ACTRN12618001955202 : A Phase 1a/1b Safety and Tolerability Study of FPT155 in Patients with Advanced Solid Tumors

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 | Blood / Myeloma / Lymphoma,Bowel (colorectum),Breast,CUP,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAcute Lymphoblastic Lymphoma,Adrenocortical carcinoma,Anus,Basal cell carcinoma,B-Cell Non Hodgkin Lymphoma,Bile duct,Bladder,Bone,Breast,Cancer of Unknown Primary,Cervix,Chondrosarcoma,Colon,Colorectum,Cutaneous Squamous Cell Carcinoma (CSCC),Diffuse Large Cell Lymphoma,Endometrium,Epithelial,Ewing's Sarcoma,Fallopian tube,Follicular Lymphoma,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Germ cell tumour,Head and neck,Hodgkin's Disease (Hodgkin's Lymphoma),Kidney,Leiomyosarcoma,Liposarcoma,Liver,Lung,Lymphoma,Mantle Cell Lymphoma,Melanoma (Ocular),Melanoma (Skin),Merkel cell,Mesothelioma,Non-Small Cell Lung Cancer,Nose (nasopharynx),Oesophagus,Oral cavity,Oropharynx,Osteosarcoma,Ovary,Pancreas,Penis,Peritoneal,Polycythaemia vera,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Sarcoma,Skin Lymphoma,Small Cell Lung Cancer,Soft Tissue Sarcoma,Squamous cell carcinoma ,Stomach,Synovial Sarcoma,T-Cell Lymphoma,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 evaluating the safety and recommended dose of a new intravenous drug (FPT155) in patients with advanced solid cancers (except primary CNS cancers).
 

This trial is treating patients with advanced solid cancers (except primary CNS cancers).

This is a systemic therapy trial.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.

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 1a/1b Safety and Tolerability Study of FPT155 in Patients with Advanced Solid Tumors

Commercial Sponsor

Five Prime Therapeutics, Inc.

Summary

This is an uncontrolled phase 1a/1b dose escalation, exploration and expansion trial. A recommended dose for FPT155 will be identified in the Phase 1a (the dose escalation phase) and will undergo further clinical evaluation in Phase 1b. In Phase 1a, FPT155 will be administered intravenously every three weeks, on the fist day of each 21-day cycle, at 8 different dosing levels (0.07mg, 0.21mg, 0.70mg, 2.1mg, 7.0mg, 21.0mg, 42.0mg and 70.0mg). Patients will be assigned to a dose level based on their order of enrolment and will continue treatment until it is no longer tolerated or their disease has worsened. Key inclusion criteria for patients in Phase 1a only: disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments.

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Cabrini Education and Research Precinct
Malvern
Li Hoon Lai
lihoonlai@cabrini.com.au
(03) 9508 3421

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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