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AXA-042-FIH-01 : A Phase 1, first-in-human, open-label, non-randomized, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AXA-042 as monotherapy in subjects with advanced solid tumors

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18-90Age 18-90

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Bowel (colorectum),Brain and spinal cord,Breast,CUP,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAdrenocortical carcinoma,Anus,Basal cell carcinoma,Bile duct,Bladder,Bone,Breast,Cancer of Unknown Primary,Cervix,Chondrosarcoma,Colon,Colorectum,Cutaneous Squamous Cell Carcinoma (CSCC),Endometrium,Epithelial,Ewing's Sarcoma,Fallopian tube,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastrointestinal stromal tumors (GISTs),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Germ cell tumour,Head and neck,Kidney,Leiomyosarcoma,Liposarcoma,Liver,Lung,Melanoma (Ocular),Melanoma (Skin),Merkel cell,Mesothelioma,Mouth (including tonsil, tongue, soft palate, cheeks, lips, gum),Neuroblastoma,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,Squamous cell carcinoma ,Stomach,Synovial Sarcoma,Testis,Throat (hypopharynx),Thyroid,Urinary tract,Urothelial,Uterus,Vagina,Voice box (larynx),Vulva,Wilm's tumour

Trial Overview Read MoreRead more

This phase I study is evaluating how safe, tolerable and effective a new drug (AXA-042) is in people with advanced or metastatic solid cancers, excluding brain and blood cancers.
 

This trial is treating patients with advanced or metastatic solid cancers, excluding brain and blood cancers.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.
  • 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, first-in-human, open-label, non-randomized, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AXA-042 as monotherapy in subjects with advanced solid tumors

Commercial Sponsor

Axelia Oncology Pty Ltd

Summary

This is a dose-escalation and dose-expansion study. AXA-042 will be administered as an intravenous infusion over 30 minutes on Day 1 of each 21-Day Treatment Cycle under supervised administration. The starting dose is proposed to be 0.0001 mg/kg (7 µg for a 70 kg human) of AXA-042. Subsequent dose levels are planned to be calculated as up to a 3-fold increase over the previous dose levels. Approximately 12-18 people are planned to be enrolled in 5-6 sequential dose levels in the study. Additional participations may be enrolled in further dose levels based on emerging data from this study.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Nathan Reader Wilson
PCCTU.EDD@petermac.org

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.

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