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

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Henlius Biotech
• Treatments: Trametinib

Criteria

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.