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Status unknownNCT05367778Updated Sep 19, 2024

Phase 1/2 Study of HS-10370 in Patients with Advanced Solid Tumors

A Phase 1/2 interventional study of HS-10370 in Advanced Solid Tumor, sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. (part of Hansoh Pharmaceutical Group Company Limited) · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
176
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

HS-10370 is an oral, highly selective, small molecular inhibitor of KRAS G12C. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10370 in Chinese advanced solid tumor patients.

Read the detailed description

This is a phase 1/2, first-in-human, open-label, multicenter study of HS-10370, 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-10370 in subjects with advanced solid tumors and evaluate the preliminary efficacy of HS-10370. Phase 2 will be conducted to evaluate the efficacy of HS-10370 in subjects with locally advanced or metastatic NSCLC with a KRAS G12C mutation.

02

Conditions studied

  • Advanced Solid Tumor

Keywords

  • Advanced Solid Tumor
  • KRAS G12C mutation
  • HS-10370
03

In context

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. is the lead sponsor of 135 studies on the registry; 71 are open to participants now.

Browse Jiangsu Hansoh Pharmaceutical Co., Ltd. studies →All Hansoh Pharmaceutical Group Company Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:

  1. Men or women greater than or equal to 18 years
  2. Locally advanced or metastatic cancer patients confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable
  3. Pathological, tumor tissue samples can be used to test KRAS G12C mutation by central laboratory for Phase 1b subjects.
  4. At least one measurable lesion in accordance with RECIST 1.1
  5. Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1
  6. Estimated life expectancy >12 weeks
  7. 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.
  8. Females must have the evidence of non-childbearing potential
  9. Signed and dated Informed Consent Form

Exclusion criteria

Exclusion Criteria:

  1. Treatment with any of the following:

    1. Previous or current treatment with KRAS G12C inhibitors
    2. Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10370
    3. Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10370
    4. Local radiotherapy for palliation within 2 weeks of the first dose of HS-10370, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10370
    5. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10370
  2. Inadequate bone marrow reserve or serious organ dysfunction
  3. Uncontrolled pleural, ascites or pericardial effusion
  4. Known and untreated, or active central nervous system metastases
  5. Active autoimmune diseases or active infectious disease
  6. Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
  7. History of hypersensitivity to any active or inactive ingredient of HS-10370 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10370
  8. The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator
  9. The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator
  10. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study
  11. History of neuropathy or mental disorders, including epilepsy and dementia
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
176 participants (estimated)

Study arms

  • Experimental
    HS-10370（Phase 1a：Dose Escalation）

    Subjects with advanced solid tumors will be enrolled in dose escalation cohorts. Dose escalation of HS-10370 will be done to determine maximum tolerated dose.

    Drug: HS-10370

  • Experimental
    HS-10370（Phase 1b：Dose Expansion ）

    Depending on data obtained from the dose escalation part, dose expansion may proceed with multiple cohorts in subjects with advanced solid tumors having a KRAS G12C mutation.

    Drug: HS-10370

  • Experimental
    HS-10370（Phase 2 ）

    Subjects with locally advanced or metastatic KRAS G12C mutant NSCLC will be enrolled in phase 2 part to evaluate the efficacy and sufficient safety of HS-10370 as monotherapy.

    Drug: HS-10370

Interventions

  • DrugHS-10370

    HS-10370 will be administered orally once daily in a continuous regimen

06

What researchers measure

Primary outcomes

  1. Phase Ia：To determine the maximum tolerated dose (MTD)

    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. 2. Phase Ib/II: To evaluate clinical activity/efficacy of HS-10370 by assessment of objective response rate

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

    Time frame: up to 24 months

Secondary outcomes

  1. Incidence and severity of treatment-emergent 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-10370

    In the study of single-dose, Cmax will be obtained following administration of a single oral dose of HS-10370 on Day 1 to Day 6

    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-10370

    In the study of single-dose, Tmax will be obtained following administration of a single oral dose of HS-10370 on Day 1 to Day 6.

    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-10370

    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

  5. Duration of response (DOR)

    DOR assessed by RECIST 1.1 criteria

    Time frame: 24 months

  6. Disease Control Rate (DCR)

    DCR assessed by RECIST 1.1 criteria

    Time frame: 24 months

  7. Progression-free survival (PFS)

    PFS assessed by RECIST 1.1 criteria

    Time frame: 24 months

  8. Overall survival (OS)

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Union Hospital Tong Ji Medical College, HuaZhong University of Science and Technology
    Wuhan, Hubei 430000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05367778
Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
May 10, 2022
Start date
Jun 3, 2022
Primary completion
Apr 30, 2025 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Xiaorong Dong, PhD
Contact
xhzzdxr@126.com
13986252286
Xiaorong Dong, PhD
principal investigator · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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