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Trial record 6 of 80 for:    ASNS

A Study of ASN007 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03415126
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Asana BioSciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Malignancy Neoplasia Neoplasm Neoplasm Metastasis Colon Cancer Colonic Neoplasms Colon Cancer Liver Metastasis Metastatic Cancer Metastatic Melanoma Metastatic Colon Cancer Metastatic Lung Cancer Non Small Cell Lung Cancer Metastatic Pancreatic Cancer Pancreas Cancer Pancreas Adenocarcinoma Pancreas Neoplasm Metastatic Nonsmall Cell Lung Cancer Metastatic Pancreatic Cancer Drug: ASN007: ascending doses Drug: ASN007 RD Phase 1

Detailed Description:

Part A is a dose escalation study to determine a safe and tolerable dose of ASN007 for patients with advanced solid tumors. Part A will also describe how the body works on ASN007(pharmacokinetics) and the effects of ASN007 on the body (pharmacodynamics) of ASN007, through blood sampling and optional biopsies..

Part B of the study will enroll patients with particular tumor types and genetic mutations for treatment at the Recommended Phase 2 Dose. Part B will enroll patients in five groups of fifteen patients each:

Group 1: Patients with metastatic BRAF mutated melanoma Group 2: Patients with metastatic NRAS and HRAS mutated solid tumors Group 3: Patients with metastatic KRAS mutated colorectal cancer (CRC) Group 4: Patients with metastatic KRAS mutated non-small cell lung cancer (NSCLC) Group 5: Patients with metastatic pancreatic ductal adenocarcinoma (PDAC) Patients with melanoma will be required to have pre-dose and post-dose biopsies.

Group 6: Patients with metastatic MEK1, BRAF V600E, non-BRAF V600E solid tumors or BRAF fusions without prior treatment with BRAF, MEK, ERK inhibitors


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Finding Study Of ASN007 In Patients With Advanced Solid Tumors
Actual Study Start Date : January 19, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Asparagine

Arm Intervention/treatment
Experimental: ASN007 ascending doses
Patients will receive escalating doses of ASN007 to identify the best dose.
Drug: ASN007: ascending doses
Oral drug for the treatment of advanced solid tumors

Experimental: ASN007 RD: KRAS mutant Melanoma
Patients with BRAF mutant metastatic melanoma will receive the recommended dose from Part A.
Drug: ASN007 RD
Oral drug for the treatment of advanced solid tumors

Experimental: ASN007 RD: NRAS mutant Melanoma
Patients with NRAS and HRAS mutant solid tumors will receive the recommended dose from Part A.
Drug: ASN007 RD
Oral drug for the treatment of advanced solid tumors

Experimental: ASN007 RD: KRAS mutant metastatic CRC
Patients with KRAS mutant CRC will receive the recommended dose from Part A
Drug: ASN007 RD
Oral drug for the treatment of advanced solid tumors

Experimental: ASN007 RD: KRAS mutant NSCLC
Patients with KRAS mutant NSCLC will receive the recommended dose from Part A
Drug: ASN007 RD
Oral drug for the treatment of advanced solid tumors

Experimental: ASN007 RD: Metastatic Pancreatic Cancer
Patients with pancreatic adenocarcinoma will receive the recommended dose from Part A
Drug: ASN007 RD
Oral drug for the treatment of advanced solid tumors

Experimental: ASN007 RD: MEK, All BRAF, BRAF-fusion cancers
Patients with solid tumors will receive the recommended dose from Part A
Drug: ASN007 RD
Oral drug for the treatment of advanced solid tumors




Primary Outcome Measures :
  1. Part A: Determine the maximum tolerated dose (MTD) of ASN007 [ Time Frame: First 21 days ]
    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

  2. 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. [ Time Frame: First 6 months ]
    This is the primary endpoint for Part B.


Secondary Outcome Measures :
  1. Calculate the pharmacokinetic area under the plasma concentration (AUC) of ASN007 [ Time Frame: First 21 days ]
    Calculate the amount of ASN007 in the bloodstream

  2. Calculate the maximum plasma concentration (Cmax) at steady state. [ Time Frame: First 21 days ]
    Calculate the maximum amount of ASN007 in the bloodstream

  3. Calculate the terminal elimination rate (T 1/2). [ Time Frame: First 21 days ]
    Calculate how fast ASN007 leaves the body


Other Outcome Measures:
  1. To evaluate the change from baseline in the intensity of phosphorylated ribosomal S6 kinase (RSK) found in tumor biopsies. [ Time Frame: Through the study, average 6 months ]
    Evaluate the effect of ASN007 on biomarkers

  2. Evaluate the change from baseline in the amount of circulating tumor DNA [ Time Frame: Every 8 weeks for the first 24 weeks, then every 12 weeks for up to 1 year ]
    Evaluate the effect of ASN007 on biomarkers



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415126


Contacts
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Contact: Study Manager, PhD 908-698-0988 Dana.kessler@asanabio.com
Contact: Sanjeeva Reddy, PhD 908-698-0926

Locations
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United States, Florida
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Zeynep Eroglu, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Ryan Sullivan, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Filip Janku, M.D.         
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Drew Rasco, M.D.         
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78240
Principal Investigator: Anthony Tolcher, M.D         
Sponsors and Collaborators
Asana BioSciences
Investigators
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Study Director: Medical Monitor Asana BioSciences

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Responsible Party: Asana BioSciences
ClinicalTrials.gov Identifier: NCT03415126     History of Changes
Other Study ID Numbers: ASN007-101
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asana BioSciences:
KRAS mutant
NRAS mutant
BRAF mutant
HRAS mutant
ERK 1/2 inhibitor
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Neoplasm Metastasis
Pancreatic Neoplasms
Colonic Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms by Histologic Type
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases