximab, with no unexpected AEs. The clinical PK, responses and anti-tumor activity support further development of this agent across multiple tumor types. This is the first presentation of a novel combination of KRAS inhibitor in combination with an EGFR inhibitor in PDAC, where anti-EGFR therapy has historically demonstrated minimal efficacy."

Clinical • Late-breaking abstract • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Discovery of QTX3034: A potent, selective and orally bioavailable KRASG12D preferring multi-KRAS allosteric inhibitor for KRASG12D-driven cancer treatment (ACS-Fall 2026) - P1 | "In a FIH, open-label phase 1 study in patients with advanced solid tumors with KRASG12D mutations (NCT06227377), QTX3034 has demonstrated a favorable safety profile alone and in combination with cetuximab, with no unexpected AEs. The clinical PK, responses and durable tumor control support further development of this agent across multiple tumor types. QTX3034 is the first KRAS inhibitor that has demonstrated clinical synergy of the KRASi/EGFRi combination in PDAC, where anti-EGFR therapy has historically shown minimal efficacy."

Colorectal Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

Acquired resistance to Tri-complex inhibitors in colorectal cancer (AACR 2026) - "For patients with advanced solid tumors harboring a KRAS G12D mutation, several selective inhibitors have entered clinical trials (MRTX1133, RMC-9805, QTX3034/46, LY3962673...) and RMC-6236, a pan-RAS inhibitor from Revolution Medicines, has recently shown promising early clinical data. This resistance can still be addressed by other KRAS G12D inhibitors, opening options for patients harboring this characteristic post RMC-therapy. Future investigations may focus on characterizing tumors from patients who relapse on RMC-6236 and RMC-9805 to validate these findings clinically."

Preclinical • Colorectal Cancer • Oncology • Solid Tumor • KRAS

Quanta Therapeutics Presents Preclinical Data Establishing that Direct Multi-KRAS Inhibitors Retain Strong Activity Against Resistance Mechanisms Acquired from Treatment with pan-RAS Tri-Complex Inhibitors (GlobeNewswire) - "The presentation will be given at the AACR Special Conference in Cancer Research: RAS Oncogenesis and Therapeutics....Direct multi-KRAS inhibitors, QTX3034 and QTX3544, exhibit potent activity against established and novel resistance mechanisms to daraxonrasib in KRAS-mutated colorectal cancer cells."

Preclinical • Colorectal Cancer

A phase 1 trial evaluating the safety, tolerability, PK, and preliminary efficacy of QTX3034, an oral G12D-preferring allosteric KRAS inhibitor, in patients with solid tumors with KRASG12D mutation (AACR-NCI-EORTC 2025) - P1 | "QTX3034 demonstrates a favorable safety profile alone and in combination with cetuximab, with no unexpected AEs. The clinical PK, responses and anti-tumor activity support further development of this agent across multiple tumor types. This is the first presentation of a novel combination of KRAS inhibitor in combination with an EGFR inhibitor in PDAC, where anti-EGFR therapy has historically demonstrated minimal efficacy."

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

Quanta Therapeutics Presents Positive Phase 1 Data for QTX3034, an Oral G12D-Preferring Multi-KRAS Inhibitor, in Patients with Advanced Solid Tumors (GlobeNewswire) - "The presentation was given at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics....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....As monotherapy, QTX3034 demonstrated a favorable safety profile and confirmed partial and complete responses in heavily pre-treated endometrial cancer patients."

P1 data • Colorectal Cancer • Endometrial Cancer • Pancreatic Ductal Adenocarcinoma

Quanta Therapeutics Announces First Clinical Data Presentation for QTX3034, an Oral G12D-Preferring Multi-KRAS Inhibitor, at 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "Quanta Therapeutics...will present Phase 1 clinical data on QTX3034..."

P1 data • Solid Tumor

Quanta Announces IND Clearance by U.S. FDA for QTX3544, an Oral G12V-Preferring Multi-KRAS Inhibitor, and Other Pipeline Updates (GlobeNewswire) - "Quanta Therapeutics...announced progress across its pipeline of KRAS-directed drug candidates, including U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application clearance for QTX3544, an oral G12V-preferring, dual ON/OFF state, multi-KRAS inhibitor, enabling initiation of a Phase 1 clinical trial...The Company has also initiated the combination portion of the ongoing Phase 1 clinical trial evaluating QTX3046, an oral KRASG12D-selective dual ON/OFF state allosteric inhibitor, with cetuximab...Additionally, the Phase 1 clinical trial evaluating QTX3034, an oral G12D-preferring multi-KRAS inhibitor, as a monotherapy and in combination with cetuximab, continues to enroll patients, and data is anticipated from this program in 2025."

IND • New P1 trial • P1 data • Colorectal Cancer • Pancreatic Adenocarcinoma • Solid Tumor

Quanta Announces Dosing of First Patient in Phase 1/1b Clinical Trial of QTX3046, an Oral KRASᴳ¹²ᴰ-Selective Dual-State Allosteric Inhibitor, and Other Program Updates (GlobeNewswire) - "Quanta Therapeutics...announced the advancement of two clinical trials from its pipeline of KRAS-directed drug candidates. The first patient has been dosed in the monotherapy portion of a Phase 1 clinical trial evaluating QTX3046, a KRAS^G12D-selective inhibitor, and patient dosing has begun in the combination portion of the ongoing Phase 1 clinical trial assessing QTX3034, G12D-preferring multi-KRAS inhibitor, and cetuximab. Both clinical trials are enrolling patients with KRASG12D-mutated advanced solid tumors. Quanta has also initiated GLP toxicology studies for QTX3544, its G12V-preferring KRAS inhibitor, that will support an investigational new drug (IND) submission anticipated in the fourth quarter of 2024."

IND • Trial status • Oncology • Solid Tumor

A phase 1 trial evaluating the safety, tolerability, PK, and preliminary efficacy of QTX3034, an oral G12D-preferring multi-KRAS inhibitor, in patients with solid tumors with KRAS G12D mutation. (ASCO 2024) - P1 | "To further optimize the recommended dose, patients will be randomized between two dose levels in the pancreatic cancer cohort. QTX3034 plus cetuximab will be explored following identification of a recommended combination dose in patients with CRC."

Clinical • P1 data • Endometrial Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

QTX3034-001: QTX3034 in Patients With KRAS G12D Mutation (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: Quanta Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • KRAS

QTX3034-001: Evaluate QTX3034 in Patients With KRAS G12D Mutation (clinicaltrials.gov) - P1 | N=250 | Not yet recruiting | Sponsor: Quanta Therapeutics

New P1 trial • Oncology • Solid Tumor • KRAS

Quanta Announces IND Clearance by U.S. FDA for QTX3034, G12D-Preferring Multi-KRAS Inhibitor, and Other Pipeline Updates (GlobeNewswire) - "Quanta Therapeutics...announced progress across its pipeline of KRAS-directed drug candidates, including U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application clearance for QTX3034, a multi-KRAS inhibitor with G12D-preferring activity (G12D+ multi-KRAS), enabling the initiation of a Phase 1 clinical trial in the first quarter of 2024. Additionally, QTX3046, a KRASG12D-selective inhibitor continues its advancement through IND-enabling activities positioning the company to file an IND in the first half of 2024. Further, the company has recently selected QTX3544, a multi-KRAS inhibitor with G12V-preferring activity (G12V+ multi-KRAS), as a development candidate, representing Quanta’s third KRAS inhibitor program."

IND • New P1 trial • Oncology • Solid Tumor

Quanta Announces IND Clearance by U.S. FDA for QTX3034, G12D-Preferring Multi-KRAS Inhibitor, and Other Pipeline Updates (GlobeNewswire) - "The QTX3034 Phase 1 clinical trial will initially enroll patients with KRASG12D mutations in dose escalation cohorts as monotherapy and in combination with cetuximab. Dose expansion cohorts consist of patients with KRASG12D-mutant pancreatic, colorectal, lung, and endometrial cancers. Endpoints include safety and tolerability, determination of the maximum tolerated dose/ recommended Phase 2 dose, pharmacokinetic properties, antitumor activity, and molecular markers. The study will be conducted at clinical sites in the US."

Clinical protocol • Colorectal Cancer • Endometrial Cancer • Lung Cancer • Oncology • Pancreatic Cancer

Quanta Therapeutics Presents Late-Breaking Data for QTX3034, a multi-KRAS inhibitor, at AACR-NCI-EORTC Conference (GlobeNewswire) - "Quanta Therapeutics...announced data from a late-breaking presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 11-15, 2023, in Boston, Massachusetts....The combination of QTX3034 and EGFR (epidermal growth factor receptor) inhibitors, a class of drugs used to treat many commonly occurring cancers, demonstrated potent, synergistic anti-tumor activity in preclinical studies....'These compelling data validate the potential of QTX3034 in combination with EGFR-targeted therapy across multiple cancer types and support the planned evaluation of this combination as part of our Phase 1 clinical development program, which is on track to begin in early 2024'."

Late-breaking abstract • New P1 trial • Preclinical • Oncology

QTX3034, a potent and selective multi-KRAS inhibitor, synergizes with EGFR inhibitors and enhances anti-tumor activity (AACR-NCI-EORTC 2023) - No abstract available

Late-breaking abstract • Oncology • KRAS

Quanta Therapeutics Raises Over $50 Million in Series D Financing to Advance its Pipeline of KRAS Inhibitors (GlobeNewswire) - "The proceeds from the financing will be used to advance Quanta’s pipeline including: Two chemically distinct allosteric KRAS inhibitors, QTX3034, a multi-KRAS inhibitor, and QTX3046, a G12D-selective KRAS inhibitor....These programs are currently in Investigational New Drug Application (IND)-enabling studies to support anticipated clinical trial initiation in KRAS-driven solid tumor indications in 2024."

Financing • New trial • Oncology

Discovery and characterization of QTX3034, a potent, selective, and orally bioavailable allosteric KRAS inhibitor (AACR 2023) - "QTX3034 exhibited weak CYP inhibition (direct and time-dependent) with a favorable in vitro off-target selectivity/safety profile. Taken together, this preclinical characterization supports the advancement of QTX3034 into IND-enabling studies for KRAS mutant cancers."

Late-breaking abstract • Oncology • BRAF • KRAS • NRAS

Quanta Therapeutics Presents Data from KRAS Inhibitor Pipeline at Annual AACR Meeting in Late-Breaking Research Session (GlobeNewswire) - "QTX3034...Demonstrated binding affinity to GDP-bound KRAS G12D/V mutant and wild-type proteins; binding prevents GTP exchange and locks KRAS in the GDP-bound inactive state, thereby disrupting the KRAS: RAF1 effector interaction....Exhibited potent, durable, and dose-responsive inhibition of MAPK/KRAS signaling in cells expressing human KRAS variants....Preclinical data support the advancement of QTX3034 into IND-enabling studies for clinical investigation in mutant KRAS-driven solid tumors."

Preclinical • Oncology • Solid Tumor

Quanta Therapeutics Announces Two Late-Breaking Preclinical Presentations from KRAS Inhibitor Pipeline at Annual AACR Meeting (GlobeNewswire) - "Quanta Therapeutics...announced the acceptance of two late-breaking abstracts for presentation at the American Association for Cancer Research (AACR) Annual Meeting being held April 14-19, 2023, in Orlando, Florida....AACR abstracts highlight the Company’s allosteric approach to developing novel, oral small-molecule medicines to treat RAS-driven cancer indications."

Late-breaking abstract • Preclinical • Oncology