CCI-001 / PharmaMatrix Holdings - LARVOL DELTA

PMH-001: A first-in-human phase I study of the novel microtubule disruptor CCI-001 in patients with advanced cancer. (ASCO 2026) - P1 | "Funded by PharmaMatrix Holdings Ltd Clinical Trial Registration Number: NCT04823897 Background: CCI-001 is a thiocolchicine derivative, ßIII tubulin-selective microtubule disruptor being studied in the first in human PMH-001 Phase I trial as monotherapy (dose-escalation, -expansion) and in combination with carboplatin and gemcitabine...Of response-evaluable pts, the overall response rate (ORR) was 1 of 23 or 4.3% (partial response, squamous cell carcinoma of the lung, 7.5 mg/m2, who previously failed paclitaxel)... The RPIID of single agent CCI-001 is 6.75 mg/m2. CCI-001 was well tolerated at all dose levels tested, with AEs typical for a drug of this class. Peripheral neuropathy was rare (3 Gr 1 AEs, 2 related)."

Clinical • First-in-human • Metastases • P1 data • Lung Cancer • Neutropenia • Oncology • Solid Tumor • Squamous Cell Carcinoma

A Phase I Open-Label, Single-Arm, Dose-Escalation Clinical and Pharmacology Study of CCI-001 as Monotherapy and in Combination With Standard Chemotherapy in Patients With Recurrent and/or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: PharmaMatrix Holdings Ltd | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2026 ➔ Dec 2027

First-in-human • Monotherapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Study of CCI-001 in Patients With Recurrent and/or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: PharmaMatrix Holdings Ltd | Trial completion date: May 2025 ➔ Dec 2026 | Trial primary completion date: May 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Study of CCI-001 in Patients With Recurrent and/or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: PharmaMatrix Holdings Ltd | Trial completion date: May 2023 ➔ May 2025 | Trial primary completion date: May 2023 ➔ May 2025

Metastases • Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor