Ovarian Cancer Clinical Trial

A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors

Summary

The primary objective of the study is to estimate the antitumor efficacy of SOT101 in combination with pembrolizumab in selected tumors.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants with the following histologically or cytologically confirmed solid tumor indications and line of treatment:

Non-small cell lung cancer (NSCLC).
Colorectal cancer.
Cutaneous squamous cell carcinoma (cSCC).
Advanced hepatocellular carcinoma (not applicable in France).
mCRPC.
Ovarian cancer.
Have measurable disease per RECIST 1.1. mCRPC participants with no measurable disease and only widespread bone disease must have a CTC count of ≥5 cells per 7.5 mL of blood.
Availability of tumor tissue from a fresh biopsy at screening unless the biopsy cannot be obtained due to safety reasons or non-accessibility of the tumor site. If it is not possible to obtain a fresh biopsy, every effort should be taken to retrieve an archival biopsy. Archived, fixed tumor tissue may only be collected if taken preferentially after completion of the most recent systemic tumor therapy and within 12 months prior to the first dose of study treatment.
Eastern Cooperative Oncology Group (ECOG) score 0-1.
Have recovered from all AEs (except alopecia) due to previous therapies to grade ≤1 (excluding alopecia) or have stable grade 2 neuropathy.

Have adequate organ function as defined below:

Hematology:

Absolute neutrophil count ≥1500/μL.
Platelets ≥100 000/μL.
Hemoglobin ≥9.0 g/dL .
Renal function: Creatinine clearance as measured by glomerular filtration rate ≥30 mL/min using Cockcroft-Gault equation.
Hepatic function: Alanine transaminase (ALT)/aspartate transaminase (AST) ≤2.5× upper limit of normal (ULN) and total bilirubin ≤1.5×ULN or direct bilirubin ≤ ULN in participants without liver metastasis. In participants with liver metastasis, ALT/AST ≤5×ULN is allowed but total bilirubin must be ≤2×ULN.
Prothrombin time and activated partial thromboplastin time ≤1.5×ULN.
Participants must not have active hepatitis B or hepatitis C infection.
Adequate contraception must be applied in all women of childbearing potential (WOCBP) and in male participants.

Exclusion Criteria:

Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a grade ≥3 AE.
Prior exposure to agonists of interleukin (IL)-2 or IL-15.

Prior systemic anti-cancer therapies, including investigational agents:

Less than 4 weeks for systemic chemotherapy and immuno-oncology therapies; and for tyrosine kinase inhibitors 4 weeks or 5 half-lives (whichever is shorter).
Less than 4 weeks from major surgeries and not recovered adequately.
Has received prior radiotherapy within 2 weeks of the start of study interventions or have had a history of radiation pneumonitis.
NSCLC indication only: Received radiation therapy to the lung >30 Gy within 6 months.
Has received a live or live-attenuated vaccine within 30 days.

Clinically significant cardiac abnormalities including prior history of any of the following:

Cardiomyopathy, with left ventricular ejection fraction ≤ 50%.
Congestive heart failure of New York Heart Association grade ≥2.
History of clinically significant artery or coronary heart disease.
Prolongation of QTcF >450 msec .
Clinically significant cardiac arrythmia that cannot be controlled with adequate medication.
Uncontrolled hypertension defined as systolic blood pressure >160 mmHg, diastolic blood pressure >110 mmHg.
Prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
Prior allogeneic tissue/solid organ transplant.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy.
History of or serology positive for human immunodeficiency virus (HIV).
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ that have undergone potentially curative therapy are not excluded.
Has known active central nervous system metastases and/or carcinomatous meningitis, unless stable.
Had severe hypersensitivity (grade ≥3) to pembrolizumab and/or any of its excipients.
Has an active autoimmune disease that has required systemic treatment in the past 2 years.
History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic therapy.
Has any condition that might confound the results of the study or interfere with the participant's participation for the full duration of the study.

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

166

Study ID:

NCT05256381

Recruitment Status:

Active, not recruiting

Sponsor:

SOTIO Biotech AG

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There are 48 Locations for this study

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Innovative Clinical Research Institute
Whittier California, 90603, United States
University of Pittsburg Medical Center (UPMC) Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Institut Jules Bordet
Anderlecht , 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium
Grand Hospital de Charleroi
Charleroi , 6000, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven , 3000, Belgium
Centre Hospitalier Universitaire de Liège
Liège , 4000, Belgium
Masarykuv Onkologicky Ustav
Brno , 656 5, Czechia
Nemocnice Hořovice
Hořovice , 268 3, Czechia
Fakultní nemocnice Olomouc
Olomouc , 77900, Czechia
Hôpital Ambroise-Paré
Boulogne-Billancourt , 92100, France
Merchant Logo Institute Bergonié
Bourdeaux , 33000, France
Centre de Lutte Contre le Cancer
Caen , 14076, France
Hospital del la Timone
Marseille , 13005, France
Centre Hospitalier Universitaire de Nantes
Nantes , 44093, France
Centre Antoine Lacassagne
Nice , 06189, France
Hospital L'archet
Nice , 06202, France
Hôpital Foch
Suresnes , 92150, France
Institute Claudius Regaud
Toulouse , 31059, France
Gustave Roussy
Villejuif , 94805, France
High Technology Hospital MedCenter Ltd - Batumi
Batumi , 6000, Georgia
Evex Hospitals- Kutaisi Referral
Kutaisi , 4600, Georgia
LLC Todua Clinic
Tbilisi , 0112, Georgia
Evex Hospitals - Caraps Medline
Tbilisi , 0159, Georgia
New Vision University Hospital
Tbilisi , 0159, Georgia
Tbilisi Institute of Medicine
Tbilisi , 0160, Georgia
Jerarsi Clinic
Tbilisi , 0167, Georgia
Consilium Medulla Multiprofile Clinic
Tbilisi , 0186, Georgia
Evex Hospitals - Caucasus Medical Center
Tbilisi , 0186, Georgia
Észak-Pesti Centrumkórház - Honvédkórház
Budapest , 1134, Hungary
Petz Aladár Egyetemi Oktató Kórház - Győr
Győr , 9023, Hungary
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
Brescia , 25123, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola , 47014, Italy
Instituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli , 80131, Italy
Ospedale Guglielmo da Saliceto
Piacenza , 29121, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome , 00168, Italy
Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte
Siena , 53100, Italy
Ospedale Civile di Sondrio
Sondrio , 23100, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona , 37134, Italy
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznań Wielkopolskie, 60-78, Poland
Pratia Poznań
Skorzewo , 60-18, Poland
MTZ Clinical Research powered by Pratia
Warszawa , 02-17, Poland
Hospital Teresa Herrera - Materno Infantil
A Coruña , 15006, Spain
Hospital Germans Trias i Pujol
Badalona , 08916, Spain
Hospital Universitari Vall d'Hebrón
Barcelona , 08035, Spain
Institut Catala d'Oncologia
Barcelona , 08908, Spain
Clinica Universidad de Navarra - Pamplona
Madrid , 28027, Spain
Clínica Universidad de Navarra - Madrid
Madrid , 28027, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid , 28222, Spain
Hospital Clínico Universitario de Valencia
Valencia , 46010, Spain

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

166

Study ID:

NCT05256381

Recruitment Status:

Active, not recruiting

Sponsor:


SOTIO Biotech AG

How clear is this clinincal trial information?

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