M7824 : A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability,Pharmacokinetics, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18 - 75Age 18 - 75

Advanced CancersCancer LocationMulti-Cancer
Trial

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,Melanoma (Skin),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,Glioblastoma (GBM),Glioma,Kidney,Leiomyosarcoma,Liposarcoma,Liver,Medullablastoma,Melanoma (Skin),Meningioma,Merkel cell,Mesothelioma,Mouth (including tonsil, tongue, soft palate, cheeks, lips, gum),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,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,Cutaneous Squamous Cell Carcinoma (CSCC),Stomach,Synovial Sarcoma,Testis,Throat (hypopharynx),Thyroid,Urothelial,Urothelial,Uterus,Melanoma (Ocular),Vagina,Voice box (larynx),Vulva,Gastro-oesophageal junction ,Urinary tract

Trial Overview Read MoreRead more

This phase I trial is assessing a new drug known as M7824, given to patients with a solid cancer (not blood) every two weeks.
 

This trial is treating multiple types of cancer including solid cancers (excluding blood).

This is a systemic therapy trial.

You may be excluded from this trial if:

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

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 I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability,Pharmacokinetics, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

Commercial Sponsor

Merck

Summary

This is a Phase I, open-label, dose-escalation trial with consecutive parallel-group expansion in selected solid tumor indications. The current trial is composed of a standard dose escalation "3 + 3" cohort design, for which 3 to 6 subjects will be enrolled at each dose level depending on the occurrence of dose limiting toxicities (DLTs), followed by a consecutive parallel-group expansion in selected solid tumor indications. Cohorts of 3 subjects with metastatic or locally advanced solid tumors, for which no standard effective therapy exists or standard therapy has failed, will receive MSB0011359C (M7824) at escalating dose levels. After determination of the Maximum tolerated dose (MTD), enrollment in several expansion cohorts will be opened to determine the safety, pharmacokinetic (PK) / Pharmacodynamic, and clinical activity of MSB0011359C (M7824). Subjects who have experienced a confirmed complete response (CR) should continue treatment through the end of 12 months, although additional treatment is possible. In the case of progressive disease (PD), subjects should continue treatment through their next tumor assessment. Additional indications will be planned based on emerging data in the field.

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Kate Rooney
krooney@bordermedonc.com.au
02 6064 1503

Cabrini Hospital
Malvern
Nina Box
nbox@cabrini.com.au
(03) 9508 3421