Clinical Trial - NCT03415126

A Study of ASN007 in Patients With Advanced Solid Tumors

Recruiting

Sponsor: Asana BioSciences

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03415126

Protocol Info

Short Description: Phase I of ASN007 in ASTs
Long Description: A Phase 1, Open-Label, Dose-Finding Study of ASN007 in Patients with Advanced Solid Tumors
MGH Status: Open
Sponsor: Asana BioSciences
Disease Program: Phase I

Next Steps


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Purpose

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 Title Intervention 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 ASN007: ascending doses ASN007 RD Phase 1
Study Type Interventional
Official Title A Phase 1, Open-Label, Dose-Finding Study Of ASN007 In Patients With Advanced Solid Tumors

Primary Outcome Measures

Part A: Determine the maximum tolerated dose (MTD) of ASN007 [Time Frame: First 21 days] [Designated as safety issue: ]

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] [Designated as safety issue: ]


Secondary Outcome Measures

Calculate the pharmacokinetic area under the plasma concentration (AUC) of ASN007 [Time Frame: First 21 days] [Designated as safety issue: ]

Calculate the maximum plasma concentration (Cmax) at steady state. [Time Frame: First 21 days] [Designated as safety issue: ]

Calculate the terminal elimination rate (T 1/2). [Time Frame: First 21 days] [Designated as safety issue: ]

Estimated Enrollment: 110
Study Start Date: January 2018
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2020
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.

Experimental:ASN007 RD: KRAS mutant metastatic CRC

Patients with KRAS mutant CRC will receive the recommended dose from Part A

Experimental:ASN007 RD: KRAS mutant NSCLC

Patients with KRAS mutant NSCLC will receive the recommended dose from Part A

Experimental:ASN007 RD: Metastatic Pancreatic Cancer

Patients with pancreatic adenocarcinoma will receive the recommended dose from Part A

Experimental:ASN007 RD: MEK, All BRAF, BRAF-fusion cancers

Patients with solid tumors will receive the recommended dose from Part A

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03415126

Locations

  • United States, Florida
    • H. Lee Moffitt Cancer Center Tampa, Florida, United States, 33612
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • START - Grand Rapids Grand Rapids, Michigan, United States, 49546
  • United States, Texas
    • MD Anderson Cancer Center Houston, Texas, United States, 77030
    • South Texas Accelerated Research Therapeutics San Antonio, Texas, United States, 78229
    • NEXT Oncology San Antonio, Texas, United States, 78240

Sponsors and Collaborators

Asana BioSciences

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03415126
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Asana BioSciences:

KRAS mutant

NRAS mutant

BRAF mutant

HRAS mutant

ERK 1/2 inhibitor

Additional relevant MeSH terms:

Lung Neoplasms

Neoplasms

Carcinoma, Non-Small-Cell Lung

Adenocarcinoma

Neoplasm Metastasis

Pancreatic Neoplasms

Colonic Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on July 18, 2019