A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations who have Previously Received Platinum-Based Systemic Chemotherapy

Cullinan Oncology Inc.0 sites305 target enrollmentJanuary 16, 2023

Conditionson-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations MedDRA version: 21.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: on-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
Sponsor: Cullinan Oncology Inc.
Enrollment: 305
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 16, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Cullinan Oncology Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (all patients). For module A only, histologically or cytologically confirmed solid tumor with the exception of esophageal, gastric, pancreatic, hepatobiliary, or small bowel carcinomas, or history of gastric resection.
•2\. Documented EGFR exon 20 insertion (ex20ins) mutation demonstrated by a validated test (per protocol) and performed in a Clinical Laboratory Improvement Amendments (CLIA)\-certified or equivalent laboratory (all patients other than Module A Food Effect PK Assessment Module).
•3\. Prior treatment in the recurrent/metastatic disease setting including:
•a. A platinum\-based chemotherapy regiment (or other chemotherapy regimen if platinum\-based chemotherapy is contra\-indicated)
•b. Any other approved standard therapy that is available to the patient, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient. In the case of a patient declining such therapy, documentation that the patient has been informed and declined should be documented in the medical record.
•c. No prior therapy is required for patients enrolled on Module A.
•d. Prior therapy with an agent approved by the local regulatory authorities for the treatment of EGFR ex20ins mutant NSCLC (Module C only).
•4\. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1\.1 (except for patients enrolled on Module A).
•5\. Age \= 18 years.
•6\. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\.

Exclusion Criteria

•R6, Phase 1 Expansion, Phase 2a, Module A and Module B Patients Only
•1\. Prior treatment with an EGFR ex20ins\-targeting drug (see protocol for examples). Note: enrolment of patients treated previously with EGFR ex20ins\-targeting drugs allowed selectively during accelerated titration dose escalation and Module C only.
•Module A Patients Only
•2\. Conditions that compromise esophageal or gastrointestinal (GI) function.
•3\. Recurrent diarrhea, nausea, or vomiting.
•4\. Unable to refrain from or anticipates use of any drug, including prescription and non\-prescription medications (see protocol for further details) for the periods defined in the protocol.
•5\. Any allergies to the composition of the high fat meal.
•6\. Patients who use tobacco products.
•All Patients
•7\. History of COVID\-19\-related pneumonitis requiring hospitalization.