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Advanced Solid TumorPhase 1/2NCT05367778

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

A Phase 1/2 study testing HS-10370 in people with Advanced Solid Tumor, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
HS-10370
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteChina
Study dates
3 Jun 2022to 30 Apr 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
  • Men or women greater than or equal to 18 years
  • Locally advanced or metastatic cancer patients confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable
  • Pathological, tumor tissue samples can be used to test KRAS G12C mutation by central laboratory for Phase 1b subjects.
  • At least one measurable lesion in accordance with RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0~1
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  • 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

Who cannot join

  • Treatment with any of the following:
  • Previous or current treatment with KRAS G12C inhibitors
  • Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10370
  • Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10370
  • 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
  • Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10370
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  • Inadequate bone marrow reserve or serious organ dysfunction
  • Uncontrolled pleural, ascites or pericardial effusion
  • Known and untreated, or active central nervous system metastases
  • Active autoimmune diseases or 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-10370 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10370
  • 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 locations and contacts

1 site in 1 country.

Xiaorong Dong, PhD contact

13986252286

xhzzdxr@126.com

China1 site, 1 recruiting

  • Union Hospital Tong Ji Medical College, HuaZhong University of Science and Technology

    Wuhan, Hubei, 430000

    Xiaorong Dong, PhD, 13986252286, xhzzdxr@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1/2, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10370 Monotherapy in Patients with Advanced Solid Tumors

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.

Being tested
HS-10370
Keywords
Advanced Solid Tumor, KRAS G12C mutation, HS-10370

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-10370Drug

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

Study groups in NCT05367778
Study groupRoleWhat they receive
HS-10370（Phase 1a：Dose Escalation）ExperimentalSubjects with advanced solid tumors will be enrolled in dose escalation cohorts. Dose escalation of HS-10370 will be done to determine maximum tolerated dose.
Receives: Drug: HS-10370
HS-10370（Phase 1b：Dose Expansion ）ExperimentalDepending 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.
Receives: Drug: HS-10370
HS-10370（Phase 2 ）ExperimentalSubjects 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.
Receives: Drug: HS-10370

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number of participants with dose limiting toxicity

    Measured: 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)

    Measured: up to 24 months

Secondary outcomes (8)

  1. Incidence and severity of treatment-emergent adverse events

    Number of participants with treatment related adverse events.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: From pre-dose to 120 hours after single dose on Day 1

  5. Duration of response (DOR)

    DOR assessed by RECIST 1.1 criteria

    Measured: 24 months

  6. Disease Control Rate (DCR)

    DCR assessed by RECIST 1.1 criteria

    Measured: 24 months

  7. Progression-free survival (PFS)

    PFS assessed by RECIST 1.1 criteria

    Measured: 24 months

  8. Overall survival (OS)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2022
  2. Study start3 Jun 2022
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05367778
Sponsor's protocol ID
HS-10370-101
Status last verified
Sep 2024
First submitted
5 May 2022
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HS-10370 in people with Advanced Solid Tumor, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaorong Dong, PhD (13986252286, xhzzdxr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ia：To determine the maximum tolerated dose (MTD) (time frame: From the single dose to the last dose of the first cycle defined as 21 days of multiple dosing (28 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05367778.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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