Actively Recruiting
Study of Safety, Tolerability, and Preliminary Anti-Tumor Activity of Oral GenSci122 in Advanced Solid Tumors
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2025-01-22
163
Participants Needed
9
Research Sites
320 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a first-in-human, multicenter, open-label Phase I study to evaluate the safety, tolerability, pharmacokinetics, and early effectiveness of GenSci122 in adults with advanced solid tumors. The study aims to assess this investigational oral KIF18A inhibitor in participants who have recurrent or metastatic tumors that have not responded to standard treatments or for whom no standard therapy exists. The study has two parts: dose escalation and dose expansion, each with distinct goals related to safety and anti-tumor activity. Participants will receive GenSci122 tablets orally once daily, with doses of either 50 mg or 250 mg depending on the study phase. The dose escalation part focuses on determining safe dosage levels by monitoring dose-limiting toxicities over two years. The dose expansion part will evaluate the objective tumor response rate over a three-year period. Participants must provide tumor tissue samples and undergo various assessments throughout the study. During the study, participants will be closely monitored through physical exams, laboratory tests, and imaging to assess tumor response and safety. Researchers will evaluate side effects, drug levels in the body, and tumor changes using standardized criteria. Participants' survival and overall health status will also be followed, with a minimum expected survival of 12 weeks. The study includes detailed eligibility assessments and requires participants to comply with contraceptive measures if applicable, as well as safety monitoring for up to three years.
CONDITIONS
Official Title
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy With GenSci122 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent and sign the informed consent form.
- Male or female participants aged 18 years or older at the time of consent.
- Have recurrent or metastatic advanced solid tumors that have failed or are intolerant to standard treatment, or have no standard therapy.
- Agree to provide fresh or archived tumor tissue and corresponding pathological report.
- Have an expected survival of at least 12 weeks.
- Have Eastern Cooperative Oncology Group performance status of 0 to 1.
- Have at least one measurable target lesion.
- Have adequate organ function without recent blood transfusion or use of hematopoietic stimulating factors within 14 days before the first dose.
- All toxicity from prior cancer therapies resolved to grade 1 or less.
- Congestive heart failure of grade 1 severity or less and fully resolved.
- Normal QT interval on screening ECG.
- If HIV positive, stable on antiretroviral therapy for at least 4 weeks before first dose, viral load under 400 copies/mL, and CD4+ T-cell count of 350 cells/µL or higher.
- Negative hepatitis B and C tests; if active hepatitis B, viral DNA must be below specified thresholds and antiviral therapy must be received; if hepatitis C positive, must be on antiviral therapy with liver function grade 1 or less.
- Women of childbearing potential must have a negative pregnancy test within 7 days before first dose and agree to use two effective contraceptive methods during and for 6 months after the study.
- Men with partners of childbearing potential must use barrier contraception or abstinence during the study and for 3 months after discontinuation.
You will not qualify if you...
- Use of investigational agent or anticancer therapy within 5 half-lives or 4 weeks before first dose.
- Major surgery (excluding vascular access placement) within 4 weeks before first dose.
- Radiotherapy within 4 weeks before first dose or not recovered to baseline from radiotherapy effects.
- Symptomatic primary central nervous system tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
- Significant active cardiovascular disease or myocardial infarction within 6 months before first dose.
- Active uncontrolled infection or serious ongoing illness despite treatment.
- Inability to swallow pills or active malabsorption syndrome affecting drug absorption.
- Pregnancy or breastfeeding.
- History of previous cancer except certain skin cancers or in situ carcinomas with at least 3 years remission.
- Significant liver disease, including viral hepatitis or current alcohol abuse.
- Allergy to GenSci122 or its components.
- Serious illness or psychiatric condition that may affect safety or study compliance.
- Prior treatment with KIF18A inhibitor.
- Presence of DNA polymerase epsilon gene hotspot mutation or hypermutator phenotype.
- Other conditions judged by investigator to make participant ineligible.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
3
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
4
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, China, 45000
Not Yet Recruiting
5
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Not Yet Recruiting
6
Jiang Su Province Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
7
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Not Yet Recruiting
8
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
9
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
Research Team
X
Xi Deng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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