Efficacy and Safety of 3D185 Monotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Cholangiocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D185.
- Who it may be relevant to
- Registry conditions: Cholangiocarcinoma,Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Single Arm, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of 3D185 Monotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Alterations
Overview
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
- Drug 3D185
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.
Primary outcome measures
- ORR [Time frame: 24 months]
Secondary outcome measures (6)
- Duration of response (DoR) [Time frame: 24 months]
- Disease control rate (DCR) [Time frame: 24 months]
- Progression-free survival (PFS) [Time frame: 24 months]
- Overall survival (OS) [Time frame: 24 months]
- 3D185 Plasma concentration [Time frame: 24 months]
- Serum phosphate levels [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Histologically or cytologically confirmed cholangiocarcinoma.
- Documented disease progression following at least one previous systemic cancer therapy
- Tumor assessment for FGF/FGFR gene alteration status.
- Have measurable disease according to RECIST v1.1
- ECOG Performance Status ≤ 2
- Life expectancy ≥ 12 weeks.
Exclusion criteria
- Previously received selective FGFR inhibitor therapy.
- 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.
- 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..
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05039892 · 3D185-C-002