A Study Of ASN007 In Patients With Advanced Solid Tumors

Study Overview

A Study of ASN007 in Patients With Advanced Solid Tumors

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.

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

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

ASN007-101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-01-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-07-07
First Submitted that Met QC Criteria 2018-01-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-07-09
First Posted (ACTUAL) 2018-01-30	Results First Posted N/A	Last Verified 2020-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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	Measure Description	Time Frame
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
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 Outcome Measures	Measure Description	Time Frame
Calculate the pharmacokinetic area under the plasma concentration (AUC) of ASN007	Calculate the amount of ASN007 in the bloodstream	First 21 days
Calculate the maximum plasma concentration (Cmax) at steady state.	Calculate the maximum amount of ASN007 in the bloodstream	First 21 days
Calculate the terminal elimination rate (T 1/2).	Calculate how fast ASN007 leaves the body	First 21 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Medical Monitor, Asana BioSciences

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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