Nervous System Diseases

Gland and Hormone Related Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Eye Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Pituitary Diseases

Melanoma

Neuroendocrine Tumors

Glioma

Retinoblastoma

Sarcoma

Mesothelioma

Mesothelioma, Malignant

Osteosarcoma

Medulloblastoma

Neuroblastoma

Carcinoid Tumor

Rhabdomyosarcoma

Ocular Melanoma

Neuroendocrine Tumor

Soft Tissue Sarcoma

Malignant Mesothelioma

Pancreatic Neuroendocrine Tumor

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Hematinics

Epinephrine

Liver Extracts

Racepinephrine

Epinephryl borate

ENV-101 (taladegib) tablets, 200 mg once-daily in 28-day cycles

ENV-101 (taladegib) tablets, 300 mg once-daily in 28-day cycles

ENV-101 (taladegib)

Paul Frohna, M.D., Ph.D.

This study employs a 2-stage design that aims to evaluate the efficacy and safety of ENV- 101, a potent Hedgehog (Hh) pathway inhibitor, in patients with refractory advanced solid tumors characterized by loss of function (LOF) mutations in the Patched-1 (PTCH1) gene. Stage 1 of this study will enroll approximately 44 patients randomized between two dose levels. As appropriate, Stage 2 of the study will expand enrollment based on the results of Stage 1.

A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations

A Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations

ORR is comprised of Complete Response (CR) and Partial Response (PR), measured by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1), as determined by an independent review (confirmed CR or PR will be defined as a repeat assessment performed no less than 28 days after the criteria for response is first met).

Unacceptable toxicities = non-hematologic AEs \>= Grade 3 in severity, not including alopecia and fatigue.

Best overall response of confirmed CR or PR as determined by the treating Investigator using RECIST 1.1.

CBR = the proportion of patients who achieved CR, PR or stable disease as determined by the treating Investigator using RECIST 1.1.

OS = Number of months from initiation of study medication to the date of death due to any cause or last follow up.

DOR = the number of months from the start of CR or PR, whichever response is recorded first and subsequently confirmed, to the first date that recurrent or progressive disease is documented or death.

PFS = number of months from initiation of study medication to the earlier of disease progression or death due to any cause or last follow up.

Percentage change in inhibition of Gli1, a marker for inhibition of the Hedgehog pathway, in skin biopsies.

Measurement of trough concentration of study medication in blood at Baseline and the end of each 28-day treatment cycle

Endeavor Biomedicines, Inc.

Breast Neoplasms

Glioblastoma

Astrocytoma

Oligodendroglioma

Lung Neoplasms

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neoplasms, Connective and Soft Tissue

Anaplastic Astrocytoma

Neuroepithelioma

16 subjects to be enrolled; Study Drug F-18 RGD-K5 administered for diagnostic PET Imaging to be observed for a maximum of 4 hours, followed by 24 hour follow up

Study Drug F-18 RGD-K5 administered for diagnostic PET Imaging to be observed for a maximum of 4 hours, followed by 24 hour follow up

F-18 RGD-K5

Michael Yu, MD

The purpose of this research study is to get information from volunteers without cancer and patients with cancer who have received a new investigational study agent called, "\[F-18\] RGDK5," to evaluate biodistribution and dosimetry for the study agent and determine F-18 RGD-K5 uptake in angiogenic tumor. the system.

\[F-18\]RGD-K5 is being investigated as a diagnostic radiopharmaceutical for the detection and localization of angiogenesis tissue or lesions supporting the application and role of integrins in anti-angiogenic therapies to benefit patients with cancer and inflammatory diseases.

The primary objectives of this exploratory study are:

* To gain information on biodistribution of \[F-18\]RGD-K5, and to evaluate the PET images with \[F-18\]RGD-K5 for resolution, signal to background ratio and for the detection and localization of angiogenesis tissue. This Exploratory Investigational New Drug (EIND) study is designed to obtain preliminary imaging and fundamental biodistribution, metabolism and safety information to demonstrate early proof of concept. The information collected under this study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management for the subject.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib) in Patients With Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations	NCT05199584	Solid Tumors Wi...	ENV-101 (talade...	18 Years -	Endeavor Biomedicines, Inc.
Exploratory, Phase 0 Study of Positron Emission Tomography (PET) Imaging Agent, F-18 RGD-K5	NCT00743353	Sarcoma Melanoma Lung Cancer Breast Cancer High Grade Glio...	F-18 RGD-K5	18 Days -	Siemens Molecular Imaging

Spots Global Cancer Trial Database for laryngeal

Every month we try and update this database with for laryngeal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for laryngeal

Every month we try and update this database with for laryngeal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for laryngeal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.