SafetyPhase 1/2NCT06243354
Phase 1/2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation
A Phase 1/2 study testing Test product: HYP-2090PTSA in people with Safety and Tolerability, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 6 sites in China.
Trial summary
This is a multicenter, open-label phase 1/2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety, Tolerability, Efficacy
- What is being tested?
- Test product: HYP-2090PTSA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 6 sitesChina
- Study dates
- 4 Feb 2024to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed;
- 18 Years and older;
- Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors;
- Subjects must have at least one measurable lesion as defined by RECIST v1.1;
- Eastern Cooperative Oncology Group(ECOG) performance status 0-1;
- Expected survival ≥ 3 months;
- Patients are willing to use a highly effective method of birth control during the study, and for at least 180 days after the last dose of study medication.
Who cannot join
- Patients who have received major surgical or interventional treatment within 4 weeks prior to the first dose, with the exception of tumor biopsy, puncture, etc. Patients who have received anti-tumor therapy (radiotherapy, immunologic therapy or biological therapy) within 4 weeks, prior to the first dose, or received small molecular targeted therapy, chemotherapy within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks;
- Patients who have received live vaccines within 4 weeks prior to the first dose;
- Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose;
- Patients with a history of central nervous system disease within 12 months prior to enrollment, such as seizures, cerebral vascular embolism/hemorrhage, paralysis, aphasia, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric disease, or any autoimmune disease with involvement of the central nervous system;
- Presence of severe pulmonary diseases such as pulmonary embolism, interstitial lung disease at screening;
- Patients who have previously received allogeneic tissue/solid organ transplantation;
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- Patients with active infection;
- Patients who are positive for human immunodeficiency virus (HIV) (HIV1/2 antibody), positive treponema pallidum antibody (positive treponema pallidum antibody is required to undergo a confirmatory test, and those with negative confirmatory test can be enrolled), active chronic hepatitis B (HBsAg positive and HBV DNA > 500 IU/mL) or active hepatitis C (HCV antibody positive and HCV-RNA > lower limit of detection by the research center);
- Female subjects who are lactating or have a positive blood/urine pregnancy result during the screening period;
- Any other condition of the subject (e.g., mental, geographical, or medical condition) that does not allow him or her to comply with the study and follow-up procedures, or other conditions that, in the judgment of the investigator, the subject is not suitable for inclusion in this study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Hunan Provincial Cancer Hospital
Changsha, Hunan, 410000
Lin Wu, Professor
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
Meng Qiu, Professor
- Recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350000
Yigui Chen, Professor
- Not yet recruiting
Shandong Provincial Cancer Hospital
Jinan, Shandong, 250000
Qi Dang, Professor
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000
Caicun Zhou, Professor
- Not yet recruiting
The first Hospital of China Medical University
Shenyang, Liaoning, 110000
Mingfang Zhao, Professor
About this study
Official title: An Open-label, Multi-center, Multi-cohort, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HYP-2090PTSA in Patients With Advanced Solidt Tumors Harboring KRAS Mutation
This is a multicenter, open-label phase 1/2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.
- Conditions
- Safety, Tolerability, Efficacy
- Being tested
- Test product: HYP-2090PTSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product: HYP-2090PTSADrug
Dosage form: Capsule. Strength: 2.5 mg, 5 mg and 10mg. Method of administration: Take orally on an empty stomach. Do not chew. Swallow the product with warm water.
Dose Escalation Phase PK Lead-in Period (C0D1 only): Take once (QD dosing regimen only). Starting from C1D1, and in the Dose Expansion part, subjects will take the protocol-specified dose of HYP-2090PTSA orally in the morning on an empty stomach and one hour before the evening meal (evening dosing applies to BID regimen only), administered once to twice daily or two to three times per week. The administration dosages are: QD (once daily); BID (twice daily); TIW (on Days 1, 3, and 5 of each week); BIW (on Days 1 and 4 of each week).
Avoid drinking water as much as possible within 1 hour before and after dosing (except for the water taken with the medication).
Do not re-administer the dose if vomiting occurs after drug intake.
| Study group | Role | What they receive |
|---|---|---|
| Test product-HYP-2090PTSA | Experimental | Not described Receives: Drug: Test product: HYP-2090PTSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase-2 dose (RP2D)
RP2D should be selected based on a comprehensive assessment of maximum Tolerated dose (MTD), toxicity, pharmacokinetic (PK) profile, and efficacy data
Measured: Approximately 2 years
Number of participants with dose limiting toxicities
Dose-limiting toxicity (DLT) is defined as an adverse event (AE) or clinically Significant abnormal laboratory value occurring in DLT assessment period
Measured: 24 days
Secondary outcomes (3)
Number of participants with Adverse Events (AEs)
All patients participating in this study will be assessed for incidence and severity of AEs and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imagings and ophthalmological assessments
Measured: Approximately 2 years
Objective response rate (ORR)
ORR is defined as the proportion of participants with confirmed complete response or partial response
Measured: Approximately 2 years
Progression-free survival (PFS)
Period of time from the start of treatment to tumor progression or death from any cause (whichever occurs first) based on RECIST v1.1
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start4 Feb 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by Sichuan Huiyu Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 257 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243354
- Sponsor's protocol ID
- HY0002-101
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Multi-cohort, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HYP-2090PTSA in Patients With Advanced Solidt Tumors Harboring KRAS Mutation
- ClinicalTrials.gov ID
- NCT06243354
- Acronym / sponsor ID
- HY0002-101
- Conditions
- Safety, Tolerability, Efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 257 participants (estimated)
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label phase 1/2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test product-HYP-2090PTSA | Experimental | Drug: Test product: HYP-2090PTSA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed;
- 18 Years and older;
- Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors;
- Subjects must have at least one measurable lesion as defined by RECIST v1.1;
- Eastern Cooperative Oncology Group(ECOG) performance status 0-1;
Key exclusion criteria (10 listed)
- Patients who have received major surgical or interventional treatment within 4 weeks prior to the first dose, with the exception of tumor biopsy, puncture, etc. Patients who have received anti-tumor therapy (radiotherapy, immunologic therapy or biological therapy) within 4 weeks, prior to the first dose, or received small molecular targeted therapy, chemotherapy within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks;
- Patients who have received live vaccines within 4 weeks prior to the first dose;
- Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose;
- Patients with a history of central nervous system disease within 12 months prior to enrollment, such as seizures, cerebral vascular embolism/hemorrhage, paralysis, aphasia, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric disease, or any autoimmune disease with involvement of the central nervous system;
- Presence of severe pulmonary diseases such as pulmonary embolism, interstitial lung disease at screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test product: HYP-2090PTSADosage form: Capsule. Strength: 2.5 mg, 5 mg and 10mg. Method of administration: Take orally on an empty stomach. Do not chew. Swallow the product with warm water. Dose Escalation Phase PK Lead-in Period (C0D1 only): Take once (QD dosing regimen only). Starting from C1D1, and in the Dose Expansion part, subjects will take the protocol-specified dose of HYP-2090PTSA orally in the morning on an empty stomach and one hour before the evening meal (evening dosing applies to BID regimen only), administered once to twice daily or two to three times per week. The administration dosages are: QD (once daily); BID (twice daily); TIW (on Days 1, 3, and 5 of each week); BIW (on Days 1 and 4 of each week). Avoid drinking water as much as possible within 1 hour before and after dosing (except for the water taken with the medication). Do not re-administer the dose if vomiting occurs after drug intake. | Drug | Test product-HYP-2090PTSA |
Primary outcome
Recommended phase-2 dose (RP2D)
Time frame: Approximately 2 years
RP2D should be selected based on a comprehensive assessment of maximum Tolerated dose (MTD), toxicity, pharmacokinetic (PK) profile, and efficacy data
Number of participants with dose limiting toxicities
Time frame: 24 days
Dose-limiting toxicity (DLT) is defined as an adverse event (AE) or clinically Significant abnormal laboratory value occurring in DLT assessment period
3 secondary outcomes
Number of participants with Adverse Events (AEs)
Time frame: Approximately 2 years
Objective response rate (ORR)
Time frame: Approximately 2 years
Progression-free survival (PFS)
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Test product: HYP-2090PTSA in people with Safety and Tolerability, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 6 sites 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 10 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: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Chang (+86-028-86021875, kai.chang4086@huiyupharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended phase-2 dose (RP2D) (time frame: Approximately 2 years). 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?
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 29 Jan 2026.