A Monotherapy in Subjects With Advanced Solid Tumors
- Conditions
- Solid Tumor, Adult
- Registration Number
- NCT04221204
- Lead Sponsor
- 3D Medicines (Beijing) Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Study Population:<br><br>In the study, male or female adult subjects = 18 years of age, with advanced solid tumors<br>with no prior standard therapy or failed to establish standard therapies are eligible.<br><br>Inclusion Criteria:<br><br> 1. Subjects must be male or female and = 18 years of age on the day of enrollment.<br><br> 2. Subjects must have a histological diagnosis of locally advanced or metastatic<br> malignant solid tumors. Subjects must have failed or have been intolerant to<br> established standard therapies, or standard therapies did not exist or were no<br> longer effective for a given tumor type, or in the opinion of the Investigator have<br> been considered ineligible for a particular form of standard therapy on medical<br> grounds.<br><br> 3. Subjects must have at least one evaluable lesion (according to RECIST 1.1, see<br> Appendix 1);<br><br> 4. ECOG Performance Status of 0 or 1.<br><br> 5. Life expectancy = 12 weeks.<br><br> 6. Subjects must have normal levels of total serum calcium and total phosphate.<br><br> 7. Subjects must have adequate organ and bone marrow function (no hematopoietic growth<br> factor, blood transfusion, or platelet therapy within 1 week before the first dose):<br><br> - CBC: neutrophils = 1.5 × 109/L, platelets = 100 × 109/L, hemoglobin = 9.0 g/dL.<br><br> - Liver function: total bilirubin = 1.5 × ULN; ALT/AST = 2.5 × ULN without liver<br> metastasis; ALT/AST = 5 × ULN with liver metastasis;<br><br> - Coagulation: International normalized ratio (INR) = 1.5 × ULN and activated<br> partial thromboplastin time (APTT) = 1.5 × ULN (for patients undergoing<br> anticoagulant therapy. The Investigator will judge that the INR and APTT are<br> within a safe and effective treatment range).<br><br> - Renal function: serum creatinine = 1.5 × ULN, or creatinine clearance = 60<br> mL/min/1.73 m2 in the condition of creatinine level > ULN; urine protein<br> qualitative = 1 + (if = 2+, 24 hours of urine protein test is required, if 24<br> hours urine protein <1 g, then allowed to enroll);<br><br> - Adequate cardiac function left ventricular ejection fraction (LVEF) > 50% for 2<br> dimensional cardiac ultrasound;<br><br> 8. Subjects must have signed and dated an IRB/IEC approved written informed consent<br> form that under regulatory and institutional guidelines, and this must be obtained<br> before the performance of any protocol-related procedures.<br><br>Exclusion Criteria:<br><br>Subjects who meet any of the following criteria should be excluded from the study:<br><br> 1. Subjects who received other investigational products or devices in other clinical<br> trials within 4 weeks before the first dose;<br><br> 2. Subjects who received anti-tumor therapy (except for mitomycin, nitrosourea, and<br> fluorouracil oral drugs) within 4 weeks before the first dose, including but not<br> limited to chemotherapy, radiotherapy (palliative radiotherapy is completed at least<br> 2 weeks before the first dose can enroll), targeted therapy or immunotherapy.<br><br> Note: Mitomycin and nitrosourea have been treated within 6 weeks after the last<br> dose; oral fluorouracil such as tegafur and capecitabine has been treated within 2<br> weeks after the last dose.<br><br> 3. Subjects who previously received FGFR1-3 specific inhibitor therapy.<br><br> 4. Subjects who have previous toxicity of anti-tumor therapy that has not been returned<br> to level 0 or 1. (Alopecia, chemotherapy-induced peripheral neurotoxicity and<br> ototoxicity = Grade 2 can enroll);<br><br> 5. Subjects who received a CYP3A4 and/or CYP2C8 strong inhibitor or a CYP3A4 strong<br> inducer (see Appendix 6) within 7 days prior to the first dose, and need to continue<br> using these drugs;<br><br> 6. Subjects who have any of the following eye diseases/conditions:<br><br> - History of retinal pigment epithelial detachment (RPED);<br><br> - History of laser treatment or intraocular injection for macular degeneration;<br><br> - History of dry or wet age-related macular degeneration;<br><br> - History of retinal vein occlusion (RVO);<br><br> - History of retinal degenerative diseases;<br><br> - History of chorioretinal lesions;<br><br> 7. Subjects who received clinical intervention for biliary obstruction 14 days prior to<br> the first dose or the Investigator judges that the symptoms had not resolved or<br> required anti-infective treatment.<br><br> 8. Subjects who have gastrointestinal disorders that will affect oral administration or<br> the Investigator judges that the absorption of 3D185 will be interfered.<br><br> 9. Subjects underwent major surgery (except biopsy), or the surgical incision has not<br> completely healed within 4 weeks prior to the first dose.<br><br> 10. Subjects who had clinically uncontrollable pleural effusion, ascites, or pericardial<br> effusion within 2 weeks prior to the first dose.<br><br> 11. Subjects who have symptomatic brain metastases or spinal cord compression. Subjects<br> who have previously treatment for brain metastases, if the clinical condition is<br> stable and imaging evidence does not show disease progression within 4 weeks prior<br> to the first dose, and do not need corticosteroid treatment within 2 weeks prior to<br> the first dose, can enroll.<br><br> 12. Subjects who have active bacterial or fungal infections (CTCAE = 2) that required<br> systemic treatment within 14 days prior to the first dose.<br><br> 13. Subjects who have active HBV infection (Tests should include assessment of HBsAg and<br> HBc IgG antibody. If one parameter is positive, determine HBV-DNA to confirm acute<br> infection. Patients with positive results for HBsAg and/or HBV-DNA are considered<br> active HBV infection) and/or active HCV infection (HCV antibody testing positive);<br><br> 14. Subjects who have clinically significant cardiovascular diseases that occurred 6<br> months prior to enrollment. Cardiovascular diseases include, but not limited to<br> follows:<br><br> - Acute myocardial infarction;<br><br> - Severe/unstable angina;<br><br> - Cerebrovascular accident or transient ischemic attack;<br><br> - Congestive heart failure (New York Heart Association > Class II, see Appendix<br> 3);<br><br> - Arrhythmias that require antiarrhythmic treatment except for beta blockers or<br> digoxin;<br><br> - Repeated ECG with QTc interval > 450 ms;<br><br> - High blood pressure that cannot be controlled by antihypertensive drugs<br> (systolic blood pressure > 150 mm Hg, diastolic blood pressure > 100 mmHg).<br><br> 15. Subjects who have clinically significant abnormal serum electrolytes (Patients must<br> have corrected calcium and phosphate < institutional ULN).<br><br> 16. Subjects who are receiving warfarin (low-dose warfarin as 2 mg/day is acceptable);<br> or receiving antiplatelet anticoagulant therapy (aspirin at dose =300 mg/day,<br> clopidogrel at dose =75 mg/day).<br><br> 17. Female subjects in pregnancy or lactation. Male subjects or female subjects at<br> reproductive ages who are unwilling to receive effective contraceptive measures.<br><br> 18. Subjects who are judged by the Investigator to be unsuitable for this study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Evaluation: frequency and severity of AEs;Tolerability Evaluation: frequency and severity of AEs
- Secondary Outcome Measures
Name Time Method Efficacy evaluation: Complete Response;Pharmacokinetics (PK) evaluation: Cmax (mg/L);PK evaluation: Tmax (minutes);PK evaluation: AUC0-24 h, AUC0-96 h, AUC0-8,;PK evaluation: t1/2;PK evaluation: Clearance;PK evaluation: Vd.;Progressive Disease evaluation;Efficacy evaluation: Partial Response;Efficacy evaluation: Stable Disease;Efficacy evaluation: Disease Progression;Objective Response Rale (ORR) (CR+PR);disease control rate (DCR) (CR+PR+SD)