Clinical Trials/NCT04622072

NCT04622072

Terminated

Phase 1

A Single-arm, Open, Multi-center Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Effectiveness of XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Have Progressed After Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI).

Sihuan Pharmaceutical Holdings Group Ltd.5 sites in 1 country21 target enrollmentNovember 2, 2020

ConditionsNon Small Cell Lung Cancer

InterventionsXZP-5809-TT1 Tablet

DrugsXZP-5809-TT1 Tablet

Overview

Phase: Phase 1
Intervention: XZP-5809-TT1 Tablet
Conditions: Non Small Cell Lung Cancer
Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
Enrollment: 21
Locations: 5
Primary Endpoint: adverse event
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The trial is divided into two parts, one is dose escalation phase, the second one is dose expansion phase.

For dose escalation phase, the main purpose is to evaluate safety and tolerability of XZP-5809-TT1 tablets after treatment with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) in patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer, and to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).

For dose expansion phase, the main purpose is to evaluate Objective response rate (ORR) in patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Registry

clinicaltrials.gov

Start Date

November 2, 2020

End Date

April 27, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Sihuan Pharmaceutical Holdings Group Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with locally advanced or metastatic NSCLC who are diagnosed by histology or cytology and are not suitable for surgery or radiotherapy;
•Patients with EGFR sensitive mutations (including deletion of exon 19, L858R mutation of exon 21, at least one of the above mutations) And after the last treatment (regardless of TKI or chemotherapy), the tissue/cytology specimens collected have been passed through a tertiary A hospital or confirmed as T790M+ by the central laboratory;
•The patient's disease progression after the first or/and second-generation EGFR-TKIs treatment (with imaging or pathological evidence, judged by the research center);
•Life expectancy is not less than 12 weeks, ECOG(Eastern Cooperative Oncology Group, ECOG score) is as follows:
•ECOG score in the dose-escalation phase: 0\~1 points, and no deterioration within 2 weeks before enrollment, ECOG score during dose expansion stage: 0\~2 points, and no deterioration within 2 weeks before enrollment;
•According to RECIST 1.1, the patient has at least one imaging (CT/MRI) measurable lesion. When the patient has at least one baseline Tumor lesions meet the following requirements: accurate measurement at baseline, non-lymph node lesions with longest diameter ≥10 mm, or short diameter ≥15 mm Of lymph node lesions. Have not received local treatments such as radiotherapy in the past, and have not been used for research screening biopsy (if there is only one Measurable lesions, biopsy of the lesions is allowed, but the lesions must be performed at least 14 days after the screening biopsy Baseline imaging examination), the measurement method is computed tomography \[CT\] or magnetic resonance imaging \[MRI\]);
•The organ function level must meet the following requirements (no blood transfusion or blood products, no use of hematopoietic stimulating factors, No albumin or blood products are used): absolute neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT)
•≥75×109/L, hemoglobin (Hb) ≥90 g/L; serum total bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) And alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal value (if there is liver metastasis, total bilirubin ≤3 times the upper limit of normal value is allowed, AST, ALT≤5 times the upper limit of normal); Creatinine clearance (Ccr) ≥50 ml/min (according to Cockcroft and Gault formula); Note: If the researcher thinks it is necessary to retest (the reason for the retest must be recorded), the above laboratory examination can only be retested once. complex After the test meets the standard, then the laboratory parameters can be considered qualified.
•Premenopausal women who are likely to have children must have a pregnancy test within 7 days before starting treatment, and the pregnancy test must be negative Sex, must be non-lactating period; infertile women can not take pregnancy test and contraception, but must meet: age 50 Over the age of, not using hormone therapy and menopause for at least 12 months, or have been sterilized. All enrolled patients (regardless of male (Sexual or female) should take adequate barrier contraceptive measures during the entire treatment period and 3 months after the end of treatment;
•Volunteer to join the group and sign the informed consent, follow the trial treatment plan and visit plan.

Exclusion Criteria

•Have received any of the following treatments in the past:
•First medication (first medication refers to the first use of the test drug, hereinafter referred to as the first medication) patient use within 6 weeks Have used nitrosoureas or mitomycin C, or have used other cytotoxic chemotherapeutics or their drugs within 3 weeks before the first administration His anti-cancer drugs;
•The time from receiving any EGRF-TKI treatment to the first dose does not exceed the 5 half-life of the drug (for example, Elotinib is not more than 8 days, gefitinib is not more than 10 days, icotinib is not more than 2 days, and afatinib is not more than 8 days day);
•The time from receiving other experimental drugs or analogues to the first dose does not exceed the drug's 5 half-life or 14 days (whichever Senior citizens);
•The time from receiving other immune preparations to the first administration does not exceed 28 days;
•Major surgery (excluding vascular access establishment surgery and biopsy surgery) within 4 weeks before the first medication;
•The patient has received more than 30% bone marrow radiotherapy or large-area irradiation (excluding bone transfer) within 4 weeks before the first medication.
•Have used third-generation EGFR-TKI drugs, including but not limited to osimertinib mesylate (Teresa®), Rociletinib (CO-1686), Olmutinib (Olita®, HM61713), ASP8273, EGF816, Ametidine mesylate Ni, Iflutinib mesylate (AST2818), Maihuatinib, Ivitinib, etc. or the raw materials and generic drugs of these drugs;
•CYP3A4 strong inhibitors or strong inducers have been used within 7 days before the first administration; CYP3A4 strong inhibitors or strong inducers have been used within 14 days before the first administration Anti-tumor medicines and Chinese medicine preparations, Chinese medicines and Chinese medicine preparations with tumor adjuvant treatment effects, and exclusion criteria Standard 1) Other drugs with anti-tumor activity not mentioned;
•At the beginning of the first medication, there are still unhealed toxic reactions in the previous treatment, and "General Terminology Standards for Adverse Events (CTCAE 5.0)" If the grade exceeds grade 1 (except for hair loss), neuropathy related to previous platinum therapy can be relaxed to grade

Arms & Interventions

Experimental group

For dose escalation phase, subjects are enrolled for different doses of the experimental drug.

Intervention: XZP-5809-TT1 Tablet

Outcomes

Primary Outcomes

adverse event

Time Frame: through study completion, an average of 1.5 year

Refers to adverse clinical events that occur during drug treatment, which may not have a causal relationship with the drug

Objective response rate (ORR)

Time Frame: through study completion, an average of 1.5 year

According to the RECIST 1.1 standard, the best overall response (BOR) observed after enrollment of subjects is the proportion of subjects with complete remission (CR) or partial remission (PR)

Progression-free survival (PFS)

Time Frame: through study completion, an average of 1.5 year

The time from the time a subject receives the first study treatment to the appearance of disease progression or death from any cause (whichever occurs first).

blood routine

Time Frame: through study completion, an average of 1.5 year

the amount of platelet.