Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Small Cell Lung Carcinoma

Breast Neoplasms

Adenocarcinoma

Triple Negative Breast Neoplasms

Melanoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Transitional Cell

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Carcinoma, Renal Cell

Neoplasm Metastasis

Lung Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Neoplasms, Second Primary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms, Squamous Cell

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Kidney Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Head and Neck Neoplasms

Neoplastic Processes

Small Cell Lung Cancer

Ovarian Cancer

Transitional Cell Carcinoma

Renal Cell Carcinoma

Ovarian Epithelial Cancer

Clear Cell Renal Cell Carcinoma

Papillary Renal Cell Carcinoma

Chromophil Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antibodies

Antibodies, Monoclonal

Immune Checkpoint Inhibitors

Immunoglobulins

Antineoplastic Agents, Immunological

Escalating repeated doses of JK08 administered as a subcutaneous injection. A cycle of treatment is defined as 21 days, in which three doses of JK08 will be planned for administration.

JK08 administered at the maximum-tolerated dose/recommended Phase 2 dose as a subcutaneous injection in patients with a mix of solid tumors. Pembrolizumab will be given IV per standard institutional practice

Recombinant fusion protein consisting of two functional elements, which are a fully human monoclonal antibody, directed against CTLA-4 and a protein complex formed by the human IL-15 and the Sushi domain of human IL-15Rα.

JK08

Naimish Pandya, MD

Nuria Kotecki, MD

Hans Prenen, MD

Sylvie Rottey, MD

Lionel D'Hondt, MD

Omar Saavedra, MD

Elena Garralda, MD

Valentina Boni, MD

Maria de Miguel, MD

Guillermo De Velasco, MD

Valentina Gambardella, MD

This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of subcutaneously administered JK08 in patients with unresectable locally, advanced or metastatic cancer.

This Phase 1/2, open label, dose escalation and cohort expansion study is designed to evaluate and characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor activity of JK08 administered subcutaneously (SC) on a once weekly (QW) schedule in patients with unresectable locally, advanced or metastatic cancer.

The study consists of a Dose Escalation phase to determine the MTD/OBD of JK08, followed by a Cohort Expansion phase to further define the safety and initial efficacy of JK08 monotherapy or in combinations.

Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer

A Phase 1/2, Multicenter, Open Label, Dose Escalation & Dose Expansion Study of JK08, an IL-15 Antibody Fusion Protein Targeting CTLA-4, Monotherapy or in Combination in Patients With Unresectable Locally Advanced or Metastatic Cancer

The incidence of DLTs during the DLT assessment period.

Determination of the maximum-tolerated dose/recommended Phase 2 dose.

Incidence, nature, and severity of treatment-emergent adverse events \[TEAEs\]. Defined as any AE that occurs during the treatment period (i.e., after any treatment) and up to 28 days after the last dose of study treatment.

Incidence, nature, and severity of Serious Adverse Events \[SAEs\].

Incidence, nature, and severity of adverse events \[AEs\].

The percentage of patients with a complete response, partial response, or stable disease for at least 2 consecutive tumor assessments.

Time from the date of initiation of study therapy to the date measurement criteria are first met for progressive disease or death from any cause, whichever occurs first.

Time from the date of initiation of study therapy to the date of death from any cause.

Salubris Biotherapeutics Inc

Wounds and Injuries

Behaviors and Mental Disorders

Skin Neoplasms

Hyperthermia

Carcinoma, Basal Cell

Fever

Neoplasms, Basal Cell

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

The study arm in which hyperthermia and radiotherapy are administered. The RT Dose: 6 fractions of 5 Gy each, delivered twice per week and with a minimum interval of 48 hours, preferably 72 hours, between each fraction over three weeks.

The study arm in which only radiotherapy is administered. RT Dose: 12 fractions of 4 Gy each, delivered 3 times per week, with sessions scheduled every other day (exceptions can be made in weeks with holidays) over four weeks.

The wIRA device applies hyperthermia by heating the treatment area (with maximum surface temperature set to 43° C), aiming to make cancer cells more sensitive to radiation therapy for non-melanoma skin cancer combined with radiotherapy.

Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined

Radiotherapy (RT)

Nidar Batifi, MSc

Daniel Zwahlen, MD

Winfried Arnold, MD

Maximilian Sturz, MD

Arnold Winfried, MD

The SAHARA trial assesses wether combining ultrahypofractionated accelerated radiotherapy (RT) with hyperthermia is as effective as standard hypofractionated high-dose radiation in treating non-melanoma skin cancer (NMSC).

The SAHARA Trial is investigating if adding hyperthermia to radiotherapy (RT) can enhance treatment outcomes by making cancer cells more sensitive to radiation, thus requiring lower doses and potentially reducing side effects. The trial compares high-dose RT alone with de-escalated RT plus hyperthermia. The aim is to demonstrate that the combination is non-inferior to standard RT in treating non-melanoma skin cancer (NMSC). The trial is designed for elderly people of 65 years or older.

Skin Cancer and Hyperthermia and Radiotherapy

Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial

The primary outcome is local control, defined as the absence of of recurrence or need for subsequent intervention.

Radiation is applied assessed immediately post-treatment, at six weeks, and three months post-treatment using Common Terminology Criteria for Adverse events (CTCAE 5.0).

Monitoring late toxicities, specifically noted at six months, one year, and two years after completion of treatment using Common Terminology Criteria for Adverse events (CTCAE 5.0).

Evaluations are carried out at time of inclusion, immediately post-treatment, at three months, 6months, one year and two years post-treatment utilizing the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Elderly (QLQ-ELD14) questionnaire.

Luzerner Kantonsspital

Kantonsspital Winterthur KSW

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer	NCT05620134	Cancer Tumor, Solid Advanced Solid ... Metastatic Canc... Melanoma Colorectal Canc... Non-small Cell ... Small-cell Lung... Urothelial Carc... Squamous Cell C... Luminal Breast ... Triple Negative... Clear Cell Rena... Papillary Renal... Gastric Adenoca... GastroEsophagea... Squamous Cell C... Pancreatic Aden... Hepatocellular ... Colorectal Aden... Epithelial Ovar... Thyroid Cancer	JK08 Pembrolizumab	18 Years -	Salubris Biotherapeutics Inc
Skin Cancer and Hyperthermia and Radiotherapy	NCT06384053	Basal Cell Carc... Squamous Cell C... Non-melanoma Sk...	Water-filtered ... Radiotherapy (R...	65 Years -	Kantonsspital Winterthur KSW

Spots Global Cancer Trial Database for squamous cell carcinoma skin