Not Yet RecruitingPhase 2

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

50 participantsStarted 2026-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

ORR

Timeframe: 24 months

Trial details

NCT IDNCT05039892

Sponsor3D Medicines (Beijing) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

silong xiang, MD

( 86)15901312398 silong.xiang@3d-medicines.com

View on ClinicalTrials.gov More Cholangiocarcinoma,Adult trials