Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IND161926 | Other Identifier | FDA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GCP ClinPlus Co., Ltd. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This study is a multicenter, open-label, multi-cohort investigation exploring the efficacy and safety of ABP1011T tablets in participants with specific target solid tumors, providing a foundation for subsequent clinical research.
Based on safety and efficacy data from the prior Phase I/IIa clinical trial (Protocol Number: ABP1011T-I/II-01), priority enrollment is given to participants with advanced solid tumors including small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, and renal cell carcinoma (excluding osteosarcoma). Cohort A (Cohort A1, Cohort A2, Cohort A3) comprises the small cell lung cancer cohort: Participants must have failed at least two prior systemic therapies. Cohort B enrolls participants with other advanced solid tumors (excluding osteosarcoma).
ABP1011T tablets are administered as continuous therapy in clinical studies, with a 21-day treatment cycle. Participants take one tablet orally once daily on an empty stomach (with water, avoiding food for at least 1 hour before and after each dose).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABP1011T Tablets in Patients with Advanced Solid Tumor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP1011T | Drug | ABP1011T tablets are administered as continuous therapy in clinical studies, with a 21-day treatment cycle. Participants take one tablet orally once daily on an empty stomach (with water, avoiding food for at least 1 hour before and after each dose). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Relief (DOR) | DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first. | Up to approximately 2 years |
| Progression-Free Survival (PFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. History of or current presence of other malignant tumors, except for the following:
1) Completely resected basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ; 2) Completely resected secondary primary cancer with no recurrence within five years; 2. Patients with known hypersensitivity to any component of the study drug or similar agents, or with a history of severe allergic reactions; 3. Patients who have received any of the following treatments or medications prior to the first study treatment: 1) Major surgery or severe trauma within 4 weeks before the first study drug administration (Major surgery is defined as any invasive procedure involving extensive excision or breaching of the mesothelial barrier, such as the pleural cavity, peritoneum, or meninges. However, diagnostic tissue biopsies are permitted). Severe trauma refers to unhealed wounds, ulcers, or fractures; 2) Received Chinese herbal medicine or traditional Chinese medicine for antitumor indications within 2 weeks prior to the first study drug dose.
3) Received antitumor therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biologic therapy, or tumor embolization) within 4 weeks prior to the first study drug dose; For oral fluoropyrimidine drugs and endocrine therapy, discontinuation <= 2 weeks or 5 half-lives; for nitrosoureas and mitomycin, discontinuation <= 6 weeks. If washout time is inadequate due to scheduling or drug PK characteristics, discussion with the sponsor is required; 4) Wthin 1 week prior to first dose, received potent CYP3A4 or CYP2C9 inhibitors or inducers; 5) Within 1 week prior to first dose, received drugs known to significantly prolong the QT interval (e.g., Class Ia and Class III antiarrhythmics); 6) Concurrent use of antiplatelet agents or anticoagulants during the screening period that cannot be discontinued; 4. Patients with known brain metastases, brainstem metastases, spinal cord metastases, and/or compression, or unstable central nervous system metastases. (However, the following situations may be determined through discussion between the investigator and sponsor: If asymptomatic, or with stable brain metastasis symptoms, and if steroids, anticonvulsants, or mannitol therapy has not been used or has been discontinued for >=4 weeks prior to the first study dose, and the investigator determines the benefits outweigh the risks, the subject may be considered for screening and enrollment); 5. Patients with symptomatic, disseminated visceral disease at an advanced stage who are at risk of life-threatening complications in the short term, or patients with pleural effusion, ascites, or pericardial effusion who underwent paracentesis or thoracentesis within three weeks prior to the first study dose; 6. Patients with imaging evidence of tumor encasement or infiltration of major vessels (e.g., pulmonary artery, pulmonary vein, superior vena cava, inferior vena cava), or significant tumor invasion into adjacent organs (aorta, trachea, gastrointestinal tract) adjacent to esophageal or gastrointestinal lesions, resulting in high risk of hemorrhage or fistula formation; and patients who have undergone tracheal stent placement.
7. Within 6 months prior to screening, presence of cardiovascular disease meeting any of the following criteria: 1) Congestive heart failure with cardiac function >= New York Heart Association (NYHA) Class II; left ventricular ejection fraction (LVEF) < 50%; 2) Severe arrhythmia requiring medication; 3) QTcF (Fridericia formula) > 450 msec in males or > 470 msec in females, or presence of risk factors for torsades de pointes, such as clinically significant hypokalemia as determined by the investigator, history of familial long QT syndrome, or familial arrhythmia history (e.g., Wolff-Parkinson-White syndrome); and abnormal troponin levels; 4) Myocardial infarction, severe/unstable angina, cardiac revascularization, cerebrovascular accident, or similar events within six months prior to dosing; 5) History of >= Grade 3 thromboembolic events within the past 2 years, or currently receiving thrombolytic or anticoagulant therapy due to high thrombotic risk; 8. Electrolite disturbances during screening; 9. Uncontrolled systemic diseases despite treatment, such as diabetes; 10. Current acute pulmonary disease, interstitial lung disease or pneumonia, pulmonary fibrosis, acute pulmonary disease, or treatable reflex interstitial pneumonia; 11. Patients with a clear tendency toward gastrointestinal bleeding, including the following conditions: presence of locally active ulcerative lesions with fecal occult blood test (>=2+); history of melena or hematemesis within the past 2 months; patients deemed by the investigator to be at risk for major gastrointestinal hemorrhage; 12. History of or current unhealed gastrointestinal perforation or visceral fistula; 13. Evidence of active infection:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiping WANG, PhD | Contact | +86 21 5442 6122 | 8006 | hpwang@abpharma.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Henan University of Science and Technology | Not yet recruiting | Luoyang | Henan | China |
The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.
Not provided
After the trial completed.
NCI is committed to sharing data in accordance with NIH policy.
Not provided
Not provided
Based on safety and efficacy data from the prior Phase I/IIa clinical trial (Protocol Number: ABP1011T-I/II-01), priority enrollment is given to participants with advanced solid tumors including small cell lung cancer, esophageal cancer, cervical cancer, bladder cancer, and renal cell carcinoma (excluding osteosarcoma). Cohort A (Cohort A1, Cohort A2, Cohort A3) comprises the small cell lung cancer cohort: Participants must have failed at least two prior systemic therapies. Cohort B enrolls participants with other advanced solid tumors (excluding osteosarcoma).
Not provided
Not provided
Not provided
Not provided
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1). |
| Up to approximately 2 years |
| Disease Control Rate (DCR) | DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1. | Up to approximately 2 years |
| Sustained Response Rate | Proportion of subjects with DoR ≥ 6 months after first dose (based on RECIST v1.1). | Up to approximately 2 years |
| Overall Survival (OS) | OS is the time from the date of first dosing date to death due to any cause. | Up to approximately 2 years |
| Two-Year Overall Survival Rate | Two-Year Overall Survival Rate | Up to approximately 2 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Up to approximately 2 years |
| The First Affiliated Hospital of Nanyang Medical College | Not yet recruiting | Nanyang | Henan | China |
|
| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | China |
|
| Liaocheng Second People's Hospital | Recruiting | Liaocheng | Shandong | China |
|
| Shanghai Pulmonary Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| Shanxi Bethune Hospital | Not yet recruiting | Taiyuan | Shanxi | China |
|
| Neijiang First People's Hospital | Recruiting | Neijiang | Sichuan | China |
|
| Shanghai East Hospital | Recruiting | Shanghai | China |
|