Cancer Clinical Trial
Official title:
A Phase 1, Open-Label, Dose-Finding Study Of ASN007 In Patients With Advanced Solid Tumors
Verified date | July 2020 |
Source | Asana BioSciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is divided into two parts. The first part of the study will test various doses of ASN007 to find out the highest safe dose to test in five specific groups. The second part of the study will test how well ASN007 can control cancer.
Status | Completed |
Enrollment | 49 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Written informed consent obtained prior to any study-related procedure being performed; - Male or non-pregnant, non-lactating female patient at least 18 years of age at the time of consent; - Eastern Cooperative Oncology Group Performance Status 0-1 (Part A) and PS 0-2 (Part B) - Histologically or cytologically confirmed - advanced or metastatic solid tumor (Part A) - Group 1: BRAF mutant melanoma (Part B) - Group 2: NRAS or HRAS mutant solid tumors(Part B) - Group 3: KRAS mutant CRC.(Part B) - Group 4: KRAS mutant NSCLC (Part B) - Group 5: Pancreatic Ductal Adenocarcinoma (Part B) - Progressive disease after failure of or intolerant to all available standard systemic treatments that have shown a documented benefit in overall survival for their respective tumor type. - Measurable or evaluable disease per RECIST v1.1 - Screening hematology values of the following: - absolute neutrophil count = 1000/µL, - platelets = 100,000/µL, - hemoglobin = 9 g/dL - Screening chemistry values of the following: - alanine aminotransferase (ALT) and aspartate transaminase (AST) = 3.0 × upper limit of the normal (ULN), - total bilirubin = 1.5 × ULN, - creatinine = 1.5 × ULN,, - albumin = 2.8 g/dL. - Screening heart function lab test - creatinine kinase - MB, troponin-I, and troponin-T within normal limits - Subject is willing and able to comply with all protocol required visits and assessments, including biopsy if assigned. Exclusion Criteria: - Prior treatment with ASN007 or another ERK1/2 inhibitor - Known hypersensitivity to ASN007 or its excipients; - Part B: Prior treatment with a RAF or MEK pathway inhibitor, except BRAFmutant melanoma (Group 1) - Prior chemotherapy, targeted therapy or monoclonal antibody therapy within 3 weeks of start of study treatment (Day1), or 5 half-lives, whichever is shorter. - Concurrent or prior bone marrow factors (e.g. G-CSF, GM-CSF or erythropoietin) within 3 weeks prior to Day 1 of treatment. - Febrile neutropenia or serious persistent infection within 2 weeks prior to Day 1 of treatment - Failure to recover from major surgery or traumatic injury within 4 weeks or minor surgery within 2 weeks prior to Day 1 of treatment. - History of or current evidence / risk of retinal vein occlusion (RVO) central serous retinopathy (CSR), or glaucoma with intraocular pressures = 21 mmHg or other pre-existing ocular conditions that may put the patient at risk for ocular toxicities - Known central nervous system (CNS) primary tumor, CNS metastases or carcinomatous meningitis (Part A). Patients may be enrolled with CNS metastasis in certain circumstances in Part B. - Clinically significant heart disorders including an ejection fraction of < 50% - Other serious uncontrolled conditions such as fungal, bacterial or viral infection; HIV, Hepatitis B or C, bleeding disorders, interstitial lung disease, - Any other condition that might place the patient at undue risk. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | NEXT Oncology | San Antonio | Texas |
United States | South Texas Accelerated Research Therapeutics | San Antonio | Texas |
United States | H. Lee Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Asana BioSciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To evaluate the change from baseline in the intensity of phosphorylated ribosomal S6 kinase (RSK) found in tumor biopsies. | Evaluate the effect of ASN007 on biomarkers | Through the study, average 6 months | |
Other | Evaluate the change from baseline in the amount of circulating tumor DNA | Evaluate the effect of ASN007 on biomarkers | Every 8 weeks for the first 24 weeks, then every 12 weeks for up to 1 year | |
Primary | Part A: Determine the maximum tolerated dose (MTD) of ASN007 | The MTD will be determined by evaluating the number of subjects with treatment related dose limiting toxicity. This is the primary endpoint of Part A | First 21 days | |
Primary | Part B: evaluate the overall response rate (number of Complete Responses + Partial Responses) in subjects receiving ASN007 for the treatment of metastatic melanoma, CRC, NSCLC, or pancreatic cancer. | This is the primary endpoint for Part B. | First 6 months | |
Secondary | Calculate the pharmacokinetic area under the plasma concentration (AUC) of ASN007 | Calculate the amount of ASN007 in the bloodstream | First 21 days | |
Secondary | Calculate the maximum plasma concentration (Cmax) at steady state. | Calculate the maximum amount of ASN007 in the bloodstream | First 21 days | |
Secondary | Calculate the terminal elimination rate (T 1/2). | Calculate how fast ASN007 leaves the body | First 21 days |
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