The Efficacy and Safety of HLX208 in Advanced Anaplastic... | NCT05102292

Studies
The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation

NCT05102292

Sponsor

Shanghai Henlius Biotech

Status

Unknown status

Last Update Posted

Aug 21, 2023Actual

Enrollment

25Estimated

Phase

Phase 1Phase 2

Conditions

Anaplastic Thyroid Cancer
ATC

Interventions

HLX208

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2021Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Oct 20, 2021

First Submission Date that Met QC Criteria

Oct 20, 2021

First Posted Date

Nov 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2023

Last Update Posted Date

Aug 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study was to assess efficacy, safety and PK in anaplastic thyroid cancer (ATC) given HLX208 (BRAF V600E inhibitor).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HLX208	Experimental	Participants receive HLX208 450mg bid po	Drug: HLX208

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HLX208	Drug	HLX208 450mg bid po	HLX208	BRAF V600E inhibitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ORR	Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)	up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
PFS	Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )	from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
OS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age>=18Y;
Good Organ Function;
Expected survival time ≥ 3 months;
Advanced BRAF V600 ATC that have been diagnosed histologically;
At least one measurable lesion as per RECIST v1.1;
ECOG score 0-1.

Exclusion Criteria:

Pregnant or lactating women;
Previous treatment with BRAF inhibitors or MEK inhibitors;
A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin;
Severe active infections requiring systemic anti-infective therapy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Affiliated Oncology Hospital		Shanghai			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065646	Thyroid Carcinoma, Anaplastic

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000726503	CCT239065

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided