Overview

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

Status:
Not yet recruiting
Trial end date:
2025-07-11
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of the study is to estimate the antitumor efficacy of SOT101 in combination with pembrolizumab in selected tumors.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
SOTIO Biotech AG
Treatments:
Pembrolizumab
Criteria
Inclusion Criteria:

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

1. Non-small cell lung cancer (NSCLC).

2. Colorectal cancer.

3. Cutaneous squamous cell carcinoma (cSCC).

4. Advanced hepatocellular carcinoma.

5. mCRPC.

6. 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.

- Accessible tumor tissue available for fresh biopsy except for mCRPC with no accessible
tumor tissue

- 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:

1. Hematology:

1. Absolute neutrophil count ≥1500/μL.

2. Platelets ≥100 000/μL.

3. Hemoglobin ≥9.0 g/dL .

2. Renal function: Creatinine clearance as measured by glomerular filtration rate
≥30 mL/min using Cockcroft-Gault equation.

3. 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.

4. 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:

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).

2. Less than 4 weeks from major surgeries and not recovered adequately.

- Has received prior radiotherapy within 2 weeks.

- 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:

1. Cardiomyopathy, with left ventricular ejection fraction ≤ 50%.

2. Congestive heart failure of New York Heart Association grade ≥2.

3. History of clinically significant artery or coronary heart disease.

4. Prolongation of QTcF >450 msec .

5. 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.