Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Antineoplastic Agents, Immunological

Participants will be first treated with 9 µg/kg of nanrilkefusp alfa and then proceed to be treated with either 12 µg/kg or 6 µg/kg of nanrilkefusp alfa in combination with cetuximab (depending on the safety evaluation of the first safety cohort). Nanrilkefusp alfa treatment will be administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment will be administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion will start within 30 minutes after nanrilkefusp alfa administration.

Nanrilkefusp alfa

Intravenous (IV) infusion via peripheral or central venous line

The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa (SOT101) in combination with cetuximab in RAS wild-type colorectal cancer.

Two safety cohorts will be implemented in a 3+3 dose escalation design. The main cohort will start only after data from safety cohorts are assessed by an internal safety committee.

A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer

A Phase 2, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of SOT101 in Combination With Cetuximab in Patients With RAS Wild-type Colorectal Cancer

A TEAE is defined as an AE that started or worsened at or after the start of study treatment.

The following laboratory parameters will be assessed:

Coagulation: prothrombin time, activated partial thromboplastin time, international normalized ratio, D-dimer, and fibrinogen

Hematology: hemoglobin, glycated hemoglobin at screening, hematocrit, red blood cell count, reticulocytes, white blood cell count (with full differentiation), absolute lymphocyte count, and platelet count

Clinical chemistry: Na, K, Cl, phosphate, Mg, Ca, albumin, total protein, ALT, AST, bilirubin (direct, total), alkaline phosphatase, lactate dehydrogenase, creatinine clearance calculated by the Cockcroft-Gault formula, creatinine, glucose (preferably fasting), urea or blood urea nitrogen, cholesterol, triglyceride, C-reactive protein, uric acid, amylase, and lipase

Urinalysis: pH, glucose, protein, bilirubin, urobilinogen. Microscopic examination (mandated only if clinically indicated): red blood cell count, white blood cell count, epithelial cells, bacteria

The following vital signs parameters will be assessed:

Blood pressure (systolic and diastolic, after ≥5 minutes of rest), body temperature, and heart rate

AEs as per NCI CTCAE v5.0 considered DLTs:

* All G5 events not clearly related to disease progression or any other causes will be considered DLTs
* Any G3 or higher non-hematologic toxicity regardless of duration will be considered a DLT, with the following exceptions that are not considered DLTs:

  * G3 nausea, vomiting, or diarrhea that can be controlled within 72 hours
  * G3 fatigue that lasts less than 5 days
  * G3 or higher correctable electrolyte abnormalities that last less than 72 hours and are not associated with clinical complications
  * G3 or higher serum amylase or lipase not associated with clinical manifestations of pancreatitis
  * G3 AST or ALT increase or G3 blood bilirubin increase that lasts 5 days or less
* Hy's law cases will be considered DLTs.
* Hematologic DLTs will include the following:

  * G4 decreased neutrophil count or decreased platelet count lasting more than 7 days
  * Febrile neutropenia
  * G3 or higher decreased platelet count with bleeding

Assessment of concentration of nanrilkefusp alfa at various timepoints

SOTIO Biotech AG

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Prostatic Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms, Squamous Cell

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Pembrolizumab

Immune Checkpoint Inhibitors

Participants will be treated with 12 μg/kg of nanrilkefusp alfa 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.

Nanrilkefusp Alfa

Intravenous (IV) infusion via peripheral or central venous line.

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

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

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

Merck Sharp & Dohme LLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer	NCT05619172	Colorectal Canc...	Nanrilkefusp al... Cetuximab	18 Years -	Sotio Biotech Inc.
A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer	NCT05619172	Colorectal Canc...	Nanrilkefusp al... Cetuximab	18 Years -	Sotio Biotech Inc.
A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors	NCT05256381	Non-Small Cell ... Colorectal Canc... Cutaneous Squam... Hepatocellular ... Castration-resi... Ovarian Cancer	Nanrilkefusp Al... Pembrolizumab	18 Years -	Sotio Biotech Inc.

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