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Advanced Solid TumorPhase 1NCT06772415

A Study to Investigate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy With GenSci122 in Participants With Advanced Solid Tumors

A Phase 1 study testing GenSci122 tablet 50mg and GenSci122 tablet 250mg in people with Advanced Solid Tumor, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 9 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a first-in-human (FIH), multicenter, open-label, phase I study to evaluate the safety, tolerability, PK and preliminary efficacy of GenSci122 in participants with advanced solid tumors. The study consists of 2 parts: Part 1- dose-escalation and Part 2- dose expansion. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
GenSci122 tablet 50mg and GenSci122 tablet 250mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
9 sitesChina
Study dates
8 Jan 2025to Mar 2031
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide informed consent and sign the informed consent form (ICF).
  • Male or female participants ≥18 years old at the time of consent.
  • Meeting the requirements of tumor types shown below:
  • Dose escalation:
  • Participants with a histological or cytological diagnosis of recurrent or metastatic advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.
  • Dose expansion:
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  • Participants with a histological or cytological diagnosis of recurrent or metastatic advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.
  • Participants agree to provide fresh or archived tumor tissue as well as corresponding pathological report.
  • Survival expectations are ≥ 12 weeks.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 (Appendix 1).
  • At least one measurable target lesion
  • Participants with adequate organ function at the time of screening (requiring no blood transfusion, no use of hematopoietic stimulating factor or human albumin or use of drug for correction within 14 days before the first dose)
  • All toxicity related to prior cancer therapies must have resolved to ≤ Grade 1
  • Congestive heart failure (CHF), which must have been ≤ Grade 1 in severity at the time of occurrence and must have resolved completely.
  • Normal QT interval on screening ECG evaluation
  • Participants with a known HIV infection are eligible if the following criteria are met:
  • Stable on antiretroviral therapy for ≥ 4 weeks before the first dose of GenSci122.
  • Viral load of < 400 copies per mL at screening. e. CD4+ T-cell count ≥ 350 cells/μL at screening.
  • Hepatitis B virus (HBV) and hepatitis C virus (HCV) test is negative. If participants have active HBV infection: HBV- deoxyribonucleic acid (DNA) must be < 500 IU/mL (or must be < 2500 copy/mL if copy/mL is the only unit available in the study site) and are willing to receive antiviral therapy throughout the study (treatment in accordance with local standard of care, e.g., entecavir); participants with positive HCV ribonucleic acid (RNA) must receive antiviral therapy in accordance with the local standard treatment guideline and have ≤ CTCAE 5.0 Grade 1 elevated hepatic function.
  • Women of childbearing potential (WOCBP) must have a serum pregnancy test negative within 7 days before the first dose of GenSci122. WOCBP must agree to avoid pregnancy during the study and agree to the use 2 effective contraceptive methods (hormonal or barrier method of birth control, or abstinence) before study entry, for the duration of study participation, and in the following 6 months after discontinuation of Gensci122
  • Men with a partner(s) of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 3 months after discontinuation of GenSci122 and to use appropriate barrier contraception or abstinence

Who cannot join

  • Investigational agent or anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) before the first dose of GenSci122. In addition, no concurrent investigational anti-cancer therapy is permitted.
  • Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of GenSci122.
  • Radiotherapy within 4 weeks before the first dose of GenSci122. Or participants have not yet recovered from acute effects of radiotherapy to baseline before the first dose of GenSci122.
  • Symptomatic primary central nervous system (CNS) tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months before the first dose of GenSci122.
  • Active uncontrolled systemic bacterial, viral, or fungal infection, or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. Screening for chronic conditions is not required.
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  • Inability to swallow pills or clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of GenSci122.
  • Pregnancy or lactation.
  • History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma, for which by the date of the first dose of GenSci122, at least 3 years of complete remission and no other treatment is needed or expected during the study period.
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse
  • Allergic to GenSci122 tablet or its components.
  • Any serious illness, uncontrolled inter-current illness, psychiatric illness, or other medical history, including lab results, which in the opinion of investigator or medical monitor would be likely to impact safety or compliance with study requirements or confounds the ability to interpret the data.
  • Has a treatment history of KIF18A inhibitor.
  • Participants with DNA polymerase epsilon (POLE) gene hotspot mutated, or hypermutator phenotype.
  • Other conditions that are not eligible for inclusion based on the investigator's judgment.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xi Deng contact

+86 18616809834

dengxi@genscigroup.com

9 sites in 1 country

China9 sites, 9 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100000

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Not yet recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Not yet recruiting

  • Jiang Su Province Hospital

    Nanjing, Jiangsu, 210029

    Not yet recruiting

  • ZhongShan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

    Not yet recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Not yet recruiting

  • The first affiliated hospital of Zhengzhou university

    Zhengzhou, Henan, 45000

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase I Study of Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral KIF18A Inhibitor GenSci122 in Participants With Advanced Solid Tumors

This is a first-in-human (FIH), multicenter, open-label, phase I study to evaluate the safety, tolerability, PK and preliminary efficacy of GenSci122 in participants with advanced solid tumors. The study consists of 2 parts: Part 1- dose-escalation and Part 2- dose expansion. The primary endpoint of Dose escalation is To assess the safety and tolerability of GenSci122. The primary endpoint of Dose expansion is to evaluate the preliminary anti-tumor activity of GenSci122 in participants with advanced solid tumors.

Being tested
GenSci122 tablet 50mg, GenSci122 tablet 250mg

What participants receive

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

  • GenSci122 tablet 50mgDrug

    Orally Once Daily

  • GenSci122 tablet 250mgDrug

    Orally Once Daily

Study groups in NCT06772415
Study groupRoleWhat they receive
Single armExperimentalNot described
Receives: Drug: GenSci122 tablet 50mg; Drug: GenSci122 tablet 250mg

What is being measured

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

  1. Dose escalation: Incidence of dose-limiting toxicities (DLTs).

    Measured: 2 years

  2. Dose expansion: Objective response rate (ORR) evaluated by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).

    Measured: 3 Years

Secondary outcomes (7)

  1. Incidence and severity of TEAEs.

    Measured: 3 years

  2. Maximum Plasma Concentration (Cmax) of Gensci122

    Measured: 3 years

  3. Time to Maximum Plasma Concentration (Tmax) of Gensci122

    Measured: 3 years

  4. Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for Gensci122

    Measured: 3 years

  5. Duration of Response (DOR)

    Measured: 3 years

  6. Progression-free Survival (PFS)

    Measured: 3 years

  7. Overall Survival (OS)

    Measured: 3 years

Timeline

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

  1. First posted13 Jan 2025
  2. Study start8 Jan 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionMar 2031 (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
Model description
Part 1 Does escalation, Part 2 Dose expansion
Masking
None (open label)
Enrolment
163 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06772415
Sponsor's protocol ID
GenSci122-101
Status last verified
Jan 2025
First submitted
2 Jan 2025
Last updated
22 Jan 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GenSci122 tablet 50mg and GenSci122 tablet 250mg in people with Advanced Solid Tumor, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 9 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 21 inclusion and 15 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 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 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 Xi Deng (+86 18616809834, dengxi@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose escalation: Incidence of dose-limiting toxicities (DLTs). (time frame: 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?

On the ClinicalTrials.gov record for NCT06772415.

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 22 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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