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New treatment option for HER2-expressing Advanced Solid Tumors
Official title A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT06015048
What this study is testing
What is SHR-A1811 combined with Pyrotinib.?
SHR-A1811 combined with Pyrotinib. is an investigational medicine, being studied as a potential treatment for her2-expressing advanced solid tumors.
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 SHR-A1811 combined with other antitumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-A1811 combined with other antitumor therapies for advanced solid tumors.
- 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
- Able and willing to provide a written informed consent. Have good compliance and cooperated with follow-up visits.
- people are older than or equal to 18 years old and younger than or equal to 75 years old on the day of signing the informed consent. Male or female.
- ECOG score 0-1.
- Life expectancy is at least 12 weeks.
- Histologically or cytologically confirmed metastatic or advanced unresectable HER2-expression or Her-2 functional mutations solid tumors.
You likely can't join if
- people with untreated or known active CNS metastasis. people with a history of meningeal metastasis or known active meningeal metastasis.
- Have a history of antibody drug conjugate with following characteristics: topoisomerase I inhibitors, including Enhertu (DS-8201a), U3-1402, etc...
- Palliative radiotherapy within 14 days prior to initial administration. people who had received systemic anti-tumor therapy within 4 weeks prior to...
- Toxicity and/or complications of previous interventions were not recovered to NCI-CTCAE ≤ grade 1 or didn't meet this inclusion criteria and...
- Have a history of (non-infectious) interstitial lung disease (ILD). Suspected ILD. Other moderate and severe lung diseases that may interfere the...
- Patients unable to swallow orally administered medication and other disorders likely to interfere the absorption of the study drugs within 28 days...
See the full eligibility criteria
Who can join
- Able and willing to provide a written informed consent. Have good compliance and cooperated with follow-up visits.
- people are older than or equal to 18 years old and younger than or equal to 75 years old on the day of signing the informed consent. Male or female.
- ECOG score 0-1.
- Life expectancy is at least 12 weeks.
- Histologically or cytologically confirmed metastatic or advanced unresectable HER2-expression or Her-2 functional mutations solid tumors.
- Provide ≥ 6(or ≥8)sections of formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimen sections. Sections should be archived within 1 year before the first study treatment or freshly obtained...
- ≥1 Measurable lesions, according to the Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1. The dose escalation phase allows for the absence of measurable lesions.
- Organ function met criteria within 7 days prior to initial administration (No blood component or cell growth factor was used within 14 days before the initial administration):
- Left ventricular ejection fraction (LVEF) ≥ 50% at baseline within 28 days prior to initial administration.
- Males and women of childbearing age must use reliable contraception from the written informed consent to 7 months after last drug administration (SHR-A1811) or 8 weeks after last drug administration (Pyrotinib) or 6...
What rules you out
- people with untreated or known active CNS metastasis. people with a history of meningeal metastasis or known active meningeal metastasis.
- Have a history of antibody drug conjugate with following characteristics: topoisomerase I inhibitors, including Enhertu (DS-8201a), U3-1402, etc. Part A: Have a history of Her-2 targeted tyrosine-kinase inhibitor (TKI).
- Palliative radiotherapy within 14 days prior to initial administration. people who had received systemic anti-tumor therapy within 4 weeks prior to initial administration will not permitted. The interval between the end...
- Toxicity and/or complications of previous interventions were not recovered to NCI-CTCAE ≤ grade 1 or didn't meet this inclusion criteria and exclusion criteria. If investigator determines that the toxicity and/or...
- Have a history of (non-infectious) interstitial lung disease (ILD). Suspected ILD. Other moderate and severe lung diseases that may interfere the detection or management of drug-related pulmonary toxicity and severely...
- Patients unable to swallow orally administered medication and other disorders likely to interfere the absorption of the study drugs within 28 days before the first test drug administration.
- Patients with moderate and severe ascites of clinical symptoms Refractory or moderate to severe pleural effusion or pericardial effusion.
- Patients with intestinal obstruction within 6 months prior to the first test drug administration or presence of signs and symptoms of intestinal obstruction (patients can be enrolled if surgical treatment had been...
- Have clinically significant cardiovascular disease.
- Previous or combined with other malignancies except those have achieved complete remission and do not require or are not expected to require other treatment during the study period within at least 5 years prior to...
- Serious infections within 28 days prior to the first test drug administration. Active infections that had received therapeutic intravenous antibiotics within 2 weeks prior to the first test drug administration...
- Active hepatitis B or active hepatitis C infection. Active hepatitis B is defined as hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥10000 copies/ml [2000 IU/ml] during screening. Active hepatitis C is defined...
- Major surgery history other than diagnostic or biopsy surgery within 28 days prior to initial administration. Minor traumatic surgery within 7 days prior to initial administration. Non-healing wounds. Untreated bone...
- Known allergy to any component of SHR-A1811. History of severe allergic reactions to other monoclonal antibody/fusion protein drugs. Part A: known allergy to any component of Pyrotinib.
- Female people who are pregnant, in lactation period, or planning pregnancy during the study period.
- Uncontrolled mental illness and other conditions which will affect the completion of the study, such as alcohol abuse, drug or substance abuse, criminal detention, etc.
- Any other conditions that may not eligible to participate in this study according to researchers' judgment. For Part B1, people must not meet any of the following supplementary criteria at the same time, otherwise they...
- Bleeding tendency, coagulation dysfunction, or high risk of thrombosis.
- Poorly controlled hypertension after medication (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg in the case of regular anti-hypertensive therapy) and prior hypertensive crisis or...
- Severe cerebrovascular disease, including cerebrovascular accident (CVA), transient ischemic attack (TIA), and significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Nanning, Guangxi, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanchang, Jiangxi, China
- Taiyuan, Shanxi, China
- Xi’an, Shanxi, China
- Tianjin, Tianjin 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 Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Nanning, Guangxi, China; Shijiazhuang, Hebei, China; Harbin, Heilongjiang, China and 7 more location(s). 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.