A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer

NCT06163391 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: SC201VICTORIA-012023-504330-21-00
• Study Type: interventional
• Target: 40
• Locations: 5 countries
• Sites: 7

Brief Summary

This is a Phase 1, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SOT201 as monotherapy for participants aged 18 years or above with advanced unresectable or metastatic solid tumors During dose escalation, the recommended dose(s) of SOT201 given every 3 weeks (Q3W) will be determined

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor

Keywords

Checkpoint inhibition plus RLI-15; SOT201; SC201; VICTORIA-01; RLI-15/CPI fusion protein; Immunocytokine

Outcome Measures

Primary Outcomes (2)

• Number and percentages of participants with treatment-emergent adverse events (TEAEs)

  A TEAE is defined as an AE that started or worsened at or after the start of trial treatment Presence of TEAEs, SAEs, and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

  from patient signing the ICF up to 90 (+7) days after the last dose of SOT201, assessed approximately up to 3 years

• Number of participants with dose-limiting toxicities (DLTs)

  DLTs will be defined using NCI CTCAE version 5.0

  21 days of Cycle 1 plus 7 days of cycle 2 per cycle

Secondary Outcomes (9)

• Characterization of area under the curve (AUClast, AUCinf, AUCtau) of SOT201

  From Day 1 Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17.) until cycle 20

• Characterization of maximum concentration (Cmax) of SOT201

  Time Frame: From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17.) until cycle 20]

• Characterization of time to maximum concentration (Tmax) of SOT201

  From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17..) until cycle 20

• Characterization of pre-dose concentration (Ctrough) of SOT201

  From Day 1 of Cycle 1 to Cycle 3, from cycle 4 every other cycle (4, 6, 8), and from cycle 8 at quarterly frequency (11, 14, 17..) until cycle 20

• Objective response rate (ORR)

  From Day 1 of Cycle 1 until disease progression or start new anticancer therapy, whichever comes first, assess to up to approximately 3 years

Study Arms (1)

SOT201

EXPERIMENTAL

SOT201 will be administered intravenously once every 21 days

Drug: SOT201

Interventions

SOT201 DRUG

intravenous infusion

SOT201

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type of patients
• Patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have disease progression after treatment with available therapies for their disease that are known to confer clinical benefit
• 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
• Accessible tumor tissue available for fresh biopsy or being considered for tumor biopsy according to the treating institution's guidelines and willing to undergo a new biopsy if not clinically contraindicated Note: Newly obtained tumor tissue (to be taken at baseline) is preferred to an archival sample. All tumor biopsies will be collected from the same target lesion, if possible. Archived, fixed tumor tissue may only be collected (taken ideally after completion of the most recent systemic tumor therapy and within 6 months prior to the first dose of trial treatment) if fresh biopsy at screening cannot be retrieved from patients due to safety concerns.
• Performance status: Eastern Cooperative Oncology Group (ECOG) performance score 0-1
• Must have recovered from all adverse events (AEs) due to previous therapies to grade ≤1 toxicity (excluding alopecia) or have stable grade 2 neuropathy as per investigators judgement Note: grade \>1 immune- related AEs to any prior treatments may be accepted if considered clinically nonsignificant and/or clinically stable on supportive therapy.
• Organ function: Have adequate organ function during screening and prior to first SOT201 dose.

You may not qualify if:

• Prior/concomitant therapy
• Known clinically relevant intolerability or severe hypersensitivity to prior anti PD-1 or anti-PD-L1 agent therapy, pembrolizumab and/or any of its excipients, or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, CD134 \[OX40\], CD137) that caused permanent discontinuation of the agent, or that were grade 4 in severity or have not resolved to grade ≤1.
• Prior exposure to drugs that are agonists or antagonists of IL-2, IL-4, IL-7, IL-8, IL-9, IL-12, IL-15, IL-18, IL-21 or IL-27 prior to ICF signature.
• Prior systemic anti-cancer therapies, including investigational agents, prior to day 1 cycle 1 signature if not otherwise indicated:
• Less than 3 weeks for all systemic chemotherapy
• Less than 3 weeks or 5 half-lives (whichever shorter) for any biologic agents
• Less than 4 weeks for ICIs (targeting CTLA-4, or PD-L1, including e.g., ipilimumab, atezolizumab, avelumab, durvalumab, cemiplimab) prior to cycle 1 day 1
• Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery before starting SOT201
• Has received radiation therapy ≤14 days before day 1 of cycle 1 or has not recovered to grade ≤1 from treatment-related side effects. A 1-week radiation-free period is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system disease.
• Use of prohibited medication prior or during the course of the trial as specified in the protocol
• Predicted life expectancy ≤3 months
• Clinically significant cardiac abnormalities
• 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)
• Diagnosis of other forms 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 before the first dose of SOT201
• 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 (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.

Sponsors & Collaborators

• SOTIO Biotech AG: lead

Study Sites (7)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Universitair Ziekenhuis Antwerpen (UZA)

Edegem, Antwerp, 2650, Belgium

RECRUITING

Institut Jules Bordet

Anderlecht, Brussels Capital, 1070, Belgium

RECRUITING

Masarykův Onkologický Ústav

Brno, Czechia

RECRUITING

Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika

Olomouc, 779 00, Czechia

WITHDRAWN

Institut Gustave Roussy

Paris, 94805, France

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)

Barcelona, 08035, Spain

RECRUITING

Related Publications (1)

• Matuskova H, Marasek P, Mazhara V, Simonova E, Kosinova L, Danek P, Danova K, Sajnerova K, Malatova I, Hrabankova K, Greco D, Martinec O, Fabisik M, Podzimkova N, Hladikova K, Behalova K, Antosova Z, Sirova M, Mikyskova R, Reinis M, Kovar M, Bechard D, Moebius U, Palova Jelinkova L, Spisek R, Steegmaier M, Adkins I. Novel PD-1-targeted, activity-optimized IL-15 mutein SOT201 acting in cis provides antitumor activity superior to PD1-IL2v. J Immunother Cancer. 2025 Apr 17;13(4):e010736. doi: 10.1136/jitc-2024-010736.

  PMID: 40250867 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aung Naing, MD, FCAP

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Kapsa

CONTACT

(+420) 2241 74448; kapsa@sotio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 6 cohorts, multiple-dose escalation, Bayesian optimal interval design (BOIN) trial

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); US (1); ES (1); CZ (2); FR (1)