Loading clinical trials...

A Phase I Study of CFT8919 in Patients With Advanced NSCLC | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

A Phase I Study of CFT8919 in Patients With Advanced NSCLC

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of CFT8919 Capsules in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).

NCT06641609•Betta Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR mutations. The main questions it aims to answer are: * What is the maximum tolerated dose (MTD) of CFT8919? * Does CFT8919 demonstrate antitumor activity in these patients? Participants will: * Take CFT8919 capsules at different doses. * Undergo regular assessments for safety, pharmacokinetics, and tumor response. Researchers will compare different dose levels to determine the best balance between safety and efficacy.

Detailed Description

This is a Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who carry EGFR mutations. The study includes three parts: dose-escalation, dose-expansion, and cohort-expansion. The primary objectives are to determine the maximum tolerated dose (MTD) in the dose-escalation phase and to assess the antitumor efficacy in the cohort-expansion phase. Secondary objectives include assessing pharmacokinetic parameters, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Exploratory objectives will evaluate biomarkers and the relationship between drug exposure and treatment outcomes.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Dose-Escalation and Dose-Expansion Phases: Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR-L858R mutation, who have failed standard treatment (disease progression or intolerance), lack standard treatment options, or are deemed unsuitable for standard treatment by the investigator, or have refused standard treatment.
•2. Cohort-Expansion Phase: In addition to the above criteria, the following must also be met:
•* Cohort A: Patients with locally advanced or metastatic NSCLC harboring the EGFR-L858R mutation who have experienced disease progression after third-generation EGFR-TKI treatment and carry secondary EGFR mutations (such as C797S, L718Q, G724S, S768I, etc.).
•* Cohort B: Patients with locally advanced or metastatic NSCLC harboring the EGFR-L858R mutation who have failed standard treatment or are unsuitable for or have refused standard treatment (patients with secondary EGFR mutations are prioritized for Cohort A).
•3. • Dose-Escalation Phase requires evaluable lesions, while Dose-Expansion and Cohort-Expansion Phases require measurable lesions as defined by RECIST V1.1.
•4. • Age ≥18 years, no gender restrictions.
•5. • Expected survival ≥12 weeks.
•6. • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
•7. • Adequate organ function, meeting the following criteria:
•* Hematologic: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (1500/mm³), platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL (90 g/L) without transfusion or hematopoietic growth factors within 14 days prior to screening.
+8 more criteria

Exclusion Criteria

•1. Prior or ongoing treatment with EGFR-L858R-targeted PROTAC therapies.
•2. Less than 5 half-lives or 4 weeks (whichever is shorter) since the last anti-tumor treatment before the first dose of study drug; less than 6 weeks since the last treatment with nitrosoureas or mitomycin C; less than 1 week since the last anti-tumor herbal treatment.
•3. Patients who underwent major surgery (as defined by the investigator) or experienced significant trauma within 4 weeks before the first dose of study drug; patients who received radiation therapy within 4 weeks prior to the first dose, except for palliative radiation (e.g., for bone metastases to control pain) that is unlikely to affect bone marrow function, which may allow inclusion 2 weeks post-radiation.
•4. Patients with unstable central nervous system (CNS) metastases (those who have received treatment for brain metastases, have stable brain lesions, and have discontinued corticosteroids, anticonvulsants, or mannitol treatment for ≥2 weeks before the first dose may be considered for inclusion); patients with leptomeningeal metastases or spinal cord compression.
•5. History of other primary malignancies within the past 3 years, except for malignancies that have been treated curatively with no known active disease and a low risk of recurrence, or adequately treated non-melanoma skin cancers, cervical carcinoma in situ, or papillary thyroid carcinoma.
•6. Clinically significant cardiovascular diseases, including but not limited to:
•* a) Unstable angina, acute myocardial infarction, or New York Heart Association (NYHA) class II-IV heart failure;
•* b) Ventricular arrhythmias or conduction disorders requiring clinical intervention (e.g., complete left bundle branch block, third-degree atrioventricular \[AV\] block, or second-degree AV block);
•* c) Uncontrolled atrial fibrillation or atrial flutter;
•* d) Prolonged QTcF interval (resting mean QTcF \>450 msec for men or \>470 msec for women);
+14 more criteria

Locations (1)

浙江省杭州市拱墅区半山东路1号的英文翻译为： No. 1 Banshan East Road, Gongshu District, Hangzhou, Zhejiang Province, China

Hangzhou, Zhejiang, China

Key Dates

Start Date

December 13, 2024

Primary Completion Date

December 9, 2025

Completion Date

April 3, 2026

Last Updated

October 15, 2024

Enrollment

166

ESTIMATED participants

Conditions

Non-Small Cell Lung Cancer With EGFR Mutation

Interventions

Dose-Escalation (Phase Ia) CFT8919 capsule

DRUG

Dose-Expansion (Phase Ib) CFT8919 capsule

DRUG

Cohort-Expansion (Phase Ic) CFT8919 capsule

DRUG

Contacts

yun fan, PHD

CONTACT

86-0571-88122092 fanyun@zjcc.org.cn

A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib

NCT06668103

Non-Small Cell Lung Cancer With EGFR Mutation

View study

COMPLETEDPHASE2

Keynatinib in Treated Patients With NSCLC and Brain Metastases

NCT04824079

Non-Small Cell Lung Cancer With EGFR MutationBrain Metastases

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions