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History of Changes for Study: NCT03415126
A Study of ASN007 in Patients With Advanced Solid Tumors
Latest version (submitted July 7, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 29, 2018 None (earliest Version on record)
2 May 18, 2018 Study Status and Outcome Measures
3 July 9, 2018 Contacts/Locations and Study Status
4 October 1, 2018 Contacts/Locations and Study Status
5 November 30, 2018 Contacts/Locations and Study Status
6 February 12, 2019 Arms and Interventions, Study Status, Contacts/Locations, Outcome Measures and Study Description
7 September 3, 2019 Study Status and Contacts/Locations
8 December 6, 2019 Recruitment Status, Contacts/Locations, Study Status and Study Design
9 July 7, 2020 Recruitment Status and Study Status
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Study NCT03415126
Submitted Date:  January 29, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: ASN007-101
Brief Title: A Study of ASN007 in Patients With Advanced Solid Tumors
Official Title: A Phase 1, Open-Label, Dose-Finding Study Of ASN007 In Patients With Advanced Solid Tumors
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2018
Overall Status: Recruiting
Study Start: January 19, 2018
Primary Completion: May 2020 [Anticipated]
Study Completion: May 2020 [Anticipated]
First Submitted: January 15, 2018
First Submitted that
Met QC Criteria:
January 29, 2018
First Posted: January 30, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
January 29, 2018
Last Update Posted: January 30, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Asana BioSciences
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
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.

Open or close this module Conditions
Conditions: 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
Keywords: KRAS mutant
NRAS mutant
BRAF mutant
HRAS mutant
ERK 1/2 inhibitor
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 6
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 110 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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 ASN002 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. To evaluate the change from baseline in the intensity of Ribosomal S6 Kinase (RSK) found in circulating tumor cells.
[ Time Frame: Through the study, average 6 months ]

Evaluate the effect of ASN007 on biomarkers
3. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Study Manager
Telephone: 908-698-4973
Email: penny.bristow@asanabio.com
Central Contact Backup: Study Director
Telephone: 908-332-9119
Email: sarper.toker@asanabio.com
Study Officials: Medical Director
Study Director
Asana BioSciences
Locations: United States, Michigan
Cancer & Hematology Centers of Western Michigan
[Recruiting]
Grand Rapids, Michigan, United States, 49546
United States, Texas
South Texas Accelerated Research Therapeutics
[Recruiting]
San Antonio, Texas, United States, 78229
Contact:Principal Investigator: Drew Rasco, M.D.
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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