A Single-Arm, Multi-Centre, Open-Label Phase II Study of HA121-28 in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country83 target enrollmentFebruary 18, 2022

ConditionsNSCLC

InterventionsHA121-28 tablet

DrugsHA121-28 tablet

Overview

Phase: Phase 2
Intervention: HA121-28 tablet
Conditions: NSCLC
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Enrollment: 83
Locations: 1
Primary Endpoint: Objective Response Rate (ORR)
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy and safety of HA121-28 tablets in patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC).

Registry

clinicaltrials.gov

Start Date

February 18, 2022

End Date

October 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily participate in this study and sign the informed consent form;
•Aged 18 \~ 75 years old (inclusive), male or female;
•Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer;
•RET gene fusion, as demonstrated by "Next-generation" sequencing(NGS) method in central laboratory with College of American Pathologists(CAP) or Clinical Laboratory Improvement Amendments(CLIA) certification;
•Progressive disease after at least one line of standard therapy (including patients with disease progression during or within 6 months of the end of adjuvant therapy);
•At least one measurable lesion according to RECIST 1.1 (for lesions previously treated with radiation, the lesion can be included as a measurable lesion only if there is clear disease progression after radiotherapy);
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1;
•Adequate organ function, laboratory tests meeting the following criteria:
•Neutrophil count (ANC) ≥ 1.5 × 10\^9/L (no G-CSF for WBC-elevating therapy within 2 weeks prior to the laboratory test);
•Platelet count (PLT) ≥ 75 × 10\^9/L (no platelet transfusion or other drugs to promote platelet production within 2 weeks prior to the laboratory test);

Exclusion Criteria

•Had a documented oncogenic driver gene alteration other than RET in NSCLC, ie, activating EGFR, BRAF, or KRAS mutation, MET exon 14 skipping mutation or high-level amplification, and ALK, ROS1, or NTRK1/2/3 gene fusions;
•Prior treatment with selective RET inhibitors (including investigational selective RET inhibitors, such as LOXO-292, BLU-667, RXDX-105, etc.);
•Patients who previously received any anti-tumor therapy (including but not limited to chemotherapy, radiotherapy and targeted therapy, etc.) within 4 weeks before the first use of the study drug; traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 2 weeks; local palliative radiotherapy for the relief of bone metastasis pain within 2 weeks;
•Abnormal coagulation function (INR \> 1.5 or APTT \> 1.5 × ULN); patients with bleeding tendency (such as active peptic ulcer) or receiving thrombolytic or anticoagulant therapy;
•Urine routine showed urine protein ≥ + + and 24 h urine protein \> 1.0 g;
•Patients who have undergone major surgical procedures within 4 weeks before the first dose or are expected to undergo major surgery during the study;
•Patients with central nervous system (CNS) metastases who present with progressive neurological symptoms or require an increase in corticosteroid dose to control their CNS disease. If a patient requires treatment with corticosteroids for CNS disease, the dose must be stable for two weeks prior to the first dose;
•Presence of poorly controlled pericardial, pleural, or peritoneal effusion;
•Interstitial pneumonia requiring steroid therapy, drug-induced pneumonitis, radiation pneumonitis (except for stable radiation pneumonitis);
•Significant cardiovascular disease, such as heart failure greater than New York Heart Association (NYHA) Class 2, unstable angina, serious arrhythmia, myocardial infarction or stroke within 6 months prior to the first dose, poorly controlled hypertension (defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg on multiple measurements while on medication);

Arms & Interventions

HA121-28

Patients will receive HA121-28 tablets at 450 mg once daily (QD) for 21 days on a 28-day treatment cycle.

Intervention: HA121-28 tablet

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

Time Frame: Up to approximately 12 months

The percentage of patients who achieve a complete response (CR) or partial response (PR) evaluated by Independent Review Committee (IRC) according to RECIST 1.1.

Secondary Outcomes

ORR(Up to approximately 12 months)
Progression-Free Survival (PFS)(Up to approximately 12 months)
PFS(Up to approximately 12 months)
Duration of Response (DOR)(Up to approximately 12 months)
DOR(Up to approximately 12 months)
Incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs).(Up to 28 days after the last administration of HA121-28)
Overall survival (OS)(Up to approximately 24 months)
DCR(Up to approximately 12 months)
Disease Control Rate (DCR)(Up to approximately 12 months)