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CarcinomaPhase 2NCT05115500

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)

A Phase 2 study testing ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 in people with Carcinoma and Solid Tumor, run by Second Affiliated Hospital of Soochow University at 19 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Solid Tumor
What is being tested?
ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
19 sitesChina
Study dates
1 Nov 2021to 30 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

19 sites in 1 country.

Liyuan Zhang, doctor contact

0512-67784829

zhangliyuan126@126.com

19 sites in 1 country

China19 sites

  • The First Bethune Hospital of Jilin University

    Changchun

    Xin Jiang

  • The First People's Hospital of Changzhou

    Changzhou

    Wendong Gu

  • Harbin Medical University Cancer Hospital

    Harbin

    Lili Yu

  • Jiangyin Peoples Hospital

    Jiangyin

    Jian Wang

  • Qilu Hospital of Shangdong University

    Jinan

    Bingxu Tan

  • Shandong Cancer Hospital

    Jinan

    Dali Han

  • The First People's Hospital of Kunshan

    Kunshan

    Minbin Chen

  • Jiangsu Cancer Hospital

    Nanjing

    Li Yin

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing

    Dahai Yu

  • Jiangsu Province Hospital

    Nanjing

    Yuandong Cao

  • Nanjing Drum Tower Hospital

    Nanjing

    Jing Yan

  • Affiliated Hospital of Nantong University

    Nantong

    Xiancheng Liu

  • The First Hospital of China Medical University

    Shenyang

    Qiao Qiao

  • Second Affiliated Hospital of Soochow University

    Suzhou

    Liyuan zhang

  • Suzhou Municipal Hospital

    Suzhou

    Jundong Zhou

  • The First Affiliated Hospital of Soochow University

    Suzhou

    songbing Qin

  • Weihai Municipal Hospital

    Weihai

    Fujun Yang

  • Affiliated Hospital of Jiangnan University

    Wuxi

    Ke Gu

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

    Jianshe Wang

Other trials in China

About this study

Official title: 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)

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

Being tested
ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2
Medical subject headings
Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT05115500
Study groupRoleWhat they receive
ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2ExperimentalNot described
Receives: Drug: ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate （ORR）

    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).

    Measured: 24 months

Secondary outcomes (4)

  1. Progression-free Survival (PFS)

    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.

    Measured: 24 months

  2. Disease control rate (DCR)

    DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD)

    Measured: 24 months

  3. Overall survival (OS)

    OS was defined as the time from the first administration of study treatment to death from any cause.

    Measured: 24 months

  4. Adverse event

    rate of adverse events

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2021
  2. Study start1 Nov 2021 (estimated)
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05115500
Sponsor's protocol ID
JD-LK-2021-121-01
Status last verified
Nov 2021
First submitted
4 Nov 2021
Last updated
10 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 in people with Carcinoma and Solid Tumor, run by Second Affiliated Hospital of Soochow University at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liyuan Zhang, doctor (0512-67784829, zhangliyuan126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate （ORR） (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05115500.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.

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