Status:
UNKNOWN
An Open-label, Phase I/II Study of Manganese Plus Radiotherapy in Patients With Metastatic Solid Tumors or Lymphoma
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Solid Tumor
Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- Subjects must have histologically proven metastatic solid tumors or lymphoma.
- Subjects must have at least two distinct measurable sites of disease (≥1 cm).
- ≥ 18 years old.
- Life expectancy of at least 6 months.
- Eastern Cooperative Oncology Group performance status 0-2.
- Subjects must have stable or progressing disease to the ongoing systemic therapy.
- Multiple lines of previous chemo-immunotherapy were permitted.
- Patients with known brain metastases were included in the trial but brain lesions were not eligible as target or non-target lesions.
- Adequate organ function.
- 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.
- 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
- 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.
- 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.
- Subjects with previous or concurrent other malignancies.
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04873440
Start Date
May 6 2021
End Date
May 31 2023
Last Update
May 5 2021
Active Locations (1)
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1
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853