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A Phase I Study of CFT8919 in Patients With Advanced NSCLC

ConditionNon-Small Cell Lung Cancer With EGFR Mutation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBetta Pharmaceuticals Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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).

• Dose-Escalation Phase requires evaluable lesions, while Dose-Expansion and Cohort-Expansion Phases require measurable lesions as defined by RECIST V1.1.

Disqualifiers

Prior or ongoing treatment with EGFR-L858R-targeted PROTAC therapies.

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.

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.

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Dose-Escalation (Phase Ia) CFT8919 capsule

    Drug

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

  • Dose-Expansion (Phase Ib) CFT8919 capsule

    Drug

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

  • Cohort-Expansion (Phase Ic) CFT8919 capsule

    Drug

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

Treatment groups

166 Participants
are divided into 3 treatment groups
Group A: Dose-Escalation (Phase Ia)Experimental treatment 1 intervention
Group B: Dose-Expansion (Phase Ib)Experimental treatment 1 intervention
Group C: Cohort-Expansion (Phase Ic)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

The percentage of participants who achieve a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.

Time frame
up to 104 weeks
2

Maximum Tolerated Dose (MTD)

The highest dose at which no more than one of six participants experiences dose-limiting toxicity (DLT).

Time frame
Determined at the end of the dose-escalation phase，an average of 1 year
3

Recommended Phase II Dose (RP2D)

The dose selected for Phase II studies based on safety, tolerability, and efficacy data.

Time frame
Determined at the end of the dose-expansion，an average of 2 years

Secondary outcomes

1

Dose-Limiting Toxicities (DLTs)

The occurrence of adverse events that prevent further dose escalation.

Time frame
At the end of Cycle 1 (each cycle is 28 days)
2

Safety and Tolerability

Assessed by the frequency, type, and severity of adverse events (AEs) and serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Time frame
From the start of treatment until 28 days after the last dose
3

Peak Plasma Concentration (Cmax)

The maximum observed concentration of the drug in plasma.

Time frame
Up to approximately 30 months
4

Time to Reach Maximum Concentration (Tmax)

The time at which Cmax is observed

Time frame
Up to approximately 30 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Betta Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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