Solid Tumors Harboring a TP53 Y220C MutationPhase 1NCT06908434
A Phase I First-in-Human Study of GenSci128 in Patients With Solid Tumors Harboring a TP53 Y220C Mutation
A Phase 1 study testing GenSci128 tablets in people with Solid Tumors Harboring a TP53 Y220C Mutation, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GenSci128 Tablet in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors Harboring a TP53 Y220C Mutation
- What is being tested?
- GenSci128 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2025to Oct 2028
- Phase
- Phase 1
- 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
- Has the ability to understand and the willingness to sign a written informed consent document (prior to the initiation dose of GenSci128 and any study procedures)
- Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures
- Has confirmed TP53 Y220C mutation in tumor tissue
- Has histologically or cytologically confirmed locally advanced or metastatic solid tumors and have progressed following standard therapy, or for whom, in the opinion of the investigator, no available and effective standard therapy exists.
- Has at least one measurable lesion by RECIST v1.1
- Has an ECOG status of 0 or 1
- Has a life expectancy of ≥ 3 months.
Who cannot join
- Has diagnosed as primary central nervous system (CNS) tumor.
- Has CNS metastases, unless asymptomatic, neurologically stable and not requiring steroids treatment for at least 2 weeks prior to initiation dose of GenSci128.
- Has a history of leptomeningeal disease or spinal cord compression.
- Has stroke or transient ischemic attack within 6 months prior to initiation dose of GenSci128.
- Has active infection requiring intravenous (IV) antibiotics or other uncontrolled inter-current illness requiring hospitalization. Minor infections, e.g., periodontal infection or urinary tract infection (UTI), which may be treated with short term oral antibiotics are allowed.
- Uncontrolled hypertension (Blood pressure ≥ 150/90 mmHg despite optimal medical management)
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- Has a history of prior organ transplant or allogeneic stem cell transplant.
- Has received a selective reactivator of p53 Y220C mutation.
- Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤ 14 days after intervention).
- Has known human immunodeficiency virus (HIV) infection (positive HIV 1/2 antibodies) or known chronic hepatitis B or C [participants positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA; participants positive for hepatitis C virus (HCV) IgG will be eligible if they are negative for HCV-RNA].
- Is persisting toxicity related to prior anticancer therapy (NCI CTCAE V5.0 Grade>1). However, alopecia and sensory neuropathy Grade ≤2, or other Grade ≤2 adverse events not constituting a safety risk, based on the investigator's judgment are acceptable.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or GenSci128 administration or may interfere with the interpretation of study results, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital ,Fudan University
Shanghai, Shanghai Municipality, 200032
Tianshu Liu, Doctor, +8613681973996
liu.tianshu@zs-hospital.sh.cn
About this study
Official title: A Phase I, Multicenter, Multinational, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GenSci128 Tablet in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation
The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GenSci128 Tablet in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation
- Being tested
- GenSci128 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci128 tabletsDrug
GenSci128 tablets have three specifications, including 50mg, 200mg, 500mg, and are taken in combination with the doctor's advice in different dose levels. GenSci128 will be orally administrated daily (except single dose in Cycle 0) with no interruptions until occurrence of unacceptable toxicity, or progressive disease, or withdrawal of consent, or death, or contact lost, or starting a new anticancer therapy, etc. (whichever occurs first).
| Study group | Role | What they receive |
|---|---|---|
| 150mg dose level | Experimental | Not described Receives: Drug: GenSci128 tablets |
| 300mg dose level | Experimental | Not described Receives: Drug: GenSci128 tablets |
| 600mg dose level | Experimental | Not described Receives: Drug: GenSci128 tablets |
| 1200mg dose level | Experimental | Not described Receives: Drug: GenSci128 tablets |
| 1800mg dose level | Experimental | Not described Receives: Drug: GenSci128 tablets |
| 2500mg dose level | Experimental | Not described Receives: Drug: GenSci128 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) and dose limiting toxicities (DLTs)
Part 1 is a dose escalation study ，to assess the safety and tolerability of GenSci128 in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation
Measured: 3 weeks
maximal tolerance dose （MTD）、recommended dose of expansion （RDE）
Part 1 is a dose escalation study ，to determine the maximum tolerated dose (MTD), if any, and recommend dose of expansion (RDE) for GenSci128 in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation
Measured: up to 3 months
recommended phase 2 dose （RP2D）
Part 2 is a dose expansion study，Determining Recommended Phase II Dose
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start10 Jun 2025
- Primary completionDec 2027 (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 Solid Tumors Harboring a TP53 Y220C MutationStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908434
- Sponsor's protocol ID
- GenSci128-101
- Status last verified
- Dec 2025
- First submitted
- 19 Mar 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Multinational, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GenSci128 Tablet in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation
- ClinicalTrials.gov ID
- NCT06908434
- Acronym / sponsor ID
- GenSci128-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 3 Apr 2025 (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.
The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GenSci128 Tablet in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 150mg dose level | Experimental | Drug: GenSci128 tablets |
| 300mg dose level | Experimental | Drug: GenSci128 tablets |
| 600mg dose level | Experimental | Drug: GenSci128 tablets |
| 1200mg dose level | Experimental | Drug: GenSci128 tablets |
| 1800mg dose level | Experimental | Drug: GenSci128 tablets |
| 2500mg dose level | Experimental | Drug: GenSci128 tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has the ability to understand and the willingness to sign a written informed consent document (prior to the initiation dose of GenSci128 and any study procedures)
- Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures
- Has confirmed TP53 Y220C mutation in tumor tissue
- Has histologically or cytologically confirmed locally advanced or metastatic solid tumors and have progressed following standard therapy, or for whom, in the opinion of the investigator, no available and effective standard therapy exists.
- Has at least one measurable lesion by RECIST v1.1
Key exclusion criteria (12 listed)
- Has diagnosed as primary central nervous system (CNS) tumor.
- Has CNS metastases, unless asymptomatic, neurologically stable and not requiring steroids treatment for at least 2 weeks prior to initiation dose of GenSci128.
- Has a history of leptomeningeal disease or spinal cord compression.
- Has stroke or transient ischemic attack within 6 months prior to initiation dose of GenSci128.
- Has active infection requiring intravenous (IV) antibiotics or other uncontrolled inter-current illness requiring hospitalization. Minor infections, e.g., periodontal infection or urinary tract infection (UTI), which may be treated with short term oral antibiotics are allowed.
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 |
|---|---|---|
| GenSci128 tabletsGenSci128 tablets have three specifications, including 50mg, 200mg, 500mg, and are taken in combination with the doctor's advice in different dose levels. GenSci128 will be orally administrated daily (except single dose in Cycle 0) with no interruptions until occurrence of unacceptable toxicity, or progressive disease, or withdrawal of consent, or death, or contact lost, or starting a new anticancer therapy, etc. (whichever occurs first). | Drug | 1200mg dose level, 150mg dose level, 1800mg dose level, 2500mg dose level, 300mg dose level, 600mg dose level |
Primary outcome
Incidence and severity of adverse events (AEs) and dose limiting toxicities (DLTs)
Time frame: 3 weeks
Part 1 is a dose escalation study ，to assess the safety and tolerability of GenSci128 in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation
maximal tolerance dose （MTD）、recommended dose of expansion （RDE）
Time frame: up to 3 months
Part 1 is a dose escalation study ，to determine the maximum tolerated dose (MTD), if any, and recommend dose of expansion (RDE) for GenSci128 in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation
recommended phase 2 dose （RP2D）
Time frame: up to 3 months
Part 2 is a dose expansion study，Determining Recommended Phase II Dose
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 30 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GenSci128 tablets in people with Solid Tumors Harboring a TP53 Y220C Mutation, run by Changchun GeneScience 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 12 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 30 Dec 2025. 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?
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 Wen Xu (+8618861095711, xuwen01@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) and dose limiting toxicities (DLTs) (time frame: 3 weeks). The study lists 3 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 30 Dec 2025.