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NCT Number: NCT05039892

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

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.

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Key information

Conditions

Cholangiocarcinoma,Adult Adenocarcinoma Carcinoma Cholangiocarcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D185

Drug

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 outcomes

  1. ORR

    Time frame: 24 months

    defined as the proportion of subjects who achieved a confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by investigators.

Secondary outcomes

  1. Duration of response (DoR)

    Time frame: 24 months

    DoR is defined as the time from the date of first CR or PR based on RECIST v1.1 to the date of first documented progressive disease based on RECIST v1.1 or death, whichever occurs first.

  2. Disease control rate (DCR)

    Time frame: 24 months

    defined as the proportion of subjects who achieve a confirmed complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST v1.1 as assessed by investigators.

  3. Progression-free survival (PFS)

    Time frame: 24 months

    PFS is defined as the time from the date of first study dose to disease progression based on RECIST v1.1 or death, whichever occurs first.

  4. Overall survival (OS)

    Time frame: 24 months

    OS is defined as the date of first study dose to the date of death from any cause.

  5. 3D185 Plasma concentration

    Time frame: 24 months

    The pharmacokinetic and pharmacodynamics assessments will be analyzed descriptively and presented in appropriate tables or figures.

  6. Serum phosphate levels

    Time frame: 24 months

    The pharmacokinetic and pharmacodynamics assessments will be analyzed descriptively and presented in appropriate tables or figures.

Study contacts

Contact information is provided by the study sponsor or research team.

silong xiang, MD

CONTACT

[email protected]

( 86)15901312398

Sponsors and collaborators

Lead sponsor

3D Medicines (Beijing) Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 10, 2021
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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