Clinical trial NCT04873440: An Open-label, Phase I/II Study of Manganese Plus Radiotherapy in Patients With Metastatic Solid Tumors or Lymphoma
Official title: A Phase I/II, Open-label Study to Evaluate the Abscopal Response and Safety of Manganese and Standard-of-care Radiotherapy/ SBRT in Subjects With Metastatic Solid Tumors or Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Lymphoma
Keywords: metastatic
radiotherapy
manganese
abscopal response
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Radiotherapy is a regular care for metastatic solid tumors or lymphoma, and it can induce immunogenic death of tumor cells and a stronger immune response. Sometimes, tumor regression would be observed at sites distant to an irradiated field because of the radiotherapy-induced anticancer immune responses, so-called abscopal response. Manganese has been confirmed to activate innate immune and function as anticancer immunoadjuvant in pre-clinical studies. This study is designed to assess the abscopal response and safety of combined therapy of manganese and radiotherapy in patients with metastatic solid tumors or lymphoma.


Eligibility criteria: Inclusion Criteria:

1. Subjects must have histologically proven metastatic solid tumors or lymphoma.
2. Subjects must have at least two distinct measurable sites of disease (≥1 cm).
3. ≥ 18 years old.
4. Life expectancy of at least 6 months.
5. Eastern Cooperative Oncology Group performance status 0-2.
6. Subjects must have stable or progressing disease to the ongoing systemic therapy.
7. Multiple lines of previous chemo-immunotherapy were permitted.
8. Patients with known brain metastases were included in the trial but brain lesions were not eligible as target or non-target lesions.
9. Adequate organ function.
10. Female 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.
11. Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug 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. Prior organ allograft.
4. Women who are pregnant or breastfeeding.
5. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
6. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
7. Subjects with previous or concurrent other malignancies.

Primary outcomes:
measure: Proportion of subjects with an abscopal response
timeFrame: 6 months
measure: Number of subjects with treatment-related adverse events (AEs)
timeFrame: 12 months
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: 12 months
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
measure: Number of participants with laboratory test abnormalities
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Biotherapeutic Department of Chinese PLA General Hospital
state: Beijing
Study officials:
References: