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 Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2
|
Drug: 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
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate （ORR） [24 months]
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
Secondary Outcome Measures
- Progression-free Survival (PFS) [24 months]
PFS was defined as the time from the first administration of study treatment to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever comes first.
- Disease control rate (DCR) [24 months]
DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD)
- Overall survival (OS) [24 months]
OS was defined as the time from the first administration of study treatment to death from any cause.
- Adverse event [24 months]
rate of adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 18 years and above;
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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;
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ECOG(Eastern Cooperative Oncology Group) performance is 0-3;
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Life expectancy greater than 3 months;
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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) ≤3.0ULN, or AST and ALT≤5ULN with hepatic metastasis; Total serum creatinine ≤1.5*ULN；
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Signed informed consent form；
Exclusion Criteria:
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Current pregnancy or lactation；
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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);
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Uncontrolled epilepsy, central nervous system diseases or mental illness;
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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;
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Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
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Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes;
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Allergic to any of the ingredients used in the study;
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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;
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Acute and chronic tuberculosis infection;
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Other disorders with clinical significance according to the researcher's judgment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Bethune Hospital of Jilin University | Changchun | China | ||
| 2 | The First People's Hospital of Changzhou | Changzhou | China | ||
| 3 | Harbin Medical University Cancer Hospital | Harbin | China | ||
| 4 | Jiangyin Peoples Hospital | Jiangyin | China | ||
| 5 | Qilu Hospital of Shangdong University | Jinan | China | ||
| 6 | Shandong Cancer Hospital | Jinan | China | ||
| 7 | The First People's Hospital of Kunshan | Kunshan | China | ||
| 8 | Jiangsu Cancer Hospital | Nanjing | China | ||
| 9 | Jiangsu Province Hospital of Chinese Medicine | Nanjing | China | ||
| 10 | Jiangsu Province Hospital | Nanjing | China | ||
| 11 | Nanjing Drum Tower Hospital | Nanjing | China | ||
| 12 | Affiliated Hospital of Nantong University | Nantong | China | ||
| 13 | The First Hospital of China Medical University | Shenyang | China | ||
| 14 | Second Affiliated Hospital of Soochow University | Suzhou | China | ||
| 15 | Suzhou Municipal Hospital | Suzhou | China | ||
| 16 | The First Affiliated Hospital of Soochow University | Suzhou | China | ||
| 17 | Weihai Municipal Hospital | Weihai | China | ||
| 18 | Affiliated Hospital of Jiangnan University | Wuxi | China | ||
| 19 | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | China |
Sponsors and Collaborators
- Second Affiliated Hospital of Soochow University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JD-LK-2021-121-01