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

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

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