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

3D Medicines

Status and phase: Begins enrollment in 9 months; Phase 2

Conditions: Cholangiocarcinoma,Adult

Treatments: Drug: 3D185

Study type: Interventional

Funder types: Industry

Identifiers

NCT05039892

3D185-C-002

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

All eligible subjects

Experimental group

Treatment:

Drug: 3D185