PRO-001 Clinical Study

Phase I dose-escalation study in patients with advanced solid tumours

  • All patients had metastatic spread & rapidly progressing disease
  • Exhausted all other therapeutic options
  • OBJECTIVE: Recommended Phase II dose
PRO-001 study image of lady
Demographic Overall Study
Patients 68
Evaluable Patients (≥ 2 cycles) 49
Primary cancer types 19
Age 56
(range 20-83)
Prior chemotherapy regimens 2.7
(range 1-8)


In this completed Phase I study, 68 patients with advanced solid tumours and metastatic disease that had previously been treated with other systemic anti-cancer therapies received Acelarin as monotherapy at doses ranging from 375 mg/m2 to 1,000 mg/m2. Initial signs of efficacy were evaluated using the standard scoring system known as Response Evaluation Criteria In Solid Tumours, or RECIST.

A subset of 49 patients received two or more cycles of Acelarin, equivalent to two or more months of therapy, and had at least one follow-up radiographic assessment to measure changes in tumour size. Of these patients, five achieved a partial response, with at least a 30% decrease in tumour size, although not all of these five patients received a final confirmatory scan as technically required by the RECIST criteria for classification as a partial response. Another 33 patients had tumours that either decreased by up to 30% or increased by less than 20% and were scored as having stable disease. This resulted in an overall disease control rate, the combination of both partial response and stable disease, of 78% in the total 49-patient evaluable population.

Best Overall Response Rate

Acelarin 217 higher graph