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SURF301 : A Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy,Treatment | Blood / Myeloma / Lymphoma,Bowel (colorectum),Brain and spinal cord,Breast,CUP,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAcute Lymphoblastic Lymphoma,Adrenocortical carcinoma,Anus,Astrocytoma,Basal cell carcinoma,B-Cell Non Hodgkin Lymphoma,Bile duct,Bladder,Bone,Brain,Brain stem,Breast,Cancer of Unknown Primary,Central Nervous System,Cervix,Chondrosarcoma,Colon,Colorectum,Cutaneous Squamous Cell Carcinoma (CSCC),Diffuse Large Cell Lymphoma,Endometrium,Ependymomas,Epithelial,Ewing's Sarcoma,Fallopian tube,Follicular Lymphoma,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastrointestinal stromal tumors (GISTs),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Germ cell tumour,Glioblastoma (GBM) ,Glioma,Head and neck,Hodgkin's Disease (Hodgkin's Lymphoma),Kidney,Langerhans Cell Histiocytosis,Leiomyosarcoma,Liposarcoma,Liver,Lung,Lymphoma,Mantle Cell Lymphoma,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,Paroxysmal Nocturnal Hemoglobinuria (PNH),Penis,Peritoneal,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Sarcoma,Skin Lymphoma,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,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/II study is evaluating how safe, tolerable and effective a new drug (TYRA-300) is in people certain cancers with FGFR3 activating gene alterations.
 

This trial is treating patients with cancers with FGFR3 activating gene alterations, including locally advanced or metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid cancers.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • 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.

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 Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)

Commercial Sponsor

Tyra Biosciences, Inc

Summary

This trial is investigating TYRA-300, a new FGFR3-selective tyrosine kinase inhibitor, in cancers with FGFR3 activating gene alterations including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid cancers. Phase 1 is a dose-escalation study, with two parts. In Part A (dose-escalation), participants will receive TYRA-300 (taken once daily by mouth in 28-day cycles) in increasing doses, starting at 10mg daily. In Part B (dose-expansion), participants will receive TYRA-300 (orally, once daily in 28-day cycles) to continue to study the safety and effect at certain doses. In Phase 2, participants will receive TYRA-3000 (orally, once daily in 28-day cycles) at the recommended doses determined during Phase 1.

Recruiting Hospitals Read MoreRead more

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Richelle Linklater
PCCTU.MoncA@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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