Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Behaviors and Mental Disorders

Urinary Bladder Neoplasms

Hyperthermia

Urologic Neoplasms

Fever

Urologic Diseases

Urinary Bladder Diseases

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Antineoplastic Agents

All Drugs and Chemicals

Mitomycins

Mitomycin

BCG Vaccine

Vaccines

Adjuvants, Immunologic

Immunologic Factors

Synergo radiofrequency (RF)-Induced hyperthermia-chemotherapy (SHTC) with mitomycin C (RITE) intravesical therapy as first-line adjuvant treatment for intermediate and high-risk NMIBC,

Intravesical BCG therapy as first-line adjuvant treatment for intermediate and high-risk NMIBC,

Synergo radiofrequency (RF)-Induced hyperthermia-chemotherapy with mitomycin C (RITE). Intravesical instillation of MMC utilizing the Synergo system.

Synergo + MMC

Bacillus Calmette-Guérin

Igal Ruvinsky, PhD

Gerson Luedecke, Dr. med.

A multi-institutional, prospective, randomised, open-label, superiority, comparative, active-controlled, phase 3 study. The study will compare Synergo RF-induced hyperthermia-chemotherapy (SHTC) plus mitomycin C (MMC) to standard treatment of bacillus Calmette-Guérin (BCG) therapy as first-line adjuvant treatment for intermediate and high-risk NMIBC, and will evaluate recurrence and progression rate over two years of follow-up.

SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I

A Multi-Centre, Randomised, Open-Label Active-Controlled Study Comparing Safety and Efficacy of Synergo Radiofrequency (RF)-Induced Hyperthermia-Chemotherapy With Mitomycin C (RITE) Versus Bacillus Calmette-Guérin (BCG) as First-Line Treatment of Non-Muscle Invasive Papillary Bladder Cancer (NMIBC)

The recurrence-free survival time in patients with NMIBC following treatment with SHTC (investigational arm) compared to BCG (controlled arm).

Safety (rate of adverse events), as well as tolerability of SHTC compared to BCG in terms of the frequency, severity and nature of adverse events and the treatment received.

Proportion of treatment discontinuation of SHTC compared to BCG

Medical Enterprises Europe B.V.

Digestive System Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Pancreatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Pancreatic Cancer

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Gemcitabine

Pembrolizumab

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Immunomodulating Agents

Adenosine

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

TTX-030 plus budigalimab (selected tumors evaluated in expansion)

TTX-030 plus budigalimab plus nab-paclitaxel + gemcitabine

TTX-030 plus nab-paclitaxel + gemcitabine

TTX-030, budigalimab and mFOLFOX6

TTX-030, budigalimab and docetaxel

TTX-030 and mFOLFOX6

TTX-030 and budigalimab

TTX-030, budigalimab, nab-paclitaxel and gemcitabine

TTX-030 and pembrolizumab

TTX-030, nab-paclitaxel and gemcitabine

Budigalimab and mFOLFOX6

This is a phase 1/1b study of TTX-030 in combination therapy, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response.

This trial will study the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TTX-030 in combination with immunotherapy and/or standard chemotherapies.

TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Pembrolizumab or Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.

ORR is defined as the proportion of subjects with CR or PR

DoR will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

DCR is defined as the proportion of subjects with CR, PR, or SD

PFS is measured from documentation of progression or death from any cause, whichever occurs first

Serum concentrations of TTX-030 will be tabulated

AbbVie

Trishula Therapeutics, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I	NCT02254915	Urinary Bladder... Urologic Neopla... Urogenital Neop... Neoplasms Neoplasms by Si... Urinary Bladder... Urologic Diseas...	Synergo + MMC Bacillus Calmet...	18 Years -	Medical Enterprises Europe B.V.
TTX-030 in Combination With Immunotherapy and/or Chemotherapy in Subjects With Advanced Cancers	NCT04306900	Solid Tumor, Ad...	TTX-030, budiga... TTX-030, budiga... TTX-030 and mFO... TTX-030 and bud... TTX-030, budiga... TTX-030 and pem... TTX-030, nab-pa... Budigalimab and...	18 Years - 110 Years	Trishula Therapeutics, Inc.
SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I	NCT02254915	Urinary Bladder... Urologic Neopla... Urogenital Neop... Neoplasms Neoplasms by Si... Urinary Bladder... Urologic Diseas...	Synergo + MMC Bacillus Calmet...	18 Years -	Medical Enterprises Europe B.V.

Spots Global Cancer Trial Database for urothelial cell cancer