A Phase 1/2 interventional study of SOT106 in Osteosarcoma Metastatic, Soft Tissue Sarcoma (STS) and Osteosarcoma, Advanced, sponsored by SOTIO Biotech a.s.. Not yet recruiting at 1 site in Moldova. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by SOTIO Biotech a.s. · Phase 1/2, Interventional, and Treatment
SOT106 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called LRRC15, while causing less harm to healthy cells. The study consists of two parts, Part A and Part B. The goal of Part A is to collect information about SOT106, understand its effects, and see whether it is safe and well tolerated at different dose levels. Part B of the study collects information on which of the two selected safe dose levels chosen in Part A gives the best balance between benefit and risk.
The trial will consist of the following parts:
488 studies on the registry are indexed under Osteosarcoma; 124 are open to participants now.
This study's planned enrollment of 70 is above the median of 40 across 354 interventional studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →SOTIO Biotech a.s. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Compared within Osteosarcoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sarcoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
≥18 years of age and body weight of ≥30 kg on the day of signing the prescreening ICF
Availability of adequate tumor tissue from an archival (FFPE block or unstained slides) or willingness to undergo a fresh tumor biopsy. A minimum of ≥1% (1+) of cells must exhibit LRRC15 expression with an intensity of at least 1+ by IHC.
Note: Tumor samples will be sent to a central laboratory for LRRC15 expression analysis.
Renal function:
≤1.5× (ULN), and AST ≤2.5×ULN; in case of liver involvement: AST and ALT ≤5×ULN.
Previous cancer therapies:
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies:
Exclusion Criteria:
Known symptomatic positive, symptomatic active , or symptomatic active
Note:
Participants with HIV will be eligible if:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with LRRC15-positive advanced unresectable or metastatic osteosarcoma and soft tissue sarcoma treated with SOT106 given once every 21 days via the IV route over 45 (±15) minutes.
Biological: SOT106
Patients with LRRC15-positive advanced unresectable or metastatic osteosarcoma and soft tissue sarcoma treated with SOT106 given once every 21 days via the IV route over 45 (±15) minutes.
Biological: SOT106
Patients with LRRC15-positive advanced unresectable or metastatic osteosarcoma and soft tissue sarcoma treated with SOT106 given once every 21 days via the IV route over 45 (±15) minutes.
Biological: SOT106
Patients with LRRC15-positive advanced unresectable or metastatic osteosarcoma and soft tissue sarcoma treated with SOT106 given once every 21 days via the IV route over 45 (±15) minutes.
Biological: SOT106
Patients with LRRC15-positive advanced unresectable or metastatic osteosarcoma and soft tissue sarcoma treated with SOT106 given once every 21 days via the IV route over 45 (±15) minutes.
Biological: SOT106
Patients with LRRC15-positive advanced unresectable or metastatic osteosarcoma and soft tissue sarcoma treated with SOT106 given once every 21 days via the IV route over 45 (±15) minutes.
Biological: SOT106
SOT106 is a LRRC15-directed monoclonal antibody conjugated to a linker-payload, Monomethyl auristatin E
Part A: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT106
MTD will be selected as guided by the time to-event Bayesian optimal interval (TITEBOIN) design. The RP2D will be selected based on integrated evaluation of the totality of clinical and preclinical data, for all dose levels tested.
Time frame: At the end of Cycle 1 (one cycle is 21 days)
Part B: Optimal dose of SOT106 for subsequent clinical trials
Assessment of the safety and tolerability of two recommended doses under evaluation for dose optimization (RDOs) of SOT106 by evaluation of the occurrence of SOT106 related TEAEs, serious TEAEs, TEAEs leading to premature discontinuation of SOT106, deaths, and clinical laboratory test abnormalities of grade 3 or higher according to NCI CTCAE Version 6.0
Time frame: Cycle 1 Day 1 up to 30 days after the last dose (each cycle is 21 days)
Part B: Objective Response Rate (ORR) of SOT106
Percentage of participants who achieve a Best Overall Response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: From Day 1 of Cycle 1 (one cycle is 21 days) until disease progression, initiation of new anticancer therapy, withdrawal of consent, or study discontinuation, whichever comes first, to be assessed up to approximately 10 months
Part B: Duration of Response (DoR) of SOT106
The time from the first documentation of objective response (CR or PR) to the first documented date of progressive disease (PD) according to RECIST v1.1.
Time frame: From the date of first documented objective response until disease progression, initiation of new anticancer therapy, withdrawal of consent, or study discontinuation, whichever comes first, assessed up to approximately 10 months.
Part A: Safety and Tolerability of SOT106
The occurrence of dose-limiting toxicities (DLTs), SOT106-related treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs leading to premature discontinuation of SOT106, deaths, and clinical laboratory test abnormalities of grade 3 or higher according to National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) Version 6.0
Time frame: From Cycle 1 Day 1 (one cycle is 21 days) assessed for approximately 17 months
Part A: Characterization of maximum concentration (Cmax)
Cmax in plasma of total antibody, conjugated antibody and free MMAE
Time frame: From Cycle 1 Day 1 up to approximately 17 months (each cycle is 21 days)
Part A: Characterization of time to maximum concentration (Tmax)
Time to maximum concentration of total antibody, conjugated antibody and free MMAE.
Time frame: From Cycle 1 Day 1 up to approximately 17 months (each cycle is 21 days)
Part A: Characterization of area under the curve
Area under the concentration versus time curve calculated for total antibody, conjugated antibody and free MMAE.
Time frame: From Cycle 1 Day 1 up to approximately 17 months (each cycle is 21 days)
Part A: Preliminary anticancer activity of SOT106
Tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by LRRC15 expression
Time frame: From Day 1 of Cycle 1 (one cycle is 21 days) until disease progression, initiation of new anticancer therapy, withdrawal of consent, or study discontinuation, whichever comes first, to be assessed up to approximately 17 months
Part A: Immunogenicity of SOT106 as Evaluated by Anti-Drug Antibody (ADA) Incidence
Proportion of participants who test positive for ADAs to SOT106.
Time frame: From Cycle 1 Day 1 up to approximately 17 months (each cycle is 21 days)
Part B: Progression-Free Survival (PFS) of SOT106
Progression-free survival is defined as the time from Cycle 1 Day 1 to the first documented date of progressive disease (PD) according to RECIST v1.1, or death from any cause, whichever occurs first
Time frame: From Cycle 1 Day 1 (one cycle is 21 days) until first documented disease progression or death from any cause, assessed up to approximately 10 months
Part B: Characterization of Cmax
Evaluation of the maximum plasma concentration (Cmax) for total antibody, conjugated antibody, and free MMAE payload.
Time frame: From Cycle 1 Day 1 up to approximately 10 months (each cycle is 21 days)
Part B: Characterization of Tmax
Evaluation of the time to maximum plasma concentration (Tmax) for total antibody, conjugated antibody, and free payload.
Time frame: From Cycle 1 Day 1 up to approximately 10 months (each cycle is 21 days)
Part B: Characterization of area under the curve
To characterize the total drug exposure over time (AUC) for total antibody, conjugated antibody, and free payload.
Time frame: From Cycle 1 Day 1 up to approximately 10 months (each cycle is 21 days)
Part B: Immunogenicity of SOT106 as Evaluated by Anti-Drug Antibody (ADA) Incidence
Proportion of participants who test positive for ADAs to SOT106. The potential impact of ADA status on the pharmacokinetic (PK) profiles (Cmax, AUC, Tmax) of SOT106 will be evaluated by comparing PK data between ADA-positive and ADA-negative participants
Time frame: From Cycle 1 Day 1 up to approximately 10 months (each cycle is 21 days)
Part A: Baseline LRRC15 expression in tumor tissue
Baseline LRRC15 expression in tumor tissue, as determined by immunohistochemistry (IHC) and quantified as the percentage of LRRC15-positive tumor cells
Time frame: From Cycle 1 Day 1 up to approximately 17 months (each cycle is 21 days)
Part B: Baseline LRRC15 expression in tumor tissue
Baseline LRRC15 expression in tumor tissue, as determined by immunohistochemistry (IHC) and quantified as the percentage of LRRC15-positive tumor cells
Time frame: From Cycle 1 Day 1 up to approximately 10 months (each cycle is 21 days)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jan 2029, 27 months later.
Of 33 phase 1/2 interventional studies under Osteosarcoma, half reached primary completion within 77 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 92. This study's planned 27 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
SOTIO Biotech a.s.