ACTRN12617001573347 : An open-label, multi-centre Phase Ib study of the safety and tolerability of IV infused PG545 in combination with nivolumab in patients with advanced solid tumours with an expansion cohort in patients with metastatic pancreatic cancer

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Bowel (colorectum),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),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),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,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 trial is assessing the combination of a new intravenous drug (PG545) and an immunotherapy drug (Nivolumab) in patients with advanced solid cancers, as well as patients with metastatic pancreatic cancer.
 

This trial is treating patients with advanced solid cancers or metastatic pancreatic cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • 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 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

An open-label, multi-centre Phase Ib study of the safety and tolerability of IV infused PG545 in combination with nivolumab in patients with advanced solid tumours with an expansion cohort in patients with metastatic pancreatic cancer

Commercial Sponsor

Scientia Clinical Research Limited

Summary

This trial includes a dose escalation and dose expansion stage. In Stage 1 (dose escalation) patients with advanced or metastatic solid tumours will receive PG545 25, 50 or 100 mg once weekly via IV infusion and Nivolumab 240 mg every two weeks via IV infusion. In Stage 2 (dose expansion) patients with metastatic pancreas cancer will receive the recommended PG545 dose, identified through Stage 1, once weekly via IV infusion and Nivolumab 240 mg every two weeks via IV infusion.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Medical Oncology
Prahran
Ms Nikki Cross
n.cross@alfred.org.au
03 9076 3534

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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