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

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 3D Medicines (Beijing) Co., Ltd.

Criteria

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.