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

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ClinicalTrials.gov Identifier: NCT04965220
Recruitment Status : Not yet recruiting
First Posted : July 16, 2021
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
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 trimetinib in patients with advanced solid tumors

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: HLX 208 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : September 15, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Trametinib

Arm Intervention/treatment
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)
Drug: HLX 208
take orally
Other Name: trametinib

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)
Drug: HLX 208
take orally
Other Name: trametinib

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)
Drug: HLX 208
take orally
Other Name: trametinib

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)
Drug: HLX 208
take orally
Other Name: trametinib




Primary Outcome Measures :
  1. MTD [ Time Frame: from first dose to the end of Cycle 1 (each cycle is 21 days) ]
    maximum tolerated dose


Secondary Outcome Measures :
  1. RP2D [ Time Frame: from first dose to the end of Cycle 1 (each cycle is 21 days) ]
    Recommended dose for phase II clinical trials

  2. Peak Plasma Concentration (Cmax) of HLX208 [ Time Frame: from first dose to the beginning of Cycle 4 (each cycle is 21 days) ]
    pharmacokinetics

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04965220


Contacts
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Contact: Zhang Li, leading PI 13902282893 zhangli@sysucc.org.cn
Contact: Guo ye, PI pattrickguo@gmail.com

Sponsors and Collaborators
Shanghai Henlius Biotech
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Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT04965220    
Other Study ID Numbers: HLX208-MEK-001
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Trametinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action