| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Solid Tumor Lymphoma | Drug: Manganese Chloride Drug: Anti-PD-1 antibody Combination Product: Systemic therapy | Phase 1 |
| 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 |
| 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:
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:
Combination Product: Systemic therapy Whether and which should be given depends on the treatment regimen before enrollment.
|
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Weidong Han, M.D. | +861066937463 | hanwdrsw@sina.com |
| 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 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 14, 2019 | ||||
| First Posted Date ICMJE | June 19, 2019 | ||||
| Last Update Posted Date | August 28, 2019 | ||||
| Actual Study Start Date ICMJE | November 1, 2018 | ||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Safety Study of the Pan-immunotherapy in Patients With Unresectable/Metastatic Solid Tumors or Lymphomas | ||||
| Official Title ICMJE | 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 | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
20 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | May 31, 2020 | ||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03991559 | ||||
| Other Study ID Numbers ICMJE | CHN-PLAGH-BT-039 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Han weidong, Chinese PLA General Hospital | ||||
| Study Sponsor ICMJE | Chinese PLA General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Chinese PLA General Hospital | ||||
| Verification Date | August 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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