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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2024

Interventions

  • Drug: HLX 208
    • take orally

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • RP2D
    • Time Frame: 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
    • Time Frame: from first dose to the beginning of Cycle 4 (each cycle is 21 days)
    • pharmacokinetics
  • ORR
    • Time Frame: 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
    • Time Frame: from first dose to the beginning of Cycle 4 (each cycle is 21 days)
    • pharmacokinetics

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Henlius Biotech
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Zhang Li, leading PI, zhangli@sysucc.org.cn

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