HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04965220
• Other study ID #: HLX208-MEK-001
• Status: Recruiting
• Phase: Phase 1
• Start date: January 5, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Shanghai Henlius Biotech
• Contact: Zhang Li, leading PI
• Email: zhangli[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18Y=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;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• HLX 208
take orally

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD	maximum tolerated dose	from first dose to the end of Cycle 1 (each cycle is 21 days)
Secondary	RP2D	Recommended dose for phase II clinical trials	from first dose to the end of Cycle 1 (each cycle is 21 days)
Secondary	Peak Plasma Concentration (Cmax) of HLX208	pharmacokinetics	from first dose to the beginning of Cycle 4 (each cycle is 21 days)
Secondary	ORR	The number of patients with CR or PR divided by the total number of treated patients whose disease was measurable at baseline	from first dose to the last patient was followed up for 6 month
Secondary	Area under the plasma concentration versus time curve (AUC)of HLX208	pharmacokinetics	from first dose to the beginning of Cycle 4 (each cycle is 21 days)