Actively Recruiting
A Study of CSCJC3456 in Patients With Advanced Malignant Tumors
Led by Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd. · Updated on 2026-02-02
102
Participants Needed
2
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, open phase I clinical study of dose escalation, cohort expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CSCJC3456 in patients with advanced malignant solid tumors.
CONDITIONS
Official Title
A Study of CSCJC3456 in Patients With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and follow study requirements
- Aged 18 to 75 years, male or female
- Expected survival of at least 12 weeks
- ECOG performance status score of 0 or 1
- Phase Ia: Advanced malignant solid tumors confirmed by pathology or cytology with disease progression despite standard treatment, intolerance to standard treatment, or no effective standard treatment, and at least one measurable lesion per RECIST v1.1
- Phase Ib: Confirmed histology or cytology of hepatocellular carcinoma, colorectal cancer, gastric cancer, recurrent/metastatic endometrial cancer, or other sensitive tumor types identified in Phase Ia; failed or intolerant to standard treatment; at least one measurable lesion per RECIST v1.1
- Recovered from toxic effects of previous treatment to CTCAE grade 1 or less (except hair loss and pigmentation)
- Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg, stable antihypertensive medication for 7 days prior to first dose
- Adequate organ and bone marrow function
- Female participants of childbearing age must have negative serum pregnancy test within 7 days before starting medication and agree to effective contraception during study and for 3 months after last dose
- Male participants with female partners of childbearing age must agree to effective contraception during study and for 3 months after last dose
- Breastfeeding women must agree to cease breastfeeding during study and for 3 months after last dose
- Have gene sequencing results of current tumor or be willing to provide tumor tissue specimens
You will not qualify if you...
- Previous or current diagnosis of other malignancies except for cured basal cell carcinoma of skin, superficial bladder cancer, squamous cell carcinoma of skin, cervical carcinoma in situ, or breast cancer in situ
- Second primary cancer cured with no recurrence within 5 years
- Allergy to any component of the study drug or history of severe allergies
- Major surgery or trauma within 4 weeks before first study drug, except diagnostic biopsies
- Use of traditional Chinese patent medicines with anti-tumor effects within 2 weeks before first study drug
- Anti-neoplastic therapies within 4 weeks or 5 half-lives of investigational drug before first dose, whichever is shorter
- Use of potent CYP2C8 or CYP3A4 inducers or inhibitors within specified time frames before first dose
- Use of medications known to prolong QT interval within 1 week or 5 half-lives before first dose
- Prior treatment with FGFR inhibitors
- History of central nervous system metastasis or spinal cord compression unless clinically stable and meeting timing criteria for prior treatments
- Advanced patients with symptoms, viscera spread, or at risk of life-threatening complications requiring recent paracentesis or with unstable effusions
- Cardiovascular disease within 6 months prior to screening
- Uncontrolled systemic diseases such as diabetes or hypertension
- Current pulmonary diseases like sudden pulmonary disease, interstitial lung disease, pneumonia, or pulmonary fibrosis except local radiation-induced interstitial pneumonia
- History or risk of gastrointestinal bleeding or previous grade 3 or higher gastrointestinal perforation or fistula
- Grade 3 or higher diarrhea during screening
- Evidence of active infection
- Positive for HIV RNA or treponema pallidum antibodies
- Conditions severely affecting oral medication absorption
- History of neurological or psychiatric disorders including epilepsy or dementia
- Receipt of investigational drug within 4 weeks before first administration or concurrent participation in another clinical study not observational or follow-up
- Deemed unsuitable for the study by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
Research Team
N
Ning Li, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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