Back to results

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

Primary Purpose

Cholangiocarcinoma,Adult

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

3D185

About this trial

This is an interventional treatment trial for Cholangiocarcinoma,Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All eligible subjects

Arm Description

Outcomes

Primary Outcome Measures

ORR

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 Outcome Measures

Duration of response (DoR)

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.

Disease control rate (DCR)

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.

Progression-free survival (PFS)

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.

Overall survival (OS)

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

3D185 Plasma concentration

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

Serum phosphate levels

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

Full Information

NCT ID

NCT05039892

First Posted

September 2, 2021

Last Updated

October 11, 2023

Sponsor

3D Medicines (Beijing) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05039892

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2024 (Anticipated)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

3D Medicines (Beijing) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocarcinoma,Adult

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

All eligible subjects

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

3D185

Intervention Description

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 Outcome Measure Information:

Title

ORR

Description

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.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Duration of response (DoR)

Description

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.

Time Frame

24 months

Title

Disease control rate (DCR)

Description

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.

Time Frame

24 months

Title

Progression-free survival (PFS)

Description

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.

Time Frame

24 months

Title

Overall survival (OS)

Description

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

Time Frame

24 months

Title

3D185 Plasma concentration

Description

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

Time Frame

24 months

Title

Serum phosphate levels

Description

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

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

silong xiang, MD

Phone

( 86)15901312398

silong.xiang@3d-medicines.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs