ADC Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of HER-2 Positive Advanced Solid Tumors(PRaG3.0)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-04-30

Brief Summary

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This is an open-label, single-arm, Phase II investigator-initiated trial of antibody-drug conjugate combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory solid tumors with HER-2 positive

Detailed Description

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Conditions

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Carcinoma Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

Group Type EXPERIMENTAL

ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

Intervention Type DRUG

RC48-ADC combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2

Interventions

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ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

RC48-ADC combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Aged 18 years and above;
2. Diagnosed with histologically or cytologically-confirmed, HER2-positive(IHC 1+, 2+ or 3+), standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy;
3. ECOG(Eastern Cooperative Oncology Group) performance is 0-3;
4. Life expectancy greater than 3 months;
5. T lymphocyte absolute value ≥0.5 upper limit of normal (ULN), absolute neutrophil count(ANC)≥1.0 x 10(9)/L；serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3.0\*ULN, or AST and ALT≤5\*ULN with hepatic metastasis; Total serum creatinine ≤1.5\*ULN；
6. Signed informed consent form；

Exclusion Criteria

1. Current pregnancy or lactation；
2. History of other malignant tumors within 5 years prior to dose administration, expect for：malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer);
3. Uncontrolled epilepsy, central nervous system diseases or mental illness;
4. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study;
5. Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
6. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes;
7. Allergic to any of the ingredients used in the study;
8. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or other immune-related disease requiring long-term oral hormone therapy;
9. Acute and chronic tuberculosis infection;
10. Other disorders with clinical significance according to the researcher's judgment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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ADC Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of HER-2 Positive Advanced Solid Tumors(PRaG3.0)

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

Interventions

ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Second Affiliated Hospital of Soochow University

Responsible Party

Locations

The First Bethune Hospital of Jilin University

The First People's Hospital of Changzhou

Harbin Medical University Cancer Hospital

Jiangyin Peoples Hospital

Qilu Hospital of Shangdong University

Shandong Cancer Hospital

The First People's Hospital of Kunshan

Jiangsu Cancer Hospital

Jiangsu Province Hospital of Chinese Medicine

Jiangsu Province Hospital

Nanjing Drum Tower Hospital

Affiliated Hospital of Nantong University

The First Hospital of China Medical University

Second Affiliated Hospital of Soochow University

Suzhou Municipal Hospital

The First Affiliated Hospital of Soochow University

Weihai Municipal Hospital

Affiliated Hospital of Jiangnan University

The Affiliated Hospital of Xuzhou Medical University

Countries

Central Contacts

Liyuan Zhang, doctor

Facility Contacts

Xin Jiang

Wendong Gu

Lili Yu

Jian Wang

Bingxu Tan

Dali Han

Minbin Chen

Li Yin

Dahai Yu

Yuandong Cao

Jing Yan

Xiancheng Liu

Qiao Qiao

Liyuan zhang

Jundong Zhou

songbing Qin

Fujun Yang

Ke Gu

Jianshe Wang

Other Identifiers

JD-LK-2021-121-01