NCT06641609

A Phase I Study of CFT8919 in Patients With Advanced NSCLC

Not yet recruiting Phase 1 Last updated 15 October 2024

What this trial tests

Phase 1 trial testing Dose-Escalation (Phase Ia) CFT8919 capsule in Non-Small Cell Lung Cancer With EGFR Mutation in 166 participants. Not yet recruiting.

Timeline

13 December 2024

Primary endpoint
9 December 2025

3 April 2026

Quick facts

Lead sponsor	Betta Pharmaceuticals Co., Ltd.
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	166
Start date	13 December 2024
Primary completion	9 December 2025
Estimated completion	3 April 2026
Sites	1 location across China

Drugs / interventions tested

• Dose-Escalation (Phase Ia) CFT8919 capsule — full drug profile →
• Dose-Expansion (Phase Ib) CFT8919 capsule — full drug profile →
• Cohort-Expansion (Phase Ic) CFT8919 capsule — full drug profile →

Conditions studied

• Non-Small Cell Lung Cancer With EGFR Mutation — all drugs for Non-Small Cell Lung Cancer With EGFR Mutation →

Sponsor

Betta Pharmaceuticals Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer With EGFR Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. PROTAC Delivery Strategies for Overcoming Physicochemical Properties and Physiological Barriers in Targeted Protein Degradation.
   Syahputra EW, Lee H, Cho H, Park HJ, et al · · 2025 · cited 20× · PMID 40284496 · DOI 10.3390/pharmaceutics17040501
2. Strategies Beyond 3rd EGFR-TKI Acquired Resistance: Opportunities and Challenges.
   Zhou X, Zeng L, Huang Z, Ruan Z, et al · · 2025 · cited 9× · PMID 40322930 · DOI 10.1002/cam4.70921
3. Proteolysis-Targeting Chimera (PROTAC): Current Applications and Future Directions.
   Fan G, Chen S, Zhang Q, Yu N, et al · · 2025 · cited 6× · PMID 41049269 · DOI 10.1002/mco2.70401
4. EGFR molecular degraders: preclinical successes and the road ahead.
   Rallabandi NC, Panpatil D, Gahtory D, Navik U, et al · · 2025 · cited 1× · PMID 39928493 · DOI 10.1080/17568919.2025.2463871
5. Fine-Tuning Protein Fate: Mechanisms of E1, E2, and E3 Enzymes and Deubiquitinases in Cell Signaling.
   Kim Y, Kim EK, Jang HH. · · 2026 · PMID 42074047 · DOI 10.3390/ijms27083404
6. Mechanisms and Design Principles of Proteolysis-Targeting Chimeras and Their Emerging Applications.
   Knoll N, Neamati N, Üren A. · · 2026 · PMID 41988372 · DOI 10.1021/acsptsci.5c00730
7. PROTACs in cancer therapy: targeted degradation of GPX4, PARP and epigenetic regulators.
   Periyasamy S, Jarrett T, Truong J, Skouta R. · · 2026 · PMID 41885448 · DOI 10.1080/14756366.2026.2636394