Clinical trial NCT05256381: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Nanrilkefusp Alfa
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-02-25
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa in combination with pembrolizumab in selected tumors.


Eligibility 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 (not applicable in France).
  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.
* Availability of tumor tissue from a fresh biopsy at screening unless the biopsy cannot be obtained due to safety reasons or non-accessibility of the tumor site. If it is not possible to obtain a fresh biopsy, every effort should be taken to retrieve an archival biopsy. Archived, fixed tumor tissue may only be collected if taken preferentially after completion of the most recent systemic tumor therapy and within 12 months prior to the first dose of study treatment.
* 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 of the start of study interventions or have had a history of radiation pneumonitis.
* 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.

Primary outcomes:
measure: Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
timeFrame: Day 1 up to approximately 3 years
Secondary outcomes:
measure: Number of Participants with a Treatment-emergent Adverse Event (TEAE)
timeFrame: Day 1 up to approximately 3 years
measure: Number of Participants with an Adverse Event of Special Interest (AESI)
timeFrame: Day 1 up to approximately 3 years
measure: Immune ORR (iORR) According to RECIST for immune-based therapeutics (iRECIST)
timeFrame: Day 1 up to approximately 3 years
measure: Best Overall Response (BOR) According to RECIST 1.1
timeFrame: Day 1 up to approximately 3 years
measure: Immune BOR (iBOR) According to iRECIST
timeFrame: Day 1 up to approximately 3 years
measure: Duration of Response (DoR) According to RECIST 1.1
timeFrame: Day 1 up to approximately 3 years
measure: Immune DoR (iDoR) According to iRECIST
timeFrame: Day 1 up to approximately 3 years
measure: Clinical Benefit Rate (CBR) According to RECIST 1.1
timeFrame: Day 1 up to approximately 3 years
measure: Immune CBR (iCBR) According to iRECIST
timeFrame: Day 1 up to approximately 3 years
measure: Progression-free Survival (PFS) According to RECIST 1.1
timeFrame: Day 1 up to approximately 3 years
measure: Immune PFS (iPFS) According to iRECIST
timeFrame: Day 1 up to approximately 3 years
measure: Time to Response (TtR) According to RECIST 1.1
timeFrame: Day 1 up to approximately 3 years
measure: Immune TtR (iTtR) According to iRECIST
timeFrame: Day 1 up to approximately 3 years
measure: Metastatic Castration-resistant Prostate Cancer (mCRPC) only: DoR as Assessed According to Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified RECIST 1.1
timeFrame: Day 1 up to approximately 3 years
measure: mCRPC only: CBR as Assessed According to PCWG3-modified RECIST 1.1
timeFrame: Day 1 up to approximately 3 years
measure: mCRPC only: PFS as Assessed According to PCWG3-modified RECIST 1.1
timeFrame: Day 1 up to approximately 3 years
measure: mCRPC only: Circulating Tumor Cell (CTC) Count Conversion as Assessed According to PCWG3-modified RECIST 1.1
timeFrame: Day 1 up to approximately 2 years
measure: mCRPC only: Confirmed Prostate-specific Antigen (PSA) Decline of ≥50% as Assessed According to PCWG3-modified RECIST 1.1
timeFrame: Day 1 up to approximately 2 years
measure: mCRPC only: Time to Confirmed PSA Progression as Assessed According to PCWG3-modified RECIST 1.1
timeFrame: Day 1 up to approximately 2 years
measure: Nanrilkefusp Alfa Concentration Profile at Various Timepoints
timeFrame: Cycle 1 Day 1 to Cycle 3 Day 1 (up to approximately 9 weeks, where each cycle is 3 weeks)
measure: Number of Participants with Anti-drug Antibodies (ADAs)
timeFrame: Day 1 up to approximately 2 years
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Pittsburgh
country: United States
facility: University of Pittsburg Medical Center (UPMC) Hillman Cancer Center
state: Pennsylvania
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Charleroi
country: Belgium
facility: Grand Hospital de Charleroi
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Brno
country: Czechia
facility: Masarykuv Onkologicky Ustav
city: Hořovice
country: Czechia
facility: Nemocnice Hořovice
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise-Paré
city: Bourdeaux
country: France
facility: Merchant Logo Institute Bergonié
city: Caen
country: France
facility: Centre de Lutte Contre le Cancer
city: Caen
country: France
facility: Centre Francois Baclesser
city: Marseille
country: France
facility: Hospital del la Timone
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nice
country: France
facility: Hospital L'archet
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse Oncopole
city: Toulouse
country: France
facility: Institute Claudius Regaud
city: Villejuif
country: France
facility: Gustave Roussy
city: Batumi
country: Georgia
facility: High Technology Hospital MedCenter Ltd - Batumi
city: Kutaisi
country: Georgia
facility: Evex Hospitals- Kutaisi Referral
city: Tbilisi
country: Georgia
facility: LLC Todua Clinic
city: Tbilisi
country: Georgia
facility: Evex Hospitals - Caraps Medline
city: Tbilisi
country: Georgia
facility: New Vision University Hospital
city: Tbilisi
country: Georgia
facility: Tbilisi Institute of Medicine
city: Tbilisi
country: Georgia
facility: Jerarsi Clinic
city: Tbilisi
country: Georgia
facility: Consilium Medulla Multiprofile Clinic
city: Tbilisi
country: Georgia
facility: Evex Hospitals - Caucasus Medical Center
city: Budapest
country: Hungary
facility: Észak-Pesti Centrumkórház - Honvédkórház
city: Győr
country: Hungary
facility: Petz Aladár Egyetemi Oktató Kórház - Győr
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
city: Napoli
country: Italy
facility: Instituto Nazionale Tumori IRCCS Fondazione G. Pascale
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte
city: Sondrio
country: Italy
facility: Ospedale Civile di Sondrio
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Poznań
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
state: Wielkopolskie
city: Skorzewo
country: Poland
facility: Pratia Poznań
city: Warszawa
country: Poland
facility: MTZ Clinical Research powered by Pratia
city: A Coruña
country: Spain
facility: Hospital Teresa Herrera - Materno Infantil
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebrón
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologia
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra - Pamplona
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra - Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
References: