A Study of ASN007 in Patients With Advanced Solid Tumors

NCT03415126 | Completed Phase 1 FDA Drug

• 1 other identifier: ASN007-101
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

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

  First 21 days

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

  First 21 days

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

  First 21 days

Other Outcomes (2)

• To evaluate the change from baseline in the intensity of phosphorylated ribosomal S6 kinase (RSK) found in tumor biopsies.

  Through the study, average 6 months

• Evaluate the change from baseline in the amount of circulating tumor DNA

  Every 8 weeks for the first 24 weeks, then every 12 weeks for up to 1 year

Study Arms (7)

ASN007 ascending doses

EXPERIMENTAL

Patients will receive escalating doses of ASN007 to identify the best dose.

Drug: ASN007: ascending doses

ASN007 RD: KRAS mutant Melanoma

EXPERIMENTAL

Patients with BRAF mutant metastatic melanoma will receive the recommended dose from Part A.

Drug: ASN007 RD

ASN007 RD: NRAS mutant Melanoma

EXPERIMENTAL

Patients with NRAS and HRAS mutant solid tumors will receive the recommended dose from Part A.

Drug: ASN007 RD

ASN007 RD: KRAS mutant metastatic CRC

EXPERIMENTAL

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

Drug: ASN007 RD

ASN007 RD: KRAS mutant NSCLC

EXPERIMENTAL

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

Drug: ASN007 RD

ASN007 RD: Metastatic Pancreatic Cancer

EXPERIMENTAL

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

Drug: ASN007 RD

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

EXPERIMENTAL

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

Drug: ASN007 RD

Interventions

ASN007: ascending doses DRUG

Oral drug for the treatment of advanced solid tumors

ASN007 ascending doses

ASN007 RD DRUG

Oral drug for the treatment of advanced solid tumors

ASN007 RD: KRAS mutant Melanoma; ASN007 RD: KRAS mutant NSCLC; ASN007 RD: KRAS mutant metastatic CRC; ASN007 RD: MEK, All BRAF, BRAF-fusion cancers; ASN007 RD: Metastatic Pancreatic Cancer; ASN007 RD: NRAS mutant Melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asana BioSciences: lead

Study Sites (5)

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

NEXT Oncology

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Melanoma; Lung Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Medical Monitor

  Asana BioSciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 30, 2018
• Study Start: January 19, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)