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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04198818
Recruitment Status : Not yet recruiting
First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
ShangHai HaiHe Pharmaceutical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Tumors Melanoma Non-Small-Cell Lung Cancer Erdheim-Chester Disease Other RAS/RAF/MEK/ERK Mutated Tumors Drug: HH2710 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 22, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : March 31, 2022


Arm Intervention/treatment
Experimental: Dose escalaltion study of HH2710
to determin the MTD of HH2710 and/or Recommended Phase II dose (RP2D).
Drug: HH2710
25mg; 50mg; 100mg; 200mg; 300mg; 400mg; 500mgBID(Decided by SMC accroding to the safty and PK data)




Primary Outcome Measures :
  1. MTD(Max tolerance does) [ Time Frame: 21 Days ]
    To evaluate the MTD in patients with advanced solid tumor



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • main 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.
  • 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:

Main 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

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): NCT04198818


Contacts
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Contact: Harb Wael Abou, M.D. 765-446-5111 Wharb@horizonbioadvance.com

Sponsors and Collaborators
ShangHai HaiHe Pharmaceutical

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Responsible Party: ShangHai HaiHe Pharmaceutical
ClinicalTrials.gov Identifier: NCT04198818    
Other Study ID Numbers: HH2710-G101
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ShangHai HaiHe Pharmaceutical:
Melanoma
Non-Small-Cell Lung Cancer
Erdheim-Chester Disease
MAPK pathway
ERK1
ERK2
Additional relevant MeSH terms:
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Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Carcinoma, Non-Small-Cell Lung
Melanoma
Erdheim-Chester Disease
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Nevi and Melanomas
Histiocytosis, Non-Langerhans-Cell
Histiocytosis
Lymphatic Diseases