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NCT05039892Not yet recruitingPhase 2

Efficacy and Safety of 3D185 Monotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Cholangiocarcinoma

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

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
50 (estimated)
First submitted
2 Sept 2021
Start date
1 Dec 2026
Primary completion date
31 Dec 2027
Lead sponsor
3D Medicines (Beijing) Co., Ltd.
NCT number
NCT05039892

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 50
  • From 1 Dec 2026 to the primary completion date, 31 Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously received selective FGFR inhibitor therapy.
  • 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.

Other illness

  • 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.

Age

  • 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..

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.