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)
Antibody-Drug Conjugate Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment Advanced Refractory Solid Tumors With HER-2 Positive(PRaG3.0)
1 other identifier
interventional
55
1 country
19
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2021
Typical duration for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedNovember 10, 2021
November 1, 2021
3 years
November 4, 2021
November 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate （ORR）
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
24 months
Secondary Outcomes (4)
Progression-free Survival (PFS)
24 months
Disease control rate (DCR)
24 months
Overall survival (OS)
24 months
Adverse event
24 months
Study Arms (1)
ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2
EXPERIMENTALInterventions
RC48-ADC combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2
Eligibility Criteria
You may qualify if:
- Aged 18 years and above;
- 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;
- ECOG(Eastern Cooperative Oncology Group) performance is 0-3;
- Life expectancy greater than 3 months;
- 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；
- Signed informed consent form；
You may not qualify if:
- Current pregnancy or lactation；
- 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);
- Uncontrolled epilepsy, central nervous system diseases or mental illness;
- 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;
- Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes;
- Allergic to any of the ingredients used in the study;
- 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;
- Acute and chronic tuberculosis infection;
- Other disorders with clinical significance according to the researcher's judgment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
The First Bethune Hospital of Jilin University
Changchun, China
The First People's Hospital of Changzhou
Changzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Jiangyin Peoples Hospital
Jiangyin, China
Qilu Hospital of Shangdong University
Jinan, China
Shandong Cancer Hospital
Jinan, China
The First People's Hospital of Kunshan
Kunshan, China
Jiangsu Cancer Hospital
Nanjing, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Drum Tower Hospital
Nanjing, China
Affiliated Hospital of Nantong University
Nantong, China
The First Hospital of China Medical University
Shenyang, China
Second Affiliated Hospital of Soochow University
Suzhou, China
Suzhou Municipal Hospital
Suzhou, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Weihai Municipal Hospital
Weihai, China
Affiliated Hospital of Jiangnan University
Wuxi, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2021
First Posted
November 10, 2021
Study Start
November 1, 2021
Primary Completion
October 31, 2024
Study Completion
April 30, 2025
Last Updated
November 10, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share