An Open-label, Phase I/II Study of Manganese Plus Radiotherapy in Patients With Metastatic Solid Tumors or Lymphoma

NCT04873440 | Unknown Phase 1 DMC

• 1 other identifier: CHN-PLAGH-BT-063
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor; Lymphoma

Keywords

metastatic; radiotherapy; manganese; abscopal response

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects with an abscopal response

  An abscopal response was defi ned as a decrease in the longest diameter of at least 30% in any measurable (≥1 cm) non-irradiated lesion from baseline.

  6 months

• 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.

  12 months

Secondary Outcomes (4)

• Disease control rate (DCR)

  12 months

• Progression-free survival (PFS)

  24 months

• Overall survival (OS)

  24 months

• Number of participants with laboratory test abnormalities

  12 months

Study Arms (1)

Manganese plus Radiotherapy

EXPERIMENTAL

Subject received standard-of-care radiotherapy or stereotactic body radiation therapy (SBRT) to one metastatic site. Manganese inhalation began 1 week after the start of radiotherapy and lasted up to 6 months. The same systemic therapy before the enrollment will be maintained.

Drug: Manganese Chloride; Radiation: Radiotherapy; Drug: Chemo-immunotherapy

Interventions

Manganese Chloride DRUG

Administered by inhalation at 0.4mg/kg/d twice a week

Also known as: Mn2+

Manganese plus Radiotherapy

Radiotherapy RADIATION

Measurable lesions were targeted for radiotherapy at the discretion of the treating physician.Standard-of-care radiotherapy or SBRT were both allowed.

Manganese plus Radiotherapy

Chemo-immunotherapy DRUG

The same chemotherapy and/or anti-PD-1 therapy before thei patients' enrolment were allowed. Whether and which should be given depends on the treatment regimen before enrollment.

Manganese plus Radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Lymphoma; Neoplasm Metastasis

Interventions

manganese chloride; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Weidong Han, M.D.

CONTACT

+861066937463; hanwdrsw69@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: May 6, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2023
• Last Updated: May 5, 2021

Record last verified: 2021-05

Locations

CN (1)