Cholangiocarcinoma,Adult
Conditions
Brief summary
The purpose of this study is evaluate the efficacy of 3D185 in subjects with advanced/metastatic cholangiocarcinoma with FGFR2 Gene Alterations who have failed at least 1 previous treatment.
Interventions
DRUG3D185
All eligible subjects will receive the RP2D regimen to be established based on the results of the ongoing phase I study from Cycle 1 Day 1 (C1D1) until disease progression, intolerable toxicity, withdrawal of consent, whichever occurs first.
Sponsors
3D Medicines (Beijing) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed cholangiocarcinoma. 2. Documented disease progression following at least one previous systemic cancer therapy 3. Tumor assessment for FGF/FGFR gene alteration status. 4. Have measurable disease according to RECIST v1.1 5. ECOG Performance Status ≤ 2 6. Life expectancy ≥ 12 weeks.
Exclusion criteria
1. Previously received selective FGFR inhibitor therapy. 2. History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications. 3. Have any of the following eye diseases/conditions: 1) history of retinal pigment epithelial detachment (RPED); 2) history of laser treatment or intraocular injection for macular degeneration; 3) history of dry or wet age-related macular degeneration; 4) history of retinal vein occlusion (RVO); 5) history of retinal degenerative diseases; 6) history of chorioretinal lesions.. 4. Received CYP3A4 and/or CYP2C8 strong inhibitors or CYP3A4 strong inducers within 14 days prior to the first dose and subject who need to continue using these drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 24 months | defined as the proportion of subjects who achieved a confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by investigators. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DoR) | 24 months | DoR is defined as the time from the date of first CR or PR based on RECIST v1.1 to the date of first documented progressive disease based on RECIST v1.1 or death, whichever occurs first. |
| Disease control rate (DCR) | 24 months | defined as the proportion of subjects who achieve a confirmed complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST v1.1 as assessed by investigators. |
| Progression-free survival (PFS) | 24 months | PFS is defined as the time from the date of first study dose to disease progression based on RECIST v1.1 or death, whichever occurs first. |
| Overall survival (OS) | 24 months | OS is defined as the date of first study dose to the date of death from any cause. |
| 3D185 Plasma concentration | 24 months | The pharmacokinetic and pharmacodynamics assessments will be analyzed descriptively and presented in appropriate tables or figures. |
| Serum phosphate levels | 24 months | The pharmacokinetic and pharmacodynamics assessments will be analyzed descriptively and presented in appropriate tables or figures. |
Contacts
CONTACTsilong xiang, MD
Outcome results
None listed