RGT-264 / Regor - LARVOL DELTA

RGT-264 a highly potent, selective and orally bioavailable HPK1 (MAP4K1) inhibitor augments immune activation and anti-tumor immunity (EORTC-NCI-AACR 2024) - P1 | "RGT-264, a highly potent and selective HPK1 inhibitor, provides an opportunity as a small molecule immunotherapy to boost anti-tumor immunity either as monotherapy or in combination with immune checkpoint inhibitors. The preclinical data support the advancement of RGT-264 into clinical development. Phase I single agent dose escalation clinical trial of RGT-264 (NCT05764915) has been completed."

IO biomarker • Oncology • BLNK • LCP2

First-in-human phase 1 study of RGT-264, a potent hematopoietic progenitor kinase 1 (HPK1) inhibitor in patients (pts) with advanced solid tumors (EORTC-NCI-AACR 2024) - P1 | "RGT-264 showed dose-dependent target suppression and demonstrated significant target engagement in the 50-mg cohort pts. Further investigation of RGT-264 in combination with immunotherapy agents is planned."

Clinical • Metastases • P1 data • Biliary Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Melanoma • Nasopharyngeal Carcinoma • Oncology • Pancreatic Cancer • Prostate Cancer • Rectal Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Vaginal Cancer • LCP2

A Phase I Study of RGT-264 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=11 | Terminated | Sponsor: Regor Pharmaceuticals Inc. | N=56 ➔ 11 | Trial completion date: Aug 2025 ➔ Feb 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2025 ➔ Feb 2024; Due to the change in study plan and not due to safety reasons

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

A Phase I Study of RGT-264 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: Regor Pharmaceuticals Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Solid Tumor

A Phase I Study of RGT-264 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Regor Pharmaceuticals Inc.

Metastases • New P1 trial • Oncology • Solid Tumor