APR003 / Apros Therap - LARVOL DELTA

A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions (clinicaltrials.gov) - P1 | N=11 | Terminated | Sponsor: Apros Therapeutics, Inc | Completed ➔ Terminated; Study terminated prematurely due to internal corporate decision

Trial termination • Colorectal Cancer • Hepatology • Oncology • Solid Tumor • MSI

A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions (clinicaltrials.gov) - P1 | N=11 | Completed | Sponsor: Apros Therapeutics, Inc | Recruiting ➔ Completed | N=36 ➔ 11 | Trial completion date: Dec 2023 ➔ Jan 2023 | Trial primary completion date: Oct 2023 ➔ Jan 2023

Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor • MSI

APR003, an oral liver- and GI-targeted TLR7 agonist, elicits a robust type I interferon response in advanced colorectal cancer patients (SITC 2022) - P1 | "Recently, intratumoral TLR agonists (CMP-001, SD-101) have shown promising responses in melanoma as single agents and in combination with checkpoint blockade. The results suggest our tissue-targeted oral TLR7 agonist may have an increased safety window compared to prior (non-targeted) agents of the same class, thereby achieving Proof-of-Drug Design and warrants further investigation. Trial Registration This study is registered on Clinicaltrials.gov: NCT04645797"

Clinical • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor • IL6 • TNFA

Apros Therapeutics to Present Interim Clinical Data from a Phase 1 Study Evaluating APR003 at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting and World Vaccine & Immunotherapy Congress (WVIC) West Coast (Businesswire) - "Apros Therapeutics, Inc....announced that they will present interim pharmacokinetic and pharmacodynamic Phase 1 clinical data for APR003 at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting to be held November 8-12th in Boston, MA. Data will also be presented at the World Vaccine & Immunotherapy Congress, West Coast November 28th - December 1st in San Diego, CA. APR003 is a first-in-class orally-administered gastrointestinal (GI)- and liver-targeted TLR7 agonist and is currently being evaluated in an ongoing Phase 1 dose escalation trial (NCT04645797) in relapsed/refractory colorectal cancer (CRC) patients with hepatic metastasis."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology

A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Apros Therapeutics, Inc; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Apros Therapeutics, Inc

Clinical • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MSI

Apros Therapeutics Announces IND Clearance from U.S. FDA to Initiate the Trial of APR003, an Orally-Administered Gastrointestinal/Liver-Targeted TLR7 Agonist for Treatment of Advanced Colorectal Cancer (CRC) with Malignant Liver Lesions (Businesswire) - "Apros Therapeutics, Inc...announced that its Investigational New Drug (IND) application for a Phase 1 dose escalation trial of APR003, the company’s first-in-class orally-administered gastrointestinal- and liver-targeted TLR7 agonist development candidate, was cleared by the FDA. The Phase 1 trial aims to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and initial anti-tumor activity of APR003 in patients with advanced unresectable CRC with malignant liver lesions."

IND • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology