A study to evaluate safety and efficacy of SOT101 in combination with pembrolizumab in patients with selected advanced/refractory solid tumors

Phase 1

• Conditions: advanced/refractory solid tumors; MedDRA version: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; MedDRA version: 24.1Level: LLTClassification code 10085908Term: Cutaneous squamous cell carcinomaSystem Organ Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code 10019829Term: Hepatocellular carcinoma recurrentSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-005774-25-BE
• Lead Sponsor: SOTIO Biotech AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-29
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1.Be 18 years of age on the day of signing informed consent
2.Ability to understand and sign written informed consent to participate in the study
3.Provides written informed consent for the study
4.Patients with the following histologically or cytologically confirmed solid tumor indications and line of treatment:NSCLC;Colorectal cancer;cSCC;Advanced hepatocellular carcinoma;mCRPC;Ovarian cancer
5.Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology; lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
mCRPC: Patients with both measurable and non-measurable disease will be enrolled. At least 35 patients with measurable disease will be enrolled. Patients with no measurable disease and only widespread bone disease must have a CTC count of =5 cells per 7.5 mL of blood.
6.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.
7.Performance status: Eastern Cooperative Oncology Group (ECOG) performance score 0-1
8.Must have recovered from all AEs (except alopecia) due to previous therapies to grade =1 toxicity (excluding alopecia) or have stable grade 2 neuropathy
Have adequate organ function as defined below. Specimens must be collected within 10 days prior to the start of study interventions.
9.Hematology:
9.1.Absolute neutrophil count =1500/µL
9.2.Platelets =100 000/µL
9.3.Hemoglobin =9.0 g/dL (criteria must be met without packed red blood cell transfusion within the prior 2 weeks; patients can be on a stable dose of erythropoietin [= 3 months])
10.Renal function: Creatinine clearance as measured by glomerular filtration rate =30 mL/min using Cockcroft-Gault equation
11.Hepatic function: ALT/AST =2.5× upper limit of normal (ULN) and total bilirubin =1.5×ULN or direct bilirubin = ULN in patients without liver metastasis (benign hereditary hyperbilirubinemias). In patients with liver metastasis, ALT/AST =5×ULN is allowed but total bilirubin must be =2×ULN.
12.Prothrombin time and activated partial thromboplastin time =1.5×ULN
13.A locally performed hepatitis B (HBV) test is required during screening.Patients who are hepatitis B (HBV) surface antigen positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load before study entry (ICF signature).
14.A locally performed hepatitis C (HCV) test is required during screening. Patients with history of HCV infection are eligible if HCV viral load is undetectable at screening. Patients must have completed anti-viral therapy at least 4 weeks before study entry (ICF signature).
15.A female patient is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies:
15.1.Not a woman of childbearing potential (WOCBP). A WOCBP is defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no

Exclusion Criteria

1.Has received prior therapy with an anti-PD-1, anti-PD-L1, or 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
2.Prior exposure to drugs that are agonists of IL-2 or IL-15
3.Prior systemic anti-cancer therapies, including investigational agents, before the first dose of study medication (day 1 of cycle 1)
4.Has received prior radiotherapy within 2 weeks of the start of study interventions or have had a history of radiation pneumonitis.
5.NSCLC indication only: Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study interventions
6.Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study interventions
Prior/concurrent clinical study experience
7.Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks or 5 half lives (whichever shorter) before study entry (ICF signature). Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks or 5 half lives (whichever shorter) after the last dose of the previous investigational agent.
8.Clinically significant cardiac abnormalities including prior history of any of the following:
8.1.Cardiomyopathy, with left ventricular ejection fraction =50% at screening
8.2.Congestive heart failure of New York Heart Association grade =2
8.3.History of clinically significant (i.e., active) atherosclerotic cardiovascular disease, specifically myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study interventions, and any clinically significant history of coronary heart disease and clinically significant artery disease within the past 5 years
8.4.Prolongation of QTcF >450 msec
8.5.Clinically significant cardiac arrythmia that cannot be controlled with adequate medication
9.Uncontrolled hypertension defined as systolic blood pressure >160 mmHg, diastolic blood pressure >110 mmHg. Patients with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry (ICF signature).
10.Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. Patients who have had a transplant more than 5 years ago are eligible as long as there are no symptoms of graft versus host disease.
11.Has had an allogeneic tissue/solid organ transplant
12.Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study interventions
13.History of or serology positive for HIV. A locally performed HIV test is required during screening.
14.Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Patients with basal cell carcinoma of the skin or carcinoma in situ excluding carcinoma,in situ) of bladder that have undergone potentially curative therapy are not excluded.
15.Has known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, and without requirement of steroid treatment for at least 14 days prior to the first do

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified