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New treatment option for Pancreatic Cancer
Official title Exploratory Clinical Study of HRS-4642 Combined With Adebrelimab in the Treatment of Advanced Pancreatic Ductal Adenocarcinoma
ClinicalTrials.gov ID: NCT06427239
What this study is testing
What is HRS-4642?
HRS-4642 is an investigational medicine, being studied as a potential treatment for pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is being conducted to evaluate the safety, tolerability and efficacy of HRS-4642 combined with adebrelimab, or with adebrelimab and other antitumor agents in patients with advanced pancreatic ductal adenocarcinoma (PDAC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients volunteered to participate in this study and signed informed consent;
- Age: ≥18 and ≤75 years old, male or female;
- Advanced (metastatic or unresectable) Pancreatic ductal adenocarcinoma; and people must have at least one measurable lesion as defined by RECIST v1.1;
- With failure or absence of standard treatment, and progress within 6 months of adjuvant therapy can also be included in the study;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
You likely can't join if
- Known to be allergic to the investigational drug or any of its components;
- Have other active malignancies within 5 years;
- Systemic antitumor therapy was received 4 weeks before the start of the study, and palliative radiotherapy was completed within 14 days before the...
- Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation;
- Accompanied by untreated or active central nervous system (CNS) metastases;
- Within 6 months prior to entering the study, patients with severe cardiovascular and cerebrovascular thromboembolism;
See the full eligibility criteria
- Patients volunteered to participate in this study and signed informed consent;
- Age: ≥18 and ≤75 years old, male or female;
- Advanced (metastatic or unresectable) Pancreatic ductal adenocarcinoma; and people must have at least one measurable lesion as defined by RECIST v1.1;
- With failure or absence of standard treatment, and progress within 6 months of adjuvant therapy can also be included in the study;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy ≥ 12 weeks;
- Adequate marrow and organ function;
- AE caused by previous anti-tumor therapy must be restored to ≤ level 1 (CTCAE v5.0) or a stable state evaluated by the researcher, except for hair loss (any level) and peripheral neuropathy of level 2;
- Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient...
- Known to be allergic to the investigational drug or any of its components;
- Have other active malignancies within 5 years;
- Systemic antitumor therapy was received 4 weeks before the start of the study, and palliative radiotherapy was completed within 14 days before the first dose;
- Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation;
- Accompanied by untreated or active central nervous system (CNS) metastases;
- Within 6 months prior to entering the study, patients with severe cardiovascular and cerebrovascular thromboembolism;
- Hypertension with poor drug control (continuous increase in systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100mmHg);
- Late stage patients with symptoms that have spread to the internal organs and are at risk of life-threatening complications in the short term;
- With interstitial lung disease, non-infectious pneumonia, severe and uncontrolled internal medicine diseases, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);
- Participated in clinical trials of any drug or medical device within 4 weeks prior to the first administration;
- With congenital or acquired immune deficiency, such as people infected with HIV, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the...
- With any active autoimmune diseases or a history of autoimmune diseases;
- Received systemic treatment with corticosteroids or other immunosuppressants within 2 weeks prior to the first medication;
- High risk of pancreatitis, serum amylase and/or lipase concentrations ≥ 3 times ULN; who have a simple increase in lipase, will be considered for inclusion by the researchers;
- Other situations that researchers believe should not be included.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.