A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity … (NCT04632108) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors
China199 participantsStarted 2021-01-28
Plain-language summary
This is an open label Phase 1/2 study, the purpose of the trial is to assess the safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in patients suffering from advanced or metastatic solid tumors. Patients with gastric cancer/gastroesophageal junction adenocarcinoma and pancreatic cancer are preferred.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. According to RECIST 1.1 criteria, all patients must have at least one measurable lesion, and the tumor lesions must be accurately measured in at least one dimension, and lesions previously treated with radiotherapy or local therapy are only evaluated as non-target lesions. Bone metastatic lesions are not considered as measurable lesions;
✓. ECOG performance status (PS) 0-1;
✓. The results of the laboratory tests must meet all the following criteria:
✓.Life expectancy of at least 3 months;
✓.Patients who are supposed to be enrolled into the monotherapy dose escalation study must meet all the following criteria:
✓. Patients of either gender, aged from 18 years old to 70;
✓. Patients with histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic malignant solid tumor, for whom have no standard therapy or have no access to standard therapy for various reasons.
✓.Patients who are supposed to be enrolled into the monotherapy dose expansion study must meet all the following criteria:
Exclusion criteria
✕. Patients have a history of severe allergic reactions to monoclonal antibodies or are intolerance to monoclonal antibodies, or those who are allergic to experimental drug and any component of the drug.
✕. Patients have received a treatment of whole blood or blood component transfusion or various growth factor treatments within 14 days prior to enrollment.
What they're measuring
1
Number of participants with serious adverse events (SAE) as assessed by CTCAE v5.0
Timeframe: up to 21 days following last dose
2
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
Timeframe: up to 21 or 28 days following first dose
3
Number of participants with adverse events as assessed by CTCAE v5.0
Timeframe: up to 21 days following last dose
4
Maximum Tolerated Dose (MTD）
Timeframe: up to 21 or 28 days following first dose
5
The recommended dose
Timeframe: from date of treatment start until data cut-off, up to 2 years
6
Objective response rate
Timeframe: from date of treatment start until disease progression,date of death or withdrawal from study,whichever came first, up to 2 years
✕. Patients have received anti-tumor therapy within 14 days prior to enrollment，including but not limited to radiotherapy, chemotherapy, targeted therapy, treatment with herbal medications or other treatments that have known antitumor activity . Patients who have undergone palliative radiotherapy for bone metastases and whose acute toxicity has returned to normal can be selected;
✕. Patients have received systemic immunosuppressive therapy（such as systemic corticosteroids）within 14 days prior to enrollment. However, patients using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30mg per day of hydrocortisone or 10mg per day of prednisone) are allowed；patients are allowed to receive a single dose of systemic corticosteroids treatment；
✕. Patients have participated in other clinical trials within 28 days prior to enrollment; patients who have participated monoclonal antibody clinical trials within 2 months prior to sign written informed consent form also cannot participate in this trial；
✕. Patients have received major surgical operation within 28 days prior to enrollment or schedule to perform major surgery during the period of this clinical trial;
✕. Patients have gastrointestinal diseases such as gastrinoma, duodenitis, gastric ulcer, duodenal ulcer, pancreatitis or upper gastrointestinal hemorrhage, caused by nonmalignant tumor (gastric cancer, gastroesophageal junction adenocarcinoma and pancreatic cancer)withinwithin 3 months prior to enrollment；Patients have gastric inlet and outlet obstruction or suspected obstruction within 1 months prior to enrollment；
✕. Known to have irritable bowel syndrome, ulcerative colitis, Crohn's disease, gastric outlet obstruction, etc., or any other causes that can cause long-term chronic nausea,persistent repeated vomiting or diarrhea, and uncontrolled or severe gastrointestinal bleeding;