ACT001 : A phase 1 dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of ACT001 in patients with advanced solid tumors

Male or<br/>FemaleGender Male or

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer

Systemic therapy | Bowel (colorectum),Brain and spinal cord,Breast,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAnus,Astrocytoma,Basal cell carcinoma,Bile duct,Bladder,Bone,Brain,Brain stem,Breast,Cervix,Chondrosarcoma,Colon,Colorectum,Cutaneous Squamous Cell Carcinoma (CSCC),Endometrium,Ependymomas,Epithelial,Ewing's Sarcoma,Fallopian tube,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Glioma,Kidney,Leiomyosarcoma,Liposarcoma,Liver,Medullablastoma,Melanoma (Ocular),Melanoma (Skin),Meningioma,Merkel cell,Mesothelioma,Neuroblastoma,Neuroendocrine tumours,Non-Small Cell Lung Cancer,Nose (nasopharynx),Oesophagus,Oral cavity,Oropharynx,Osteosarcoma,Ovary,Pancreas,Penis,Peritoneal,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Sarcoma,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,Stomach,Synovial Sarcoma,Testis,Throat (hypopharynx),Thyroid,Urinary tract,Urothelial,Uterus,Vagina,Voice box (larynx),Vulva

Trial Overview Read MoreRead more

This phase I trial is evaluating the study drug ACT001 in patients with advanced (solid) cancers.

This trial is treating patients with advanced cancers (excluding blood cancer).

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A phase 1 dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of ACT001 in patients with advanced solid tumors

Commercial Sponsor

Accendatech AU Pty Ltd


The primary purpose of this study is to evaluate the safety of a new cancer drug, ACT001 which has not yet been tested in humans. The study will also look at the amount of drug in the blood to evaluate the way the body processes the drug and the way the drug acts on the growth of tumours in cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been diagnosed with advanced or metastatic solid tumor, including glioblastoma, with no standard treatment options. Study details All participants in this study will receive a specified dose of ACT001 each day for 56 days (two 28 day cycles). The first set of participants will start on the lowest dose level, with the next highest dose only commencing in the next set of participants once the safety of the first dose has been confirmed. Researchers will take a number of blood samples on days 1, 2, 3, 17, 18 and 29 of dosing in each participant to examine the rate that the body processes the drug. Further blood samples, as well as CT and MRI scans will be taken before treatment and at the end of treatment to look for changes in tumour growth. Participants will also be assessed for side effects throughout the study period. It is hoped that the findings of this trial will show whether ACT001 can be safely given to cancer patients, and provide information on the rate of processing of the drug in the body. Using this information, researchers hope to find the best dose to use for further testing of ACT001 in cancer patients.

Recruiting Hospitals Read MoreRead more

Epworth Hospital
Mr Dave McKee
03 9936 8043

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.