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A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patient With Advanced Tumors

NCT04198818

Description:

This is a First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patients with Advanced Tumors, composed of a Phase I dose escalation and dose expansion stage and a Phase II dose extension stage.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patient With Advanced Tumors
  • Official Title: A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patients With Advanced Tumors

Clinical Trial IDs

  • ORG STUDY ID: HH2710-G101
  • NCT ID: NCT04198818

Conditions

  • Advanced Tumors
  • Melanoma
  • Non-Small-Cell Lung Cancer
  • Erdheim-Chester Disease
  • Other RAS/RAF/MEK/ERK Mutated Tumors

Interventions

DrugSynonymsArms
HH2710Dose escalaltion study of HH2710

Purpose

This is a First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patients with Advanced Tumors, composed of a Phase I dose escalation and dose expansion stage and a Phase II dose extension stage.

Detailed Description

      HH2710 is developed by Shanghai Haihe Pharmaceutical Co., Ltd. HH2710 is a highly potent,
      selective, reversible, ATP-competitive ERK1/2 inhibitor. This is a first-in-human study of
      HH2710 and is designed as an open-label, multicenter, Phase I/II study which is composed of a
      Phase I dose escalation and dose expansion stage and a Phase II dose extension stage.
    

Trial Arms

NameTypeDescriptionInterventions
Dose escalaltion study of HH2710Experimentalto determin the MTD of HH2710 and/or Recommended Phase II dose (RP2D).
  • HH2710

Eligibility Criteria

        Inclusion Criteria:

          1. Provide signed and dated informed consent prior to initiation of any study-related
             procedures.

          2. Male or female patients aged ≥ 18 years.

          3. Phase I dose escalation stage: Patients who have been diagnosed with histologically or
             cytological documented, unresectable/metastatic tumors that are refractory or
             intolerant to standard therapy or for whom no curative standard therapy exists.

          4. For LCH/ECD: Eligible patients must have multifocal disease and the diagnosis must be
             confirmed by pathological evaluation of the affected tissue.

          5. Patients in the Phase I dose escalation portion of the trial may have measurable (per
             RECIST v1.1) or evaluable disease. Patients in the Phase I dose expansion and Phase II
             portions of the trial must have measurable disease per RECIST v1.1.

          6. Eastern Cooperative Oncology Group (ECOG) performance status≤1.

          7. Predicted life expectancy ≥ 3 months;

          8. Willing and able to participate in the trial and comply with all trial requirements;

        Exclusion Criteria:

          1. Gastrointestinal condition which could impair absorption of study medication;

          2. Patients who have previously participated in clinical trials of ERK inhibitors drug;

          3. Any use of an investigational drug within 28 days or 5 half-lives (whichever is
             shorter) prior to the first dose of HH2710
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:MTD(Max tolerance does)
Time Frame:21 Days
Safety Issue:
Description:To evaluate the MTD in patients with advanced solid tumor

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:ShangHai HaiHe Pharmaceutical

Trial Keywords

  • Melanoma
  • Non-Small-Cell Lung Cancer
  • Erdheim-Chester Disease
  • MAPK pathway
  • ERK1
  • ERK2

Last Updated

March 10, 2020