Solid TumorPhase 1NCT03991559
A Safety Study of the Pan-immunotherapy in Patients With Unresectable/Metastatic Solid Tumors or Lymphomas
A Phase 1 study testing Manganese Chloride, Anti-PD-1 antibody and Systemic therapy in people with Solid Tumor and Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor, Lymphoma
- What is being tested?
- Manganese Chloride, Anti-PD-1 antibody and Systemic therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 31 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have histologically proven unresectable/ metastatic solid tumors or lymphomas.
- ≥ 18 years old.
- Life expectancy of at least 6 months.
- Eastern Cooperative Oncology Group performance status 0-2.
- Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
- Subjects must have received at least two frontline therapies, except for patients initially diagnosed with local advanced or metastatic pancreatic cancer or cholangiocarcinoma.
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- 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.
- Adequate organ function.
- 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.
Who cannot join
- Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- T cell lymphomas or leukemia.
- Prior organ allograft.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Weidong Han, M.D, +86-10-66937463, hanwdrsw@sina.com
Qingming Yang, M.D, +86-10-55499341, yangqm301@163.com
About this study
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
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.
- Conditions
- Solid Tumor, Lymphoma
- Being tested
- Manganese Chloride, Anti-PD-1 antibody, Systemic therapy
- Keywords
- anti-PD-1 antibody, Manganese, unresectable, metastatic
- Medical subject headings
- Lymphoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manganese ChlorideDrug
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
Anti-PD-1 antibodyDrug
Also called Anti-PD-1 monoclonal antibody, PD-1 inhibitor
Administered intravenously, at 2-4mg/kg on day 3 in a 3-week cycle
Systemic therapyCombination product
Whether and which should be given depends on the treatment regimen before enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Dose-Escalation, intranasally | Active comparator | 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. Receives: Drug: Manganese Chloride; Drug: Anti-PD-1 antibody; Combination Product: Systemic therapy |
| Dose-Escalation, inhalation | Active comparator | 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. Receives: Drug: Manganese Chloride; Drug: Anti-PD-1 antibody; Combination Product: Systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with treatment-related adverse events (AEs)
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.
Measured: Approximately 6 months
Number of subjects with specific Manganese-related adverse events
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.
Measured: Approximately 6 months
Secondary outcomes (3)
Preliminary efficacy evaluation
Objective response rate (ORR) and disease control rate (DCR) will be evaluated by investigators per the RECIST V1.1.
Measured: Approximately 6 months
The q3w pharmacokinetic profile of Manganese
PK parameters such as Maximum concentration (Cmax) are assessed.
Measured: Approximately 3 months
Number of participants with laboratory test abnormalities
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.
Measured: Approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Nov 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991559
- Sponsor's protocol ID
- CHN-PLAGH-BT-039
- Status last verified
- Aug 2019
- First submitted
- 14 Jun 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03991559
- Acronym / sponsor ID
- CHN-PLAGH-BT-039
- Conditions
- Solid Tumor, Lymphoma
- Keywords
- anti-PD-1 antibody, Manganese, unresectable, metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose-Escalation, intranasally | Active comparator | Drug: Manganese Chloride, Drug: Anti-PD-1 antibody, Combination Product: Systemic therapyWith 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. |
| Dose-Escalation, inhalation | Active comparator | Drug: Manganese Chloride, Drug: Anti-PD-1 antibody, Combination Product: Systemic therapyWith 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must have histologically proven unresectable/ metastatic solid tumors or lymphomas.
- ≥ 18 years old.
- Life expectancy of at least 6 months.
- Eastern Cooperative Oncology Group performance status 0-2.
- Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
Key exclusion criteria (7 listed)
- Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- T cell lymphomas or leukemia.
- Prior organ allograft.
- Women who are pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manganese ChlorideAdministered 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 | Dose-Escalation, inhalation, Dose-Escalation, intranasally |
| Anti-PD-1 antibodyAlso: Anti-PD-1 monoclonal antibody, PD-1 inhibitorAdministered intravenously, at 2-4mg/kg on day 3 in a 3-week cycle | Drug | Dose-Escalation, inhalation, Dose-Escalation, intranasally |
| Systemic therapyWhether and which should be given depends on the treatment regimen before enrollment. | Combination product | Dose-Escalation, inhalation, Dose-Escalation, intranasally |
Primary outcome
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.
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.
3 secondary outcomes
Preliminary efficacy evaluation
Time frame: Approximately 6 months
The q3w pharmacokinetic profile of Manganese
Time frame: Approximately 3 months
Number of participants with laboratory test abnormalities
Time frame: Approximately 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Manganese Chloride, Anti-PD-1 antibody and Systemic therapy in people with Solid Tumor and Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weidong Han, M.D. (+861066937463, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with treatment-related adverse events (AEs) (time frame: Approximately 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.