NCT04965220

Brief Summary

A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumors

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 5, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

June 9, 2021

Last Update Submit

August 7, 2023

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • MTD

    maximum tolerated dose

    from first dose to the end of Cycle 1 (each cycle is 21 days)

Secondary Outcomes (4)

  • RP2D

    from first dose to the end of Cycle 1 (each cycle is 21 days)

  • Peak Plasma Concentration (Cmax) of HLX208

    from first dose to the beginning of Cycle 4 (each cycle is 21 days)

  • ORR

    from first dose to the last patient was followed up for 6 month

  • Area under the plasma concentration versus time curve (AUC)of HLX208

    from first dose to the beginning of Cycle 4 (each cycle is 21 days)

Study Arms (4)

ATC

EXPERIMENTAL

HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)

Drug: HLX 208

Primary brain tumor

EXPERIMENTAL

HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)

Drug: HLX 208

CRC(KRAS mutant)

EXPERIMENTAL

HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)

Drug: HLX 208

other solid tumor

EXPERIMENTAL

HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)

Drug: HLX 208

Interventions

HLX 208DRUG

take orally

Also known as: trametinib
ATCCRC(KRAS mutant)Primary brain tumorother solid tumor

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Y≤Age≤75Y
  • Good Organ Function
  • Expected survival time ≥ 3 months
  • Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment
  • Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
  • ECOG score 0-1;
  • Expected survival time of more than 3 months;

You may not qualify if:

  • Previous treatment with BRAF inhibitors or MEK inhibitors
  • Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
  • Current or former patients with interstitial lung disease;
  • Active clinical severe infection;
  • A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
  • Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, 510060, China

RECRUITING

MeSH Terms

Interventions

trametinib

Central Study Contacts

Zhang Li, leading PI

CONTACT

zhangli@sysucc.org.cn

Guo ye, PI

CONTACT

pattrickguo@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

July 16, 2021

Study Start

January 5, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2025

Last Updated

August 9, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

CN(1)