Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Antibodies

Cisplatin

Immunomodulating Agents

Immunoglobulins

Manganese

Immune Checkpoint Inhibitors

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Trace Elements

Subject received Manganese primed Sintilimab, nab-paclitaxel and platinum chemotherapy every 3 weeks until achieving a second assessable complete response or progressive disease, development of unacceptable toxicity, or withdrawal of consent.

Subject received Sintilimab, nab-paclitaxel and platinum chemotherapy every 3 weeks until achieving a second assessable complete response or progressive disease, development of unacceptable toxicity, or withdrawal of consent.

Administered by inhalation at 0.4mg/kg twice per week in the first 3-week cycle, and then inhaled 0.4mg/kg twice in the first week of each 3-week cycle thereafter

Manganese Chloride

Administered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming)

nab-paclitaxel

Administered intravenously, Cisplatin (60-80mg/m2) or Carboplatin (area under the curve \[AUC\] 4-6 mg/mL per min) on day 2 in a 3-week cycle (day 1 without Manganese priming)

Platinum chemotherapy

Administered intravenously, 200mg on day 3 in a 3-week cycle (day 2 without Manganese priming)

Sintilimab

Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer death in women. Platinum chemotherapy has been widely adopted as a standard treatment for advanced ovarian cancer, the response rates in patients with relapsed/refractory ovarian cancer is unacceptably low. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This two-arm, phase I/II study is designed to assess the safety and efficacy of combined therapy of anti-PD-1 antibody and chemotherapy with or without Manganese priming.

An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Relapsed/Refractory Ovarian Cancer

A Phase I/II, Open-label, Two-arm, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Relapsed/Refractory Ovarian Cancer

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

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.

Chinese PLA General Hospital

Professor

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

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

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.

Principal Investigator

Antibodies, Monoclonal

Immunoglobulins, Intravenous

Immunologic Factors

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.

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.

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

Administered intravenously, at 2-4mg/kg on day 3 in a 3-week cycle

Anti-PD-1 antibody

Whether and which should be given depends on the treatment regimen before enrollment.

Systemic therapy

Weidong Han, M.D

Qingming Yang, M.D

Qian Mei, M.D

Meixia Chen, M.S

Yan Zhang, M.S

Kaichao Feng, M.S

Yang Liu, M.D.

Jiejie Liu, B.S

Xiang Li, B.S

Liang Dong, B.S

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.

A Safety Study of the Pan-immunotherapy in Patients With Unresectable/Metastatic Solid Tumors or Lymphomas

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

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.

Objective response rate (ORR) and disease control rate (DCR) will be evaluated by investigators per the RECIST V1.1.

PK parameters such as Maximum concentration (Cmax) are assessed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Relapsed/Refractory Ovarian Cancer	NCT03989336	Ovarian Cancer	Manganese Chlor... nab-paclitaxel Platinum chemot... Sintilimab	18 Years - 70 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
A Safety Study of the Pan-immunotherapy in Patients With Unresectable/Metastatic Solid Tumors or Lymphomas	NCT03991559	Solid Tumor Lymphoma	Manganese Chlor... Anti-PD-1 antib... Systemic therap...	18 Years - 80 Years	Chinese PLA General Hospital
An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Relapsed/Refractory Ovarian Cancer	NCT03989336	Ovarian Cancer	Manganese Chlor... nab-paclitaxel Platinum chemot... Sintilimab	18 Years - 70 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
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 manganese

Every month we try and update this database with for manganese cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for manganese

Every month we try and update this database with for manganese cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for manganese cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.