advanced/refractory solid tumors MedDRA version: 21.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864 MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864 MedDRA version: 24.1 Level: LLT Classification code 10085908 Term: Cutaneous squamous cell carcinoma System Organ Class: 100000004864 MedDRA version: 21.0 Level: LLT Classification code 10019829 Term: He
Conditions
Interventions
Product Name: SO-C101
Product Code: SO-C101
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RECOMBINANT HIL15-SUSHI+ FUSION PROTEIN
CAS Number: 1416390-27-6
Current Sponsor code: SOT1
Sponsors
SOTIO Biotech AG
Eligibility
Sex/Gender
All
Inclusion criteria
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.Accessible tumor tissue available for fresh biopsy except for mCRPC with no accessible tumor tissue 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: Alanine transaminase (ALT)/aspartate transaminase (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.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.Patients with history of hepatitis C (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 menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient. 15.2.A WOCBP who agrees to use a highly effective contraceptive method
Exclusion criteria
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 study entry (ICF signature): 3.1. 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) 3.2. Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery 4.Has received prior radiotherapy within 2 weeks of the start of study interventions. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-central nervous system disease. 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, atherosclerotic cardiovascular disease, specifically myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study interventions, and any history of coronary heart disease and clinically significant peripheral and/or carotid artery disease 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. 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 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 that have undergone potentially curative therapy are not excluded. 15.Has known active central nervous system metastases and/or carcin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the antitumor efficacy of SOT101 in combination with pembrolizumab;Secondary Objective: To assess the safety and tolerability of SOT101 in combination with pembrolizumab according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. To further evaluate the antitumor efficacy of SOT101 in combination with pembrolizumab. (Population) pharmacokinetics (PK) of SOT101 in combination with pembrolizumab.To determine the immunogenicity of SOT101 in combination with pembrolizumab;Primary end point(s): •Objective response rate (ORR) according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) in patients with measurable disease;Timepoint(s) of evaluation of this end point: N/A | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Type, frequency, and severity of treatment-emergent adverse events (TEAEs); adverse events of special interest (AESIs); safety laboratory findings; vital signs; electrocardiography (ECG) findings; • ORR according to RECIST for immune-based therapeutics (iRECIST) (iORR) in patients with measurable disease • Best overall response according to RECIST 1.1 (BOR) and iRECIST (iBOR) in patients with measurable disease • Duration of response according to RECIST 1.1 (DoR), iRECIST (iDoR), and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified RECIST 1.1 (metastatic castration-resistant prostate cancer [mCRPC] only) • Clinical benefit rate according to RECIST 1.1 (CBR), iRECIST (iCBR), and PCWG3-modified RECIST 1.1 (mCRPC only) • Progression-free survival (PFS) according to RECIST 1.1, iRECIST (iPFS), and PCWG3-modified RECIST 1.1 (mCRPC only) • Time to response according to RECIST 1.1 (TtR) and iRECIST (iTtR) in patients with measurable disease • mCRPC only: o Circulating tumor cell (CTC) count conversion from >5 to <5 cells per 7.5 mL of blood o Confirmed prostate-specific antigen (PSA) decline of =50% o Time to confirmed PSA progression • Plasma concentrations of SOT101 over time; • Incidence, titer, and time course of anti-drug antibodies (ADAs) against SOT101;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Belgium, Czechia, Czech Republic, France, Georgia, Germany, Hungary, Italy, Poland, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial SOTIO
SOTIO Biotech a.s.
Outcome results
None listed