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

Phase 1

Recruiting

• Conditions: Solid Tumor
• Interventions: Drug: HLX 208

• Registration Number: NCT04965220
• Lead Sponsor: Shanghai Henlius Biotech

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-16
• Study Start: 2022-01-05
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09
• Primary Completion: 2024-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary brain tumor	HLX 208	HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)
other solid tumor	HLX 208	HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)
CRC(KRAS mutant)	HLX 208	HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)
ATC	HLX 208	HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)

Primary Outcome Measures

Name	Time	Method
MTD	from first dose to the end of Cycle 1 (each cycle is 21 days)	maximum tolerated dose

Secondary Outcome Measures

Name	Time	Method
RP2D	from first dose to the end of Cycle 1 (each cycle is 21 days)	Recommended dose for phase II clinical trials
Peak Plasma Concentration (Cmax) of HLX208	from first dose to the beginning of Cycle 4 (each cycle is 21 days)	pharmacokinetics
ORR	from first dose to the last patient was followed up for 6 month	The number of patients with CR or PR divided by the total number of treated patients whose disease was measurable at baseline
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)	pharmacokinetics

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, China