Adebrelimab (SHR-1316)Phase 1/2NCT06454448
Phase Ib/II Clinical Study of Adebrelimab in Combination With Decitabine, Albumin-bound Paclitaxel, and Gemcitabine for the First-line Treatment of Metastatic Pancreatic Cancer
A Phase 1/2 study testing Adebrelimab;decitabine; in people with Adebrelimab (SHR-1316) and Decitabine, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Pancreatic cancer is a kind of digestive system tumor with extremely high malignancy and poor prognosis. Although the trend of benefit from immunotherapy in combination with chemotherapy is currently reflected in several exploratory studies, the overall efficacy is still relatively limited. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adebrelimab (SHR-1316), Decitabine, Metastatic Pancreatic Cancer
- What is being tested?
- Adebrelimab;decitabine;
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2024to Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age 18-75 years old, male or female; 2. Histologically or cytologically confirmed diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th edition TNM staging of pancreatic cancer); 3. Have not received any anti-tumor therapy (including chemotherapy, targeted, immunotherapy, etc.); 4. Must have at least one measurable lesion as a target lesion (according to RECIST v1.1 criteria); the target lesion should not have received localized treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to have occurred and meets RECIST1.1 criteria); 5. ECOG: 0 to 1; 6. Expected survival ≥ 3 months; 7. Good major organ function, i.e., the following criteria are met (in the absence of receiving any blood components, cell growth factors within 14 days prior to randomization):
- Neutrophils ≥1.5*109/L; platelets ≥80*109/L; hemoglobin ≥9g/dl; serum albumin ≥3g/dl;
- Total bilirubin ≤ 1.5 times the upper limit of normal value (biliary obstruction allows biliary drainage); ALT and AST ≤ 3 times the upper limit of normal value (for patients with hepatic metastases, it can be relaxed to ≤ 5 times the upper limit of normal value);
- Serum creatinine ≤1.5 times the upper limit of normal value, creatinine clearance ≥50ml/min;
- INR ≤1.5 times the upper limit of normal value and APTT ≤1.5 times the upper limit of normal value (for the use of a stable dose of anticoagulation therapy, such as low molecular heparin or warfarin, and the INR is within the expected therapeutic range of anticoagulants can be screened);
- Electrocardiogram: QTcF ≤450ms (men), ≤470ms (women);
- Cardiac ultrasound: LVEF (left ventricular ejection fraction) ≥50%; 8. Women of childbearing potential must have had a negative blood pregnancy test within 3 days prior to randomization and be willing to use an appropriate method of contraception during the trial and for 6 months after completion of treatment. For men, this should be surgical sterilization or agreement to use an appropriate method of contraception for the duration of the study and for 3 months after completion of treatment; 9. Subjects voluntarily enroll in this study by signing an informed consent form.
Who cannot join
- patients with pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic follicular cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumors;
- patients with known central nervous system metastases;
- severe gastrointestinal dysfunction (with bleeding, obstruction; inflammation greater than grade 2; diarrhea greater than grade 1);
- the presence of third interstitial fluid (e.g., massive pleural fluid) that could not be stabilized (without interventional therapy after drain removal) except for ascites within 2 weeks before randomization;
- Patients with clinically symptomatic ascites who require puncture or drainage or who have received ascites drainage within the previous 3 months (except for imaging that shows only a small amount of ascites that is manageable but not accompanied by clinical symptoms);
- current concomitant interstitial pneumonia or interstitial lung disease, or a prior history of interstitial pneumonia or interstitial lung disease requiring hormonal therapy, or other pulmonary fibrosis that may interfere with the determination and management of immune-related pulmonary toxicity, mechanized pneumonia (e.g., occlusive bronchiectasis), pneumoconiosis, drug-associated pneumonitis, idiopathic pneumonitis, or active pneumonia or severely impaired pulmonary function as demonstrated by chest CT at the Screening Period Subjects; active tuberculosis;
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- the presence of active autoimmune disease or a history of autoimmune disease with potential for relapse [including, but not limited to, autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (subjects who can be controlled by hormone replacement therapy only are eligible for enrollment)]; subjects who have a skin disease that does not require systemic treatment such as vitiligo, psoriasis, alopecia that Controlled type I diabetes mellitus receiving insulin therapy or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be enrolled;
- known peripheral neuropathy (CTCAE ≥ grade 3);
- a serious infection (CTCAE > grade 2) within 4 weeks prior to randomization, such as severe pneumonia, bacteremia, or complications of infection requiring hospitalization; signs and symptoms of infection requiring intravenous antibiotic therapy (except for prophylactic use of antibiotics) within 2 weeks prior to randomization;
- received any of the following treatments: 1) Immunosuppressive or systemic hormone therapy for immunosuppression within 2 weeks prior to randomization (dose >10 mg/day prednisone or other equipotent hormone); 2) Radiation therapy within 2 weeks prior to randomization; 3) Major surgery (e.g., open thoracic surgery, open abdominal surgery, etc.) within 4 weeks prior to randomization; 4) Received any other clinical study medication within 4 weeks prior to randomization, unless it was an observational (non-interventional) clinical study or an interventional clinical study follow-up.
- abnormal coagulation, bleeding tendency or undergoing thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (≤100mg/day), low molecular heparin (enoxaparin 40mg/day and other low molecular heparin at its equivalent dose) is allowed;
- patients with cardiac clinical conditions or diseases that are not well controlled, such as (1) NYHA class 2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 6 months, and (4) clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;
- malignancy other than pancreatic cancer within 5 years prior to randomization, with the exception of adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell carcinoma of the skin;
- known hypersensitivity to PD-L1, albumin paclitaxel, gemcitabine, decitabine, and any of the components of the above products;
- known to have acquired immunodeficiency syndrome (AIDS) or HIV test positive, active syphilis infection;
- previous history of definite neurological or psychiatric disorders, including epilepsy or dementia;
- Subjects who, in the judgment of the investigator, have other factors that may cause them to be forced to terminate the study midway, such as non-compliance with the protocol, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, grossly abnormal values of clinically significant laboratory tests, familial or social factors that may affect the safety of the subject or the collection of trial data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300052
Rui Liu, 13602139003, ruiliu688@126.com
About this study
Pancreatic cancer is a kind of digestive system tumor with extremely high malignancy and poor prognosis. Although the trend of benefit from immunotherapy in combination with chemotherapy is currently reflected in several exploratory studies, the overall efficacy is still relatively limited.
Dysregulation of epigenetic mechanisms, which is common in cancer, leads to down-regulation of genes involved in tumor antigen processing or presentation, resulting in immune evasion and thus affecting the efficacy of immunotherapy. Epigenetic inhibitors may enhance the efficacy of immunotherapy by enhancing antigenicity and presentation of tumor-associated antigens, reprogramming the tumor microenvironment to counteract immunosuppression, and reversing cytotoxic T-cell depletion. Thus, decitabine-promoted immunotherapeutic sensitization is a potential therapeutic avenue for mPDAC patients that warrants further exploration in clinical trials. Taking into account the characteristics of pancreatic cancer immunophenotype, exploring combination therapy regimens that enhance anti-tumor immune response and improve the efficacy of immunotherapy has become an urgent clinical problem.
This study is a prospective, single-arm, single-center, phase IB/II clinical study exploring the efficacy and safety of adebrelimab in combination with decitabine, albumin-bound paclitaxel, and gemcitabine in the first-line treatment of metastatic pancreatic cancer. The primary study endpoints are DLT, RP2D and ORR. Secondary study endpoints are OS, PFS, DCR, DoR and safety.
- Being tested
- Adebrelimab;decitabine;
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab;decitabine;Drug
Adebrelimab:1200 mg Decitabine:10mg/m2 or 15mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | 1. Decitabine: RP2D dose, continuous infusion over 1 hr, D1-D3.
2. Albumin paclitaxel: dose of 125 mg/m2, IV infusion over 30-40min, D1, D8, D15
3. Gemcitabine: dose of 1000 mg/m2, IV infusion over at least 30min, D1, D8, D15
4. Adebrelimab: 1200 mg by IV infusion over 30-60 min, D15, Q3W In case of AG (albumin paclitaxel + gemcitabine) treatment-related adverse events during the treatment period, dose adjustment of the AG regimen may be appropriately allowed, with the gemcitabine dose adjusted from 1000 mg/m2 to 800 mg/m2. chemotherapy is administered in 1 treatment cycle every 28 days. Receives: Drug: Adebrelimab;decitabine; |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Any adverse event of a certain observation period (within 28 days of the first dose) that is related to the study medication and meets a CTCAE of grade 3 or higher
Measured: Within 28 days of initial administration
The recommended phase 2 dose (RP2D)
The recommended phase 2 dose
Measured: Within 28 days of initial administration
Objective Response Rate (ORR)
The objective response rate is estimated by the proportion (percentage) of participants with the best response of complete response (CR), or partial response (PR) by RECIST 1.1 criteria
Measured: Up to 12months
Secondary outcomes (5)
Overall Survival (OS)
Overall Survival (OS) (median) was determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
Measured: Up to 2 years
Progression-free Survival (PFS)
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants.
Measured: up to 6 months
Disease Control Rate (DCR)
The objective response rate is estimated by the proportion (percentage) of participants with the best response of complete response (CR), partial response (PR) and stable disease(SD) by RECIST 1.1 criteria
Measured: Up to 1 year
During of response (DoR)
Estimated by the proportion (percentage) of participants with the time from the first recording of tumor remission (i.e., CR or PR, according to the appropriate criteria) to the first recording of disease progression (PD, according to the appropriate criteria) or death from any cause, whichever occurs first.
Measured: Up to 1 year
AE/SAE
Incidence of Adverse Events (AE)/Serious Adverse Events (SAE) (as measured by NCI-CTCAE 5.0)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start15 Jun 2024
- Primary completionJun 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adebrelimab (SHR-1316)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454448
- Sponsor's protocol ID
- PC first line
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Clinical Study of Adebrelimab in Combination With Decitabine, Albumin-bound Paclitaxel, and Gemcitabine for the First-line Treatment of Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06454448
- Acronym / sponsor ID
- PC first line
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic cancer is a kind of digestive system tumor with extremely high malignancy and poor prognosis. Although the trend of benefit from immunotherapy in combination with chemotherapy is currently reflected in several exploratory studies, the overall efficacy is still relatively limited.
Dysregulation of epigenetic mechanisms, which is common in cancer, leads to down-regulation of genes involved in tumor antigen processing or presentation, resulting in immune evasion and thus affecting the efficacy of immunotherapy. Epigenetic inhibitors may enhance the efficacy of immunotherapy by enhancing antigenicity and presentation of tumor-associated antigens, reprogramming the tumor microenvironment to counteract immunosuppression, and reversing cytotoxic T-cell depletion. Thus, decitabine-promoted immunotherapeutic sensitization is a potential therapeutic avenue for mPDAC patients that warrants further exploration in clinical trials. Taking into account the characteristics of pancreatic cancer immunophenotype, exploring combination therapy regimens that enhance anti-tumor immune response and improve the efficacy of immunotherapy has become an urgent clinical problem.
This study is a prospective, single-arm, single-center, phase IB/II clinical study exploring the efficacy and safety of adebrelimab in combination with decitabine, albumin-bound paclitaxel, and gemcitabine in the first-line treatment of metastatic pancreatic cancer. The primary study endpoints are DLT, RP2D and ORR. Secondary study endpoints are OS, PFS, DCR, DoR and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: Adebrelimab;decitabine;1. Decitabine: RP2D dose, continuous infusion over 1 hr, D1-D3. 2. Albumin paclitaxel: dose of 125 mg/m2, IV infusion over 30-40min, D1, D8, D15 3. Gemcitabine: dose of 1000 mg/m2, IV infusion over at least 30min, D1, D8, D15 4. Adebrelimab: 1200 mg by IV infusion over 30-60 min, D15, Q3W In case of AG (albumin paclitaxel + gemcitabine) treatment-related adverse events during the treatment period, dose adjustment of the AG regimen may be appropriately allowed, with the gemcitabine dose adjusted from 1000 mg/m2 to 800 mg/m2. chemotherapy is administered in 1 treatment cycle every 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Age 18-75 years old, male or female; 2. Histologically or cytologically confirmed diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th edition TNM staging of pancreatic cancer); 3. Have not received any anti-tumor therapy (including chemotherapy, targeted, immunotherapy, etc.); 4. Must have at least one measurable lesion as a target lesion (according to RECIST v1.1 criteria); the target lesion should not have received localized treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to have occurred and meets RECIST1.1 criteria); 5. ECOG: 0 to 1; 6. Expected survival ≥ 3 months; 7. Good major organ function, i.e., the following criteria are met (in the absence of receiving any blood components, cell growth factors within 14 days prior to randomization):
- Neutrophils ≥1.5*109/L; platelets ≥80*109/L; hemoglobin ≥9g/dl; serum albumin ≥3g/dl;
- Total bilirubin ≤ 1.5 times the upper limit of normal value (biliary obstruction allows biliary drainage); ALT and AST ≤ 3 times the upper limit of normal value (for patients with hepatic metastases, it can be relaxed to ≤ 5 times the upper limit of normal value);
- Serum creatinine ≤1.5 times the upper limit of normal value, creatinine clearance ≥50ml/min;
- INR ≤1.5 times the upper limit of normal value and APTT ≤1.5 times the upper limit of normal value (for the use of a stable dose of anticoagulation therapy, such as low molecular heparin or warfarin, and the INR is within the expected therapeutic range of anticoagulants can be screened);
Key exclusion criteria (17 listed)
- patients with pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic follicular cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumors;
- patients with known central nervous system metastases;
- severe gastrointestinal dysfunction (with bleeding, obstruction; inflammation greater than grade 2; diarrhea greater than grade 1);
- the presence of third interstitial fluid (e.g., massive pleural fluid) that could not be stabilized (without interventional therapy after drain removal) except for ascites within 2 weeks before randomization;
- Patients with clinically symptomatic ascites who require puncture or drainage or who have received ascites drainage within the previous 3 months (except for imaging that shows only a small amount of ascites that is manageable but not accompanied by clinical symptoms);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adebrelimab;decitabine;Adebrelimab:1200 mg Decitabine:10mg/m2 or 15mg/m2 | Drug | Study arm |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: Within 28 days of initial administration
Any adverse event of a certain observation period (within 28 days of the first dose) that is related to the study medication and meets a CTCAE of grade 3 or higher
The recommended phase 2 dose (RP2D)
Time frame: Within 28 days of initial administration
The recommended phase 2 dose
Objective Response Rate (ORR)
Time frame: Up to 12months
The objective response rate is estimated by the proportion (percentage) of participants with the best response of complete response (CR), or partial response (PR) by RECIST 1.1 criteria
5 secondary outcomes
Overall Survival (OS)
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: up to 6 months
Disease Control Rate (DCR)
Time frame: Up to 1 year
During of response (DoR)
Time frame: Up to 1 year
AE/SAE
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
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RecruitingPhase 2
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RecruitingPhase 3
A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer
Triple Negative Breast Cancer
Not yet recruitingPhase 2
An Exploratory Clinical Study of Accurate Efficacy Assessment of Neoadjuvant Immunotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma Based on 68Ga-FAPI ([68Ga] Fibroblast Activation Protein Inhibitor)/¹⁸F-FDG (2-Deoxy-2-[¹⁸F]Fluoro-D-glucose) Dual Imaging
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RecruitingPhase 2/3
Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
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RecruitingPhase 3
Clinical Study of Adebrelimab Therapy in the Perioperative Treatment of Gastric Cancer or Gastroesophageal Junction Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adebrelimab;decitabine; in people with Adebrelimab (SHR-1316) and Decitabine, run by Tianjin Medical University Cancer Institute and Hospital at 1 site 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 7 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: Within 28 days of initial administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2024.