Phase 1/2 Study of HS-10376 in Patients With Non-Small Cell Lung Cancer

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Hansoh Pharma

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Advanced Non-Small-Cell Lung Cancer

Treatments

Drug: HS-10376

Study type

Interventional

Funder types

Industry

Identifiers

NCT05435274
HS-10376-101

Details and patient eligibility

About

HS-10376 is an oral, highly selective, small molecular inhibitor of EGFR/HER2 Exon 20 insertion mutation. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10376 in Chinese advanced Non-Small Cell Lung Cancer (NSCLC) patients.

Full description

This is a phase 1/2, first-in-human, open-label, multicenter study of HS-10376, this study has two parts: phase 1 and phase 2. The phase 1 portion consists of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10376 in subjects with advanced NSCLC and evaluate the preliminary efficacy of HS-10376. Phase 2 will be conducted to evaluate the efficacy of HS-10376 in subjects with locally advanced or metastatic NSCLC with a EGFR Exon 20 insertion mutation.

Enrollment

380 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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, tumor tissue samples can be used to test EGFR/HER2 Exon 20 insertion mutation by central laboratory for subjects
  • At least one measurable lesion in accordance with RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0~1
  • Estimated life expectancy >12 weeks
  • Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
  • Females must have the evidence of non-childbearing potential
  • Signed and dated Informed Consent Form

Exclusion criteria

Treatment with any of the following:

  • Previous or current treatment with EGFR Exon 20 insertion inhibitors, HER2 Exon 20 insertion inhibitors or EGFR/HER2 Exon 20 insertion inhibitors
  • Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10376
  • Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10376
  • Local radiotherapy for palliation within 2 weeks of the first dose of HS-10376, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10376
  • Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10376
  • Inadequate bone marrow reserve or serious organ dysfunction
  • Uncontrolled pleural, ascites or pericardial effusion
  • Untreated, symptomatic or active central nervous system metastases
  • Severe or poorly controlled hypertension
  • Immunodeficiency disease and active infectious disease
  • Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
  • History of hypersensitivity to any active or inactive ingredient of HS-10376 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10376
  • The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator
  • The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator
  • Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study
  • History of neuropathy or mental disorders, including epilepsy and dementia

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

380 participants in 1 patient group

HS-10376
Experimental group
Description:
Phase 1a:Dose Escalation:Subjects with advanced NSCLC will be enrolled in dose escalation cohorts. Dose escalation of HS-10376 will be done to determine maximum tolerated dose. Phase 1b:Dose Expansion:Depending on data obtained from the dose escalation part, dose expansion may proceed with multiple cohorts in subjects with advanced NSCLC having a EGFR/HER2 Exon 20 insertion mutation. Phase 2:Subjects with locally advanced or metastatic EGFR Exon 20 insertion NSCLC will be enrolled in phase 2 part to evaluate the efficacy and sufficient safety of HS-10376 as monotherapy.
Treatment:
Drug: HS-10376

Trial contacts and locations

1

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Central trial contact

Dingzhi Huang

Data sourced from clinicaltrials.gov

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