Actively Recruiting
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy With GenSci122 in Participants With 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
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.
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
CONTACT
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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