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History of Changes for Study: NCT05256381
A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors
Latest version (submitted March 6, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 24, 2022 None (earliest Version on record)
2 April 8, 2022 Study Status and Sponsor/Collaborators
3 June 17, 2022 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 June 27, 2022 Study Status
5 July 25, 2022 Study Status and Contacts/Locations
6 August 25, 2022 Study Status and Contacts/Locations
7 September 27, 2022 Study Status and Contacts/Locations
8 January 5, 2023 Study Status and Contacts/Locations
9 March 6, 2024 Recruitment Status, Contacts/Locations, Arms and Interventions, Study Status, Eligibility, Outcome Measures, Conditions, Study Description and Study Identification
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Study NCT05256381
Submitted Date:  February 24, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: SC104
Brief Title: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors
Official Title: A Phase 2, Open-label, Single-arm, Multicenter Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced/Refractory Solid Tumors
Secondary IDs: KEYNOTE-D13 [Merck Sharp & Dohme]
AURELIO-04 [SOTIO Biotech AG]
2021-005774-25 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2022
Overall Status: Not yet recruiting
Study Start: March 22, 2022
Primary Completion: September 22, 2023 [Anticipated]
Study Completion: July 11, 2025 [Anticipated]
First Submitted: February 8, 2022
First Submitted that
Met QC Criteria:
February 24, 2022
First Posted: February 25, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
February 24, 2022
Last Update Posted: February 25, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: SOTIO Biotech AG
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The primary objective of the study is to estimate the antitumor efficacy of SOT101 in combination with pembrolizumab in selected tumors.
Detailed Description:
Open or close this module Conditions
Conditions: Non-Small Cell Lung Cancer
Colorectal Cancer
Cutaneous Squamous Cell Carcinoma
Hepatocellular Carcinoma
Castration-resistant Prostate Cancer
Ovarian Cancer
Keywords: SOT101
SO-C101
Pembrolizumab
Non-Small Cell Lung Cancer
Colorectal Cancer
Cutaneous Squamous Cell Carcinoma
Advanced Hepatocellular Carcinoma
Metastatic Castration-resistant Prostate Cancer
Ovarian Cancer
KEYNOTE-D13
AURELIO-04
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 320 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: SOT101 and Pembrolizumab
Participants will be treated with 12 μg/kg of SOT101 on Day 1, Day 2, Day 8, and Day 9 of each 3-week cycle in combination with 200 mg pembrolizumab on Day 1 of each 3-week cycle.
Drug: SOT101
Subcutaneous (SC) injection.
Drug: Pembrolizumab
Intravenous (IV) infusion via peripheral or central venous line.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
[ Time Frame: Day 1 up to approximately 3 years ]

Secondary Outcome Measures:
1. Number of Participants with a Treatment-emergent Adverse Event (TEAE)
[ Time Frame: Day 1 up to approximately 3 years ]

2. Number of Participants with an Adverse Event of Special Interest (AESI)
[ Time Frame: Day 1 up to approximately 3 years ]

3. Immune ORR (iORR) According to RECIST for immune-based therapeutics (iRECIST)
[ Time Frame: Day 1 up to approximately 3 years ]

4. Best Overall Response (BOR) According to RECIST 1.1
[ Time Frame: Day 1 up to approximately 3 years ]

5. Immune BOR (iBOR) According to iRECIST
[ Time Frame: Day 1 up to approximately 3 years ]

6. Duration of Response (DoR) According to RECIST 1.1
[ Time Frame: Day 1 up to approximately 3 years ]

7. Immune DoR (iDoR) According to iRECIST
[ Time Frame: Day 1 up to approximately 3 years ]

8. Clinical Benefit Rate (CBR) According to RECIST 1.1
[ Time Frame: Day 1 up to approximately 3 years ]

9. Immune CBR (iCBR) According to iRECIST
[ Time Frame: Day 1 up to approximately 3 years ]

10. Progression-free Survival (PFS) According to RECIST 1.1
[ Time Frame: Day 1 up to approximately 3 years ]

11. Immune PFS (iPFS) According to iRECIST
[ Time Frame: Day 1 up to approximately 3 years ]

12. Time to Response (TtR) According to RECIST 1.1
[ Time Frame: Day 1 up to approximately 3 years ]

13. Immune TtR (iTtR) According to iRECIST
[ Time Frame: Day 1 up to approximately 3 years ]

14. Metastatic Castration-resistant Prostate Cancer (mCRPC) only: DoR as Assessed According to Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified RECIST 1.1
[ Time Frame: Day 1 up to approximately 3 years ]

15. mCRPC only: CBR as Assessed According to PCWG3-modified RECIST 1.1
[ Time Frame: Day 1 up to approximately 3 years ]

16. mCRPC only: PFS as Assessed According to PCWG3-modified RECIST 1.1
[ Time Frame: Day 1 up to approximately 3 years ]

17. mCRPC only: Circulating Tumor Cell (CTC) Count Conversion as Assessed According to PCWG3-modified RECIST 1.1
[ Time Frame: Day 1 up to approximately 2 years ]

18. mCRPC only: Confirmed Prostate-specific Antigen (PSA) Decline of ≥50% as Assessed According to PCWG3-modified RECIST 1.1
[ Time Frame: Day 1 up to approximately 2 years ]

19. mCRPC only: Time to Confirmed PSA Progression as Assessed According to PCWG3-modified RECIST 1.1
[ Time Frame: Day 1 up to approximately 2 years ]

20. SOT101 Plasma Concentration Profile at Various Timepoints
[ Time Frame: Cycle 1 Day 1 to Cycle 3 Day 1 (up to approximately 9 weeks, where each cycle is 3 weeks) ]

21. Number of Participants with Anti-drug Antibodies (ADAs)
[ Time Frame: Day 1 up to approximately 2 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Richard Kapsa
Telephone: (+420) 2241 74448
Email: kapsa@sotio.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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