A Study of ASN007 in Patients With Advanced Solid Tumors

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedASN007: ascending doses and ASN007 RD

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 9, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Asana BioSciences

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Asana BioSciences
Interventions being studied: Drug: ASN007: ascending doses; Drug: ASN007 RD

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

H. Lee Moffitt Cancer CenterTampa, Florida
Massachusetts General HospitalBoston, Massachusetts
MD Anderson Cancer CenterHouston, Texas
South Texas Accelerated Research TherapeuticsSan Antonio, Texas
NEXT OncologySan Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 9, 2020. Always confirm current availability with the study team.

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