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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05256381
• Other study ID #: SC104
• Secondary ID: KEYNOTE-D13AUREL
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 21, 2022
• Est. completion date: July 30, 2025

Study information

• Verified date: September 2023
• Source: Sotio Biotech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: July 30, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell
• Castration-resistant Prostate Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Cutaneous Squamous Cell Carcinoma
• Hepatocellular Carcinoma
• Non-Small Cell Lung Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Prostatic Neoplasms

Intervention

Drug:
• Nanrilkefusp Alfa
Subcutaneous (SC) injection.
• Pembrolizumab
Intravenous (IV) infusion via peripheral or central venous line.

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Anderlecht
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Grand Hospital de Charleroi	Charleroi
Belgium	Universitair Ziekenhuis Leuven - Campus Gasthuisberg	Leuven
Belgium	Centre Hospitalier Universitaire de Liège	Liège
Czechia	Masarykuv Onkologicky Ustav	Brno
Czechia	Nemocnice Horovice	Horovice
Czechia	Fakultní nemocnice Olomouc	Olomouc
France	Hôpital Ambroise-Paré	Boulogne-Billancourt
France	Merchant Logo Institute Bergonié	Bourdeaux
France	Centre de Lutte Contre le Cancer	Caen
France	Hospital del la Timone	Marseille
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	Centre Antoine Lacassagne	Nice
France	Hospital L'archet	Nice
France	Hôpital Foch	Suresnes
France	Institute Claudius Regaud	Toulouse
France	Gustave Roussy	Villejuif
Georgia	High Technology Hospital MedCenter Ltd - Batumi	Batumi
Georgia	Evex Hospitals- Kutaisi Referral	Kutaisi
Georgia	Consilium Medulla Multiprofile Clinic	Tbilisi
Georgia	Evex Hospitals - Caraps Medline	Tbilisi
Georgia	Evex Hospitals - Caucasus Medical Center	Tbilisi
Georgia	Jerarsi Clinic	Tbilisi
Georgia	LLC Todua Clinic	Tbilisi
Georgia	New Vision University Hospital	Tbilisi
Georgia	Tbilisi Institute of Medicine	Tbilisi
Hungary	Észak-Pesti Centrumkórház - Honvédkórház	Budapest
Hungary	Petz Aladár Egyetemi Oktató Kórház - Gyor	Gyor
Italy	Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia	Brescia
Italy	Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST	Meldola
Italy	Instituto Nazionale Tumori IRCCS Fondazione G. Pascale	Napoli
Italy	Ospedale Guglielmo da Saliceto	Piacenza
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Rome
Italy	Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte	Siena
Italy	Ospedale Civile di Sondrio	Sondrio
Italy	Azienda Ospedaliera Universitaria Integrata Verona	Verona
Poland	Uniwersytecki Szpital Kliniczny w Poznaniu	Poznan	Wielkopolskie
Poland	Pratia Poznan	Skorzewo
Poland	MTZ Clinical Research powered by Pratia	Warszawa
Spain	Hospital Teresa Herrera - Materno Infantil	A Coruña
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	Hospital Universitari Vall d'Hebrón	Barcelona
Spain	Institut Catala d'Oncologia	Barcelona
Spain	Clínica Universidad de Navarra - Madrid	Madrid
Spain	Clinica Universidad de Navarra - Pamplona	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Madrid
Spain	Hospital Clínico Universitario de Valencia	Valencia
United States	University of Pittsburg Medical Center (UPMC) Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Innovative Clinical Research Institute	Whittier	California

Sponsors (2)

Lead Sponsor	Collaborator
SOTIO Biotech AG	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  France,  Georgia,  Hungary,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)		Day 1 up to approximately 3 years
Secondary	Number of Participants with a Treatment-emergent Adverse Event (TEAE)		Day 1 up to approximately 3 years
Secondary	Number of Participants with an Adverse Event of Special Interest (AESI)		Day 1 up to approximately 3 years
Secondary	Immune ORR (iORR) According to RECIST for immune-based therapeutics (iRECIST)		Day 1 up to approximately 3 years
Secondary	Best Overall Response (BOR) According to RECIST 1.1		Day 1 up to approximately 3 years
Secondary	Immune BOR (iBOR) According to iRECIST		Day 1 up to approximately 3 years
Secondary	Duration of Response (DoR) According to RECIST 1.1		Day 1 up to approximately 3 years
Secondary	Immune DoR (iDoR) According to iRECIST		Day 1 up to approximately 3 years
Secondary	Clinical Benefit Rate (CBR) According to RECIST 1.1		Day 1 up to approximately 3 years
Secondary	Immune CBR (iCBR) According to iRECIST		Day 1 up to approximately 3 years
Secondary	Progression-free Survival (PFS) According to RECIST 1.1		Day 1 up to approximately 3 years
Secondary	Immune PFS (iPFS) According to iRECIST		Day 1 up to approximately 3 years
Secondary	Time to Response (TtR) According to RECIST 1.1		Day 1 up to approximately 3 years
Secondary	Immune TtR (iTtR) According to iRECIST		Day 1 up to approximately 3 years
Secondary	Metastatic Castration-resistant Prostate Cancer (mCRPC) only: DoR as Assessed According to Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified RECIST 1.1		Day 1 up to approximately 3 years
Secondary	mCRPC only: CBR as Assessed According to PCWG3-modified RECIST 1.1		Day 1 up to approximately 3 years
Secondary	mCRPC only: PFS as Assessed According to PCWG3-modified RECIST 1.1		Day 1 up to approximately 3 years
Secondary	mCRPC only: Circulating Tumor Cell (CTC) Count Conversion as Assessed According to PCWG3-modified RECIST 1.1		Day 1 up to approximately 2 years
Secondary	mCRPC only: Confirmed Prostate-specific Antigen (PSA) Decline of =50% as Assessed According to PCWG3-modified RECIST 1.1		Day 1 up to approximately 2 years
Secondary	mCRPC only: Time to Confirmed PSA Progression as Assessed According to PCWG3-modified RECIST 1.1		Day 1 up to approximately 2 years
Secondary	Nanrilkefusp Alfa Concentration Profile at Various Timepoints		Cycle 1 Day 1 to Cycle 3 Day 1 (up to approximately 9 weeks, where each cycle is 3 weeks)
Secondary	Number of Participants with Anti-drug Antibodies (ADAs)		Day 1 up to approximately 2 years