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A Phase I Study of CFT8919 in Patients With Advanced NSCLC

NCT06641609 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

  • Non-Small Cell Lung Cancer With EGFR Mutation

Interventions

DRUG

Dose-Escalation (Phase Ia) CFT8919 capsule

Phase 1a，enrolled, eligible patients receive CFT8919 150-900mg twice daily.

DRUG

Dose-Expansion (Phase Ib) CFT8919 capsule

Phase 1b，enrolled, eligible patients receive CFT8919 RP2D twice daily.

DRUG

Cohort-Expansion (Phase Ic) CFT8919 capsule

Phase 1c，enrolled, eligible patients receive CFT8919 RP2D twice daily.

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • yun fan, PHD · Zhejiang Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-13
Primary Completion
2025-12-09
Completion
2026-04-03

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06641609 on ClinicalTrials.gov