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Phase 1/2 Study of HS-10375 in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)

ConditionAdvanced or Metastatic NSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

HS-10375 is an oral, highly selective, small molecular inhibitor of EGFR C797S. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10375 in Chinese advanced or metastatic NSCLC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men or women greater than or equal to 18 years.

Locally advanced or metastatic NSCLC patients confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable .

Pathological, NSCLC tissue samples can be used to test EGFR C797S mutation by central laboratory for Phase 1b and Phase II subjects.

At least one measurable lesion in accordance with RECIST 1.1.

Disqualifiers

Previous or current treatment with EGFR C797S inhibitors.

Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10375.

Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10375.

Local radiotherapy for palliation within 2 weeks of the first dose of HS-10375, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10375.

Trial design

Design model

Sequential

Treatments tested in this trial

  • HS-10375

    Drug

    HS-10375 will be administered orally once daily in a continuous regimen

Treatment groups

354 Participants
are divided into 1 treatment group
Group A: HS-10375Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To determine the maximum tolerated dose (MTD)-Part Ia

Number of participants with dose limiting toxicity

Time frame
From the single dose to the last dose of the first cycle defined as 21 days of multiple dosing (28 days)
2

To evaluate clinical activity/efficacy of HS-10375 by assessment of objective response rate-Part Ib/II

Objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

Time frame
Time Frame: up to 24 months

Secondary outcomes

1

Number of participants with treatment related adverse events

Number of participants with treatment related adverse events

Time frame
From baseline until 28 days after the last dose
2

Observed maximum plasma concentration (Cmax) after single dose of HS-10375

In the study of single-dose, Cmax will be obtained following administration of a single oral dose of HS-10375

Time frame
From pre-dose to 120 hours after single dose on Day 1
3

Time to reach maximum plasma concentration (Tmax) after single dose of HS-10375

In the study of single-dose, Tmax will be obtained following administration of a single oral dose of HS-10375

Time frame
From pre-dose to 120 hours after single dose on Day 1
4

Apparent terminal half-life (T1/2) after single dose of HS-10375

Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz

Time frame
From pre-dose to 120 hours after single dose on Day 1

Other outcomes

Sponsors and contacts

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

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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