QTX3544 / Quanta Therap - LARVOL DELTA

QTX3544-201: QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations (clinicaltrials.gov) - P1 | N=237 | Active, not recruiting | Sponsor: Quanta Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • 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

QTX3544, a potent and selective G12V-preferring KRAS inhibitor, synergizes with EGFR inhibitors for enhanced anti-tumor activity (AACR 2025) - "We examined the potential synergy between QTX3544 and EGFR inhibitors (afatinib and cetuximab) in KRASG12V-driven cancer cell lines and tumor models. Co-administration of QTX3544 and cetuximab significantly enhanced anti-tumor efficacy and elicited greater tumor regressions in the Capan-2 pancreatic and SW-403 colorectal KRASG12V-mutant cell line-derived xenograft models (CDX), as well as in a patient-derived colorectal tumor xenograft model (PDX), compared to monotherapy. Taken together, these preclinical data support the clinical strategy to combine QTX3544 and cetuximab to enhance the depth and breadth of therapeutic activity against KRASG12V-driven cancers."

Late-breaking abstract • Colorectal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • HRAS • KRAS • NRAS

Quanta Therapeutics Presents Late-Breaking Data for QTX3544, an Oral G12V-Preferring Multi-KRAS Inhibitor, at AACR Annual Meeting 2025 (GlobeNewswire) - "Studies evaluating the potential synergy between QTX3544 and EGFR inhibitors (afatinib and cetuximab) in KRASG12V-driven cancer cell lines and tumor models demonstrated: QTX3544 synergized with EGFR inhibitors and potently inhibited KRASG12V-mutant cell proliferation in cell viability assays; Combined treatment of QTX3544 with afatinib led to a deeper suppression of MAPK signaling and enhanced inhibition of KRASG12V-driven cancer cell survival in colony formation assays; Combination treatment of QTX3544 with cetuximab significantly enhanced anti-tumor efficacy and elicited greater tumor regressions in pancreatic and colorectal KRASG12V-mutant cell line-derived xenograft models, as well as in a patient-derived colorectal tumor xenograft model."

Late-breaking abstract • Preclinical • Solid Tumor

Quanta Therapeutics Announces Late-Breaking Presentation of QTX3544, an Oral G12V-Preferring Multi-KRAS Inhibitor, at AACR Annual Meeting 2025 (GlobeNewswire) - "Quanta Therapeutics...announced it will give a late-breaking poster presentation on QTX3544 at the American Association for Cancer Research (AACR) Annual Meeting 2025..."

Late-breaking abstract • Solid Tumor

QTX3544-201: QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations (clinicaltrials.gov) - P1 | N=237 | Recruiting | Sponsor: Quanta Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • 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

QTX3544 in Patients with Advanced Solid Tumors with KRAS G12V Mutations (clinicaltrials.gov) - P1 | N=237 | Not yet recruiting | Sponsor: Quanta Therapeutics

Metastases • New P1 trial • Oncology • 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

Discovery and characterization of QTX3544, a potent, selective, and orally bioavailable allosteric G12V preferring multi KRAS inhibitor (AACR 2024) - "In addition, QTX3544 showed good brain penetration in mice. Taken together, this preclinical characterization supports the advancement of QTX3544 into IND enabling studies for KRASG12V mutant cancers."

Late-breaking abstract • Colorectal Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • BRAF • HRAS • KRAS • NRAS

Quanta Presents Preclinical Data for QTX3544, a Potent and Selective G12V-preferring Multi-KRAS Inhibitor, in Late-Breaking Session at Annual AACR Meeting 2024 (GlobeNewswire) - "Quanta Therapeutics...announced the presentation of QTX3544, a multi-KRAS inhibitor with G12V-preferring activity (G12V+ multi-KRAS), in a late-breaking poster presentation session at the American Association of Cancer Research (AACR) Annual Meeting...QTX3544 demonstrated a favorable preclinical profile, including high selectivity and potent activity against multiple KRAS mutations with preference for the G12V mutation. Additionally, QTX3544 significantly inhibited KRAS^G12V tumor growth in preclinical animal models and exhibited promising oral bioavailability and pharmacokinetic properties...'We look forward to completing IND-enabling studies for QTX3544 this year to support future clinical studies in patients with G12V-mutated solid tumors, a population without targeted treatment options.'....Favorable oral bioavailability and pharmacokinetic properties in preclinical animal studies."

Late-breaking abstract • PK/PD data • Preclinical • Oncology • Solid Tumor

Quanta Therapeutics Announces Late-Breaking Presentation of QTX3544, a G12V-preferring multi-KRAS inhibitor, at AACR Annual Meeting (GlobeNewswire) - "Quanta Therapeutics...today announced it will give a late-breaking poster presentation of QTX3544 at the American Association for Cancer Research (AACR) Annual Meeting being held April 5-10, 2024, in San Diego, California."

Late-breaking abstract • Preclinical • Oncology

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