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Advanced Solid TumorPhase 1NCT05378178

A PhaseⅠStudy of HS-10381 in Patients With Advanced Solid Tumors

A Phase 1 study testing HS-10381 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 The sponsor has not verified this record for over two years, so it may be out of date.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-10381 is a small molecular, oral potent, SHP2 inhibitor. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-10381 in Patients With Advanced Solid Tumors. 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-10381
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteChina
Study dates
8 Jun 2022to 31 Dec 2024
Phase
Phase 1
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

  • Men or women aged more than or equal to (≥) 18 years
  • Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable
  • Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required)
  • ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
  • Estimated life expectancy greater than (>) 12 weeks
  • Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have evidence of non-childbearing potential
  • Sign Informed Consent Form

Who cannot join

  • Treatment with any of the following:
  • Previous or current treatment with drugs targeting SHP2
  • Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug
  • Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
  • Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
  • Known and untreated, or active central nervous system metastases.
Show all 13Show fewer
  • Existing abnormal CTCAE≥grade 2 resulted from previous treatment
  • History of other malignancy
  • Inadequate bone marrow reserve or organ function
  • Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured, Known history of HIV
  • History of hypersensitivity to any active or inactive ingredient of HS-10381.
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
  • Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.

Trial locations and contacts

1 site in 1 country.

You Lu, PhD contact

18980601763

radyoulu@hotmail.com

China1 site, 1 recruiting

  • West China Hospital of Sichuan University

    Xi’an, Sichuan, 610044

    You Lu, PhD, 18980601763, radyoulu@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10381 in Patients With Advanced Solid Tumors

HS-10381 is a small molecular, oral potent, SHP2 inhibitor. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-10381 in Patients With Advanced Solid Tumors.

Read the detailed description

This is a Phase 1 open-label, multicenter study to evaluate the safety, tolerability, PK and preliminary efficacy of HS-10381 in patients with advanced solid tumors by using a "3+3" dose escalation.

Being tested
HS-10381
Keywords
HS-10381, SHP2, Advanced Solid Tumor

What participants receive

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

  • HS-10381Drug

    Each subject will receive a single dose(C0) of HS-10381 and then repeat doses(C1, C2…) for 21-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

Study groups in NCT05378178
Study groupRoleWhat they receive
Phase I：Dose escalationExperimentalHS-10381 given orally QD of various dose strengths administered in 21 day dosing cycles.
Receives: Drug: HS-10381

What is being measured

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

  1. Maximum Tolerated Dose of HS-10381

    To determine the MTD of HS-10381 in subjects with advanced solid tumors.

    Measured: 4 weeks after initiation of treatment

Secondary outcomes (8)

  1. Incidence and severity of treatment-emergent adverse events

    The CTCAE criteria will be used to assess adverse events on this trial.

    Measured: Baseline through study completion(28 days after last dose)

  2. Observed maximum plasma concentration (Cmax) after single dose of HS-10381

    Cmax will be obtained after single dose of HS-10381 on Cycle 0 Day 1.

    Measured: From pre-dose to 120 hours after single dose on Cycle 0 Day 1.

  3. Observed maximum plasma concentration (Cmax ss) after multiple dose of HS-10381

    Cmax ss will be obtained on Cycle 2 Day 1.

    Measured: From pre-dose to 24 hours after the dose on Cycle 2 Day 1

  4. Apparent terminal half-life (t1/2) after single dose of HS-10381

    Apparent terminal half-life is the time measured for the concentration to decrease by one half.

    Measured: From pre-dose to 120 hours after single dose on Cycle 0 Day 1

  5. Area under plasma concentration versus time curve from zero to the 24-hour sampling time (AUC0-24) after single dose of HS-10381

    Area under the plasma concentration versus time curve from time zero to the 24-hour sampling time at which the concentration was at or above the lower limit of quantification (LLQ).

    Measured: From pre-dose to 24 hours after single dose on Cycle 0 Day 1

  6. Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) after single dose of HS-10381

    Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ).

    Measured: From pre-dose to 120 hours after single dose on Cycle 0 Day 1

  7. Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-10381

    AUC0-∞ was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.

    Measured: From pre-dose to 120 hours after single dose on Cycle 0 Day 1

  8. To further evaluation of the anti-tumor activity of HS-10381 by assessment of objective response rate (ORR)

    Anti-tumor efficacy will be assessed by best radiographic response based on Response Evaluation Criteria in Solid Tumors at baseline (Day -28 to -1). For patients that continue on repeating 21-Day cycles after the primary evaluation period, progression will be assessed after each 6 weeks of therapy. ORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1.

    Measured: From the date of first occurrence of complete response (CR) or partial response (PR) on 2 consecutive occasions (≥4 weeks), until the date of disease progression or withdrawal from study，up to 2 years

Timeline

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

  1. First posted18 May 2022
  2. Study start8 Jun 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05378178
Sponsor's protocol ID
HS-10381-101
Status last verified
Jul 2022
First submitted
6 May 2022
Last updated
7 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-10381 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 7 inclusion and 13 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 7 Jul 2022. 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 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.

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 You Lu, PhD (18980601763, radyoulu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose of HS-10381 (time frame: 4 weeks after initiation of treatment). 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 NCT05378178.

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 7 Jul 2022.

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