Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Camurati-Engelmann Disease

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).

Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).

Fresolimumab

Radiation Therapy

Silvia Formenti, M.D.

The purpose of this study is to test safety of combining fresolimumab and local radiotherapy and to see if the combination can achieve tumor regression.

Fresolimumab and Radiotherapy in Metastatic Breast Cancer

Defined as the percentage of patients who have responses (complete or partial) outside the irradiated lesions. The abscopal response is assessed at 15 weeks, and confirmed minimum 4 weeks later. The abscopal response is evaluated based on immune-related response criteria (irRC) (Wolchok et al, 2009).

University of California, Los Angeles

Weill Medical College of Cornell University

Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).

Fresolimumab

Radiation Therapy

Arm 1 (Fresolimumab 1 mg/kg)

Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).

Fresolimumab

Radiation Therapy

Arm 2 (Fresolimumab 10 mg/kg)

Total

Age, Categorical

Sex: Female, Male

Asian or Pacific Islander

Black, not of Hispanic-American Origin

White, not of Hispanic-American origin

Other/Unknown

Race/Ethnicity, Customized

Nelly Huppert

Abscopal Response Rate

Overall Study

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Micronutrients

Immunomodulating Agents

Manganese

Trace Elements

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.

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

Manganese Chloride

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

Radiotherapy

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.

Chemo-immunotherapy

Weidong Han, M.D.

Weidong D Han, M.D.

Weidong Han

Qian Mei

Yang Liu

Qingming Yang

Yan Zhang

Meixia Chen

Zhipeng Guo

Jiejie Liu

Miaomiao Bai

Fengxia Shi

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.

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

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

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.

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.

DCR is defined as the proportion of subjects who achieved a stable disease (SD), partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

PFS time was measured from study entry to the first documentation of disease progression or death. Disease progression was determined per the RECIST V1.1.

OS time was measured from the study entry to the date of death.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fresolimumab and Radiotherapy in Metastatic Breast Cancer	NCT01401062	Metastatic Brea...	Fresolimumab Radiation Thera...	18 Years -	Weill Medical College of Cornell University
An Open-label, Phase I/II Study of Manganese Plus Radiotherapy in Patients With Metastatic Solid Tumors or Lymphoma	NCT04873440	Solid Tumor Lymphoma	Manganese Chlor... Radiotherapy Chemo-immunothe...	18 Years - 80 Years	Chinese PLA General Hospital
Fresolimumab and Radiotherapy in Metastatic Breast Cancer	NCT01401062	Metastatic Brea...	Fresolimumab Radiation Thera...	18 Years -	Weill Medical College of Cornell University
An Open-label, Phase I/II Study of Manganese Plus Radiotherapy in Patients With Metastatic Solid Tumors or Lymphoma	NCT04873440	Solid Tumor Lymphoma	Manganese Chlor... Radiotherapy Chemo-immunothe...	18 Years - 80 Years	Chinese PLA General Hospital
An Open-label, Phase I/II Study of Manganese Plus Radiotherapy in Patients With Metastatic Solid Tumors or Lymphoma	NCT04873440	Solid Tumor Lymphoma	Manganese Chlor... Radiotherapy Chemo-immunothe...	18 Years - 80 Years	Chinese PLA General Hospital

Spots Global Cancer Trial Database for abscopal response