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Trial record 17 of 34 for:    Han weidong

A Safety Study of the Pan-immunotherapy in Patients With Unresectable/Metastatic Solid Tumors or Lymphomas

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ClinicalTrials.gov Identifier: NCT03991559
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Brief Summary:
Identification of T cell inhibitory signals, including PD-1/PD-L1, has prompted the development of a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. However, elimination of cancer by T cells is only one step in the Cancer-Immunity Cycle, which enable providing several therapeutic targets and tailoring of combinations of immune therapies. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This study is a first-in-man, Phase I, 3 + 3 dose escalation study of a combined regimen of Manganese and anti-PD-1 antibody with or without chemotherapies in subjects with unresectable/ metastatic solid tumors or lymphomas. This study is designed to assess the safety, tolerability, pharmacokinetic profile (PK profile), mode of delivery and Recommended Phase 2 Dose (RP2D) of this regimen.

Condition or disease Intervention/treatment Phase
Solid Tumor Lymphoma Drug: Manganese Chloride Drug: Anti-PD-1 antibody Combination Product: Systemic therapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Two-arm, Open-label, Single-center, Dose-escalation Study to Evaluate the Safety, Tolerability and Recommended Dose and Delivery Mode of the Pan-immunotherapy in Subjects With Unresectable/ Metastatic Solid Tumors or Lymphomas
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Active Comparator: Dose-Escalation, intranasally
With a standard 3+3 dose escalation design, the enrollment will proceed until the maximum tolerated dose (MTD) has been defined or the highest dose level has been reached.
Drug: Manganese Chloride
Administered intranasally in Arm 1 (0.05, 0.1 or 0.2 mg/kg/d) and by inhalation in Arm 2 (0.1, 0.2 or 0.4mg/kg/d) once daily in a 3-week cycle

Drug: Anti-PD-1 antibody
Administered intravenously, at 2-4mg/kg on day 3 in a 3-week cycle
Other Names:
  • Anti-PD-1 monoclonal antibody
  • PD-1 inhibitor

Combination Product: Systemic therapy
Whether and which should be given depends on the treatment regimen before enrollment.

Active Comparator: Dose-Escalation, inhalation
With a standard 3+3 dose escalation design, the enrollment will proceed until the MTD has been defined or the highest dose level has been reached.
Drug: Manganese Chloride
Administered intranasally in Arm 1 (0.05, 0.1 or 0.2 mg/kg/d) and by inhalation in Arm 2 (0.1, 0.2 or 0.4mg/kg/d) once daily in a 3-week cycle

Drug: Anti-PD-1 antibody
Administered intravenously, at 2-4mg/kg on day 3 in a 3-week cycle
Other Names:
  • Anti-PD-1 monoclonal antibody
  • PD-1 inhibitor

Combination Product: Systemic therapy
Whether and which should be given depends on the treatment regimen before enrollment.




Primary Outcome Measures :
  1. Number of Subjects with treatment-related adverse events (AEs) [ Time Frame: Approximately 6 months ]
    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.

  2. Number of subjects with specific Manganese-related adverse events [ Time Frame: Approximately 6 months ]
    Manganese-related AEs were considered to be that start or worsen after administration Manganese administration,improve after withdrawal, and even occur again after re-administration.


Secondary Outcome Measures :
  1. Preliminary efficacy evaluation [ Time Frame: Approximately 6 months ]
    Objective response rate (ORR) and disease control rate (DCR) will be evaluated by investigators per the RECIST V1.1.

  2. The q3w pharmacokinetic profile of Manganese [ Time Frame: Approximately 3 months ]
    PK parameters such as Maximum concentration (Cmax) are assessed.

  3. Number of participants with laboratory test abnormalities [ Time Frame: Approximately 3 months ]
    The laboratory tests of serum cytokines and chemokines will be performed on day 1 and 3 of each cycle, and the abnormality will be determined by the investigator.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have histologically proven unresectable/ metastatic solid tumors or lymphomas.
  2. ≥ 18 years old.
  3. Life expectancy of at least 6 months.
  4. Eastern Cooperative Oncology Group performance status 0-2.
  5. Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
  6. Subjects must have received at least two frontline therapies, except for patients initially diagnosed with local advanced or metastatic pancreatic cancer or cholangiocarcinoma.
  7. Subjects must be off prior therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. Subjects with Anti-PD-1 antibody are eligible which must be resistance.
  8. Adequate organ function.
  9. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.

Exclusion Criteria:

  1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
  2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
  3. T cell lymphomas or leukemia.
  4. Prior organ allograft.
  5. Women who are pregnant or breastfeeding.
  6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
  7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

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): NCT03991559


Contacts
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Contact: Weidong Han, M.D. +861066937463 hanwdrsw@sina.com

Locations
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China, Beijing
Biotherapeutic Department of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Weidong Han, M.D    +86-10-66937463    hanwdrsw@sina.com   
Contact: Qingming Yang, M.D    +86-10-55499341    yangqm301@163.com   
Principal Investigator: Weidong Han, M.D         
Principal Investigator: Qian Mei, M.D         
Principal Investigator: Qingming Yang, M.D         
Principal Investigator: Meixia Chen, M.S         
Principal Investigator: Yan Zhang, M.S         
Principal Investigator: Kaichao Feng, M.S         
Sub-Investigator: Yang Liu, M.D.         
Sub-Investigator: Jiejie Liu, B.S         
Sub-Investigator: Xiang Li, B.S         
Sub-Investigator: Liang Dong, B.S         
Sponsors and Collaborators
Chinese PLA General Hospital

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Responsible Party: Han weidong, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03991559     History of Changes
Other Study ID Numbers: CHN-PLAGH-BT-039
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han weidong, Chinese PLA General Hospital:
anti-PD-1 antibody
Manganese
unresectable
metastatic
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Manganese
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Trace Elements
Micronutrients
Nutrients
Growth Substances