RAS-mutant Advanced Solid TumorsPhase 1/2GST101-001NCT07868172
GST101 in Participants With RAS-Mutant Advanced Solid Tumors
A Phase 1/2 study testing GST101 in people with RAS-mutant Advanced Solid Tumors, run by Genuine Seed Therapeutics (Zhuhai) Co., Ltd. at 8 sites in China.
Trial summary
This is an open-label, multicenter Phase I/II trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of oral GST101 in adult participants with RAS-mutant advanced solid tumors. Phase I consists of dose escalation and dose-expansion parts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RAS-mutant Advanced Solid Tumors
- What is being tested?
- GST101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 8 sitesChina
- Study dates
- 30 Oct 2026to Oct 2028
- 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
- Aged ≥18 years, male or female, with signed informed consent.
- Histologically or cytologically confirmed RAS-mutated advanced solid tumor, with disease progression or intolerance to standard anti-tumor therapy, or no available standard treatment.
- For Phase II cohorts: eligible RAS-mutated advanced NSCLC, colorectal cancer, pancreatic cancer or other solid tumors meeting corresponding line-of-treatment criteria.
- ECOG performance status 0 or 1.
- Estimated life expectancy ≥ 3 months.
- At least one measurable lesion per RECIST 1.1.
- Adequate hematological, hepatic and renal organ function without supportive treatment within 14 days before dosing, meeting prespecified laboratory thresholds.
- Fertile participants agree to effective contraception from consent to 4 months after last dose; female participants have negative pregnancy test and no lactation at baseline.
Who cannot join
- Symptomatic or uncontrolled central nervous system metastases, spinal cord compression or meningeal carcinomatosis.
- Active or previous malignant tumor within 5 years (except permitted low-risk in-situ or superficial tumors).
- Uncontrolled large-volume serous cavity effusion.
- Active HIV, hepatitis B/C, syphilis or tuberculosis infection.
- History of allogeneic organ or stem cell transplantation.
- Severe uncontrolled cardiovascular, pulmonary, hepatic, renal, neurological or metabolic diseases within 6 months prior to enrollment.
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- QTcF >480 ms, long QT syndrome, reduced left ventricular ejection fraction or uncontrolled severe arrhythmia/hypertension.
- Severe cutaneous adverse drug reaction history or uncontrolled electrolyte/metabolic disorders.
- High bleeding risk, active gastrointestinal bleeding or recent venous thromboembolism within 6 months.
- Hypersensitivity to study drug or excipients.
- Pregnancy, lactation, uncontrolled psychiatric disorder or substance abuse.
- Prior treatment with any RAS-targeted inhibitor.
- Receipt of prohibited anti-tumor drugs, strong CYP3A modulators within required washout periods before dosing.
- Unresolved >Grade 1 toxicity from prior anti-tumor therapy.
- Impaired oral drug absorption or inability to take oral medication.
- High-risk QTc factors and prohibited medications for QTc assessment subpopulation.
- Major surgery within 4 weeks before enrollment or planned surgery during study period.
- Any other condition considered inappropriate for study enrollment by the investigator.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Li Zheng, +86 028-85423655, 18980601950@163.com
Lu Li
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zhengbo Song, +86 0571-88122268, songzb@zjcc.orj.cn
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yanqiao Zhang, +86 0451-86298220, yanqiaozhanggcp@163.com
- Not yet recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Yan Zhang, +86 0531-67627157, zhangyan0681@163.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xianjun Yu, MD, PhD, +86 021-64175590, yuxianjun@fudanpci.org
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Caicun Zhou, MD, PhD, +86 021-58822171, caicunzhoudr@163.com
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Fengying Wu, +86 021-65115006, fywu@163.com
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Xinjun Liang, +86 027-87670003, Doctorlxj@163.com
About this study
Official title: A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GST101 in Participants With RAS-Mutant Advanced Solid Tumors
This is an open-label, multicenter Phase I/II trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of oral GST101 in adult participants with RAS-mutant advanced solid tumors.
Phase I consists of dose escalation and dose-expansion parts. Dose escalation uses accelerated titration design combined with 3+3 design to determine maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). Safety, dose-limiting-toxicity (DLT), PK and preliminary efficacy will be assessed.
Read more
Phase II (indication-exploration) enrolls participants in four tumor-specific cohorts including RAS-mutant NSCLC, colorectal cancer, pancreatic ductal adenocarcinoma and other advanced solid tumors refractory to standard-of-care therapies.
Participants receive GST101 orally once-daily in 21-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or loss of clinical benefit. Tumor assessments follow RECIST 1.1. Safety, PK, QTc and exploratory biomarker analyses will be performed.
- Conditions
- RAS-mutant Advanced Solid Tumors
- Being tested
- GST101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GST101Drug
5 mg oral tablet, administered once daily. Participants are assigned to different dose-level cohorts (10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 100 mg). Fasting requirement: 1-hour fast prior to dosing and 2-hour fast after dosing. Each treatment cycle is 21-days. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or no further clinical benefit.
| Study group | Role | What they receive |
|---|---|---|
| GST101 Monotherapy | Experimental | Participants receive oral GST101 once-daily in 21-day treatment cycles. Multiple dose levels (10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 100 mg) are evaluated in sequential dose-escalation cohorts using accelerated titration design (ATD) combined with a 3+3 design. Selected safe doses will enter dose-expansion. Phase II indication-exploration cohorts will adopt the recommended Phase II dose (RP2D) determined from Phase I. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or loss of clinical benefit. Participants are required to fast for 1-hour before dosing and 2-hours after dosing. Receives: Drug: GST101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-Limiting Toxicity (DLT)
The number of participants experiencing dose-limiting toxicities (DLT) during the dose-escalation period of the study.
Measured: At the end of Cycle 1 (each cycle is 21 days)
Incidence and Severity of Treatment-Emergent Adverse Events (AEs) and Serious AEs
The incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including abnormalities in laboratory values and vital signs.
Measured: Up to 36 months
Maximum Tolerated Dose (MTD)
To determine the maximum tolerated dose of GST101
Measured: Up to 12 months
Recommended Phase 2 Dose (RP2D)
To determine the recommended phase 2 dose of GST101
Measured: Up to 12 months
Objective Response Rate (ORR)
Objective response rate (ORR) as assessed by the investigator per RECIST v1.1
Measured: Up to 36 months
Secondary outcomes (8)
Duration of Response (DOR)
Duration of response (DoR) as assessed by investigator per RECIST v1.1
Measured: Up to 36 months
Disease Control Rate (DCR)
Disease control rate (DCR) as assessed by investigator per RECIST v1.1
Measured: Up to 36 months
Progression-Free Survival (PFS)
Progression-free survival (PFS) as assessed by the investigator per RECIST v1.1
Measured: Up to 36 months
Overall Survival (OS)
Measured: Up to 36 months
Maximum Observed Blood Concentration (Cmax) of GST101
Measured: Up to 36 weeks
Time to Reach Maximum Blood Concentration (Tmax) of GST101
Measured: Up to 36 weeks
Area Under the Concentration-time Curve （AUC) of GST101
Measured: Up to 36 weeks
Elimination Half-Life (t1/2) of GST101
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start30 Oct 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RAS-mutant Advanced Solid TumorsStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genuine Seed Therapeutics (Zhuhai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, MD, PhD, Study chair, Shanghai East HospitalXianjun Yu, MD, PhD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868172
- Sponsor's protocol ID
- GST101-001
- Acronym
- GST101-001
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share de-identified individual participant data (IPD) publicly. Patient-level sensitive health information cannot be publicly released under local privacy regulations, hospital ethics committee requirements, and informed consent provisions. Summary aggregated study results may be published in peer-reviewed journals. Academic collaboration requests may be submitted to the sponsor for consideration under a formal data-use agreement upon ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GST101 in Participants With RAS-Mutant Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07868172
- Acronym / sponsor ID
- GST101-001 / GST101-001
- Conditions
- RAS-mutant Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Genuine Seed Therapeutics (Zhuhai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 9 Oct 2026 (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 an open-label, multicenter Phase I/II trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of oral GST101 in adult participants with RAS-mutant advanced solid tumors.
Phase I consists of dose escalation and dose-expansion parts. Dose escalation uses accelerated titration design combined with 3+3 design to determine maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). Safety, dose-limiting-toxicity (DLT), PK and preliminary efficacy will be assessed.
Phase II (indication-exploration) enrolls participants in four tumor-specific cohorts including RAS-mutant NSCLC, colorectal cancer, pancreatic ductal adenocarcinoma and other advanced solid tumors refractory to standard-of-care therapies.
Participants receive GST101 orally once-daily in 21-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or loss of clinical benefit. Tumor assessments follow RECIST 1.1. Safety, PK, QTc and exploratory biomarker analyses will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GST101 Monotherapy | Experimental | Drug: GST101Participants receive oral GST101 once-daily in 21-day treatment cycles. Multiple dose levels (10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 100 mg) are evaluated in sequential dose-escalation cohorts using accelerated titration design (ATD) combined with a 3+3 design. Selected safe doses will enter dose-expansion. Phase II indication-exploration cohorts will adopt the recommended Phase II dose (RP2D) determined from Phase I. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or loss of clinical benefit. Participants are required to fast for 1-hour before dosing and 2-hours after dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥18 years, male or female, with signed informed consent.
- Histologically or cytologically confirmed RAS-mutated advanced solid tumor, with disease progression or intolerance to standard anti-tumor therapy, or no available standard treatment.
- For Phase II cohorts: eligible RAS-mutated advanced NSCLC, colorectal cancer, pancreatic cancer or other solid tumors meeting corresponding line-of-treatment criteria.
- ECOG performance status 0 or 1.
- Estimated life expectancy ≥ 3 months.
Key exclusion criteria (18 listed)
- Symptomatic or uncontrolled central nervous system metastases, spinal cord compression or meningeal carcinomatosis.
- Active or previous malignant tumor within 5 years (except permitted low-risk in-situ or superficial tumors).
- Uncontrolled large-volume serous cavity effusion.
- Active HIV, hepatitis B/C, syphilis or tuberculosis infection.
- History of allogeneic organ or stem cell transplantation.
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 |
|---|---|---|
| GST1015 mg oral tablet, administered once daily. Participants are assigned to different dose-level cohorts (10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 100 mg). Fasting requirement: 1-hour fast prior to dosing and 2-hour fast after dosing. Each treatment cycle is 21-days. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or no further clinical benefit. | Drug | GST101 Monotherapy |
Primary outcome
Number of Participants with Dose-Limiting Toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
The number of participants experiencing dose-limiting toxicities (DLT) during the dose-escalation period of the study.
Incidence and Severity of Treatment-Emergent Adverse Events (AEs) and Serious AEs
Time frame: Up to 36 months
The incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including abnormalities in laboratory values and vital signs.
Maximum Tolerated Dose (MTD)
Time frame: Up to 12 months
To determine the maximum tolerated dose of GST101
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 12 months
To determine the recommended phase 2 dose of GST101
Objective Response Rate (ORR)
Time frame: Up to 36 months
Objective response rate (ORR) as assessed by the investigator per RECIST v1.1
8 secondary outcomes
Duration of Response (DOR)
Time frame: Up to 36 months
Disease Control Rate (DCR)
Time frame: Up to 36 months
Progression-Free Survival (PFS)
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 months
Maximum Observed Blood Concentration (Cmax) of GST101
Time frame: Up to 36 weeks
Time to Reach Maximum Blood Concentration (Tmax) of GST101
Time frame: Up to 36 weeks
Area Under the Concentration-time Curve （AUC) of GST101
Time frame: Up to 36 weeks
Elimination Half-Life (t1/2) of GST101
Time frame: Up to 36 weeks
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 6 Nov 2026.
- Individual participant dataSharing planned: No. There are no plans to share de-identified individual participant data (IPD) publicly. Patient-level sensitive health information cannot be publicly released under local privacy regulations, hospital ethics committee requirements, and informed consent provisions. Summary aggregated study results may be published in peer-reviewed journals. Academic collaboration requests may be submitted to the sponsor for consideration under a formal data-use agreement upon ethical approval.
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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.
Caicun Zhou, MD, PhD study chair
Shanghai East Hospital
Xianjun Yu, MD, PhD study chair
Fudan University
8 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 GST101 in people with RAS-mutant Advanced Solid Tumors, run by Genuine Seed Therapeutics (Zhuhai) Co., Ltd. at 8 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 8 inclusion and 18 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 Xiaoli Shi, MMed (+86 18701056862, xiaoli.shi@gseedtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose-Limiting Toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 5 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 6 Nov 2026.