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CancerPhase 1NCT03415126

A Study of ASN007 in Patients With Advanced Solid Tumors

A Phase 1 study testing ASN007: ascending doses and ASN007 RD in people with Cancer and Malignancy, run by Asana BioSciences at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Malignancy, Neoplasia
What is being tested?
ASN007: ascending doses and ASN007 RD
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
5 sitesUnited States
Study dates
19 Jan 2018to 30 Jun 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

  • NEXT Oncology

    San Antonio, Texas, 78240

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Dose-Finding 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.

Read the 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

Being tested
ASN007: ascending doses, ASN007 RD
Keywords
KRAS mutant, NRAS mutant, BRAF mutant, HRAS mutant, ERK 1/2 inhibitor
Medical subject headings
Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Melanoma, Lung Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASN007: ascending dosesDrug

    Oral drug for the treatment of advanced solid tumors

  • ASN007 RDDrug

    Oral drug for the treatment of advanced solid tumors

Study groups in NCT03415126
Study groupRoleWhat they receive
ASN007 ascending dosesExperimentalPatients will receive escalating doses of ASN007 to identify the best dose.
Receives: Drug: ASN007: ascending doses
ASN007 RD: KRAS mutant MelanomaExperimentalPatients with BRAF mutant metastatic melanoma will receive the recommended dose from Part A.
Receives: Drug: ASN007 RD
ASN007 RD: NRAS mutant MelanomaExperimentalPatients with NRAS and HRAS mutant solid tumors will receive the recommended dose from Part A.
Receives: Drug: ASN007 RD
ASN007 RD: KRAS mutant metastatic CRCExperimentalPatients with KRAS mutant CRC will receive the recommended dose from Part A
Receives: Drug: ASN007 RD
ASN007 RD: KRAS mutant NSCLCExperimentalPatients with KRAS mutant NSCLC will receive the recommended dose from Part A
Receives: Drug: ASN007 RD
ASN007 RD: Metastatic Pancreatic CancerExperimentalPatients with pancreatic adenocarcinoma will receive the recommended dose from Part A
Receives: Drug: ASN007 RD
ASN007 RD: MEK, All BRAF, BRAF-fusion cancersExperimentalPatients with solid tumors will receive the recommended dose from Part A
Receives: Drug: ASN007 RD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: First 21 days

  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.

    This is the primary endpoint for Part B.

    Measured: First 6 months

Secondary outcomes (3)

  1. Calculate the pharmacokinetic area under the plasma concentration (AUC) of ASN007

    Calculate the amount of ASN007 in the bloodstream

    Measured: First 21 days

  2. Calculate the maximum plasma concentration (Cmax) at steady state.

    Calculate the maximum amount of ASN007 in the bloodstream

    Measured: First 21 days

  3. Calculate the terminal elimination rate (T 1/2).

    Calculate how fast ASN007 leaves the body

    Measured: First 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2018
  2. Study start19 Jan 2018
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03415126
Sponsor's protocol ID
ASN007-101
Status last verified
Jul 2020
First submitted
15 Jan 2018
Last updated
9 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASN007: ascending doses and ASN007 RD in people with Cancer and Malignancy, run by Asana BioSciences at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Determine the maximum tolerated dose (MTD) of ASN007 (time frame: First 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03415126.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.

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