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Study of ASN004 in Patients With Advanced Solid Tumors (ASN004)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04410224
Recruitment Status : Not yet recruiting
First Posted : June 1, 2020
Last Update Posted : June 2, 2020
Information provided by (Responsible Party):
Asana BioSciences

Tracking Information
First Submitted Date  ICMJE May 27, 2020
First Posted Date  ICMJE June 1, 2020
Last Update Posted Date June 2, 2020
Estimated Study Start Date  ICMJE September 19, 2020
Estimated Primary Completion Date September 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2020)
Determine the maximum tolerated dose of ASN004 [ Time Frame: first 21 days ]
The MTD will be determined by evaluating the number of subjects with treatment related adverse events (AEs) and DLTs.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2020)
  • Calculate the pharmacokinetic (PK) area under the plasma concentration of ASN004 [ Time Frame: First 63 days ]
    Calculate the amount of ASN004 in the bloodstream
  • Calculate the maximum plasma concentration at steady state [ Time Frame: First 63 days ]
    Calculate the maximum amount of ASN004 in the bloodstream
  • Calculate the terminal elimination rate of ASN004 [ Time Frame: First 63 days ]
    Calculate how fast ASN004 leaves the body
  • Change in the size of measurable tumor lesions [ Time Frame: up to 1 year ]
    Change from baseline in the sum of the longest dimension in millimeters or each measurable lesion
  • Change in the status of non-measurable tumor lesions [ Time Frame: Up to 1 year ]
    Number of subjects that have resolution on non-measurable tumor lesions
  • Appearance of new tumor lesions [ Time Frame: Up to 1 year ]
    Number of subjects with new lesions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 27, 2020)
Correlate 5T4 oncofetal protein (5T4) expression and clinical efficacy [ Time Frame: Up to 1 year ]
Number of patients with 5T4 expression that have a complete response, partial response or prolonged stable disease when receiving ASN004.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Study of ASN004 in Patients With Advanced Solid Tumors
Official Title  ICMJE An Open Label, Multicenter, Dose-Finding Clinical Phase 1 Study of ASN004 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy in Patients With Advanced Malignant Solid Tumors
Brief Summary

Participants in this study will receive ASN004 once every 3 weeks by intravenous infusion. The study will test various doses of ASN004 to find out the highest safe dose to test in future trials.

Eligible subjects will be sequentially enrolled in cohorts at escalated doses. There will be up to 43 evaluable patients in about seven dose levels with up to six subjects per dose level.

Detailed Description

Eligible patients will be sequentially enrolled sequentially in an accelerated titration design study. Initial dose cohorts will contain single patients and dose escalation of no more than 100%. After the observation of a dose limiting toxicity (DLT), or the second Grade 2 adverse event, or at dose level 4 (12 mg/m2), the study will switch to a 3+3 design with 3-6 patients per cohort. pharmacodynamics (PD) data.

Dose escalation decisions will be based on the review of clinical safety and pharmacokinetic (PD) and pharmacodynamics (PD) data, and agreed upon by the Sponsor and investigators.

The maximum tolerated dose (MTD) will have an estimated DLT rate of < 33%. Cohorts may be expanded at any dose level or at the MTD for further evaluation of safety, or PK parameters as required.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Intervention Model Description:
Escalating doses of ASN004
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Breast Neoplasms
  • Breast Adenocarcinoma
  • Breast Cancer Recurrent
  • Breast Cancer Metastatic
  • Breast Cancer Invasive
  • Non-small Cell Lung Cancer
  • Non-small Cell Carcinoma
  • Non-small Cell Lung Cancer Recurrent
  • Non-Small Cell Squamous Lung Carcinoma
  • Non-Small Cell Adenocarcinoma
  • Non-small Cell Lung Cancer Metastatic
  • Colorectal Cancer
  • Colorectal Neoplasms
  • Colorectal Carcinoma
  • Colorectal Adenocarcinoma
  • Colorectal Cancer Metastatic
  • Colorectal (Colon or Rectal) Cancer
  • Colon Cancer
  • Colon Neoplasm
  • Ovarian Cancer
  • Ovarian Neoplasm
  • Ovarian Cancer Recurrent
  • Carcinoma, Ovarian Epithelial
  • Carcinoma Ovary
  • Carcinoma Colon
  • Carcinoma Breast
  • Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE Drug: ASN004
ASN004 is an antibody-drug conjugate for the treatment of advanced or metastatic solid tumors.
Study Arms  ICMJE Experimental: ASN004 ascending doses
Patients will receive escalating doses of ASN004 to identify the best dose for further study.
Intervention: Drug: ASN004
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2020)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date September 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Provide written, voluntary informed consent prior to any study specific procedure.
  • Histologically confirmed diagnosis of advanced malignant solid tumor.
  • Any malignant solid tumor type that has been described to express 5T4 in the scientific literature or in house data reports, including non small cell lung cancer, colorectal cancer, breast cancer, and ovarian cancer.
  • Not more than 4 liver metastases larger than 2 cm and no liver metastases larger than 5 cm.
  • No evidence or possible risk for bile duct obstruction.
  • No primary diagnosis of hepatocellular carcinoma.
  • All patients must be willing to undergo tumor biopsy, or provide archived tumor tissue.
  • Evidence of progressive disease.
  • Minimum life expectancy of at least 3 months.
  • Failure of standard therapy or no standard therapy available.
  • Presence of at least 1 measurable target lesion prior therapy:
  • Patients must not have received more than 3 chemotherapy treatment regimens for metastatic disease setting.
  • Patients must have completed prior cytotoxic chemotherapy or immunotherapy treatments at least 3 weeks prior to first dose of study drug.
  • Completion of prior targeted anticancer treatments at least 2 weeks or 5 half lives prior to first dose of study drug treatment, whichever is longer.
  • Patients must have completely recovered (Grade 1 or less) from any AE related to prior anticancer therapy except alopecia, or Grade 1 peripheral neuropathy.
  • Completely recovered from any prior treatment related hepatic toxicities.
  • No history of intrahepatic administration of chemotherapy.
  • No history of transaminase elevation 1 grade higher than baseline during chemotherapy for liver metastases (eg, oxaliplatin).
  • No history of immune checkpoint inhibitor hepatotoxicity, including immune mediated hepatitis.
  • Adult male and female patients at least 18 years old with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Male or female patients of childbearing potential must agree to the use of medically-acceptable methods of contraception, or gamete donation.
  • Adequate organ function as defined in the protocol.
  • Patient is willing and able to comply with all protocol required visits and assessments.

Exclusion Criteria

  • Hematologic malignancies and lymphomas.
  • Solid tumors not expected to respond to microtubule inhibitors.
  • Known hypersensitivity to ASN004, its components, or its excipients.
  • Prior allergic reaction to recombinant human or murine proteins or known history of human anti human or anti murine antibody formation.
  • Known central nervous system (CNS) metastasis.
  • Known bleeding diathesis.
  • History of hepatic cirrhosis, hepatic fibrosis, varices, or other clinically significant liver disease.
  • Use of hepatotoxic medications (allowance made for use of acetaminophen [Tylenol] for a limited time but at ≤ half of full daily dose - total daily dose < 2 g per day) during study participation and follow up.
  • History of or current alcohol use disorder (any severity)
  • History of or active hepatitis B or hepatitis C infection.
  • Major surgery within 30 days prior to the start of study medication
  • Serious infection within 14 days prior to the start of study medication.
  • Serious concurrent medical condition, such as: clinically significant history of cardiovascular disease such as congestive heart failure, uncontrolled hypertension, clinically significant ECG abnormalities, difficulty breathing at rest or requiring oxygen therapy, active pneumonitis or interstitial lung disease, or biliary obstruction, biliary blockage, and biliary stents.
  • Radiation therapy exceeding more than 5 Gray to the mediastinum/heart.
  • Patients with known history of left ventricular ejection fraction of < 50%.
  • Prior treatment with anthracyclines exceeding a cumulative dose of 400 mg/m2.
  • Receipt of any investigational treatment within 4 weeks prior to the start of study medication.
  • Any previous treatment with antibody-drug conjugate
  • Prior participation, ie, receipt of study medication, in this study.
  • Any condition that may impair the patient's ability to comply with study procedures or impact that ability to interpret study results.
  • Active and clinically significant bacterial, fungal, and viral infection such as immunodeficiency virus.
  • Female patients who are pregnant or breastfeeding or intend to become pregnant during their participation in the study or male patients who intend to father a child during their participation in the study.
  • History of another invasive malignancy that has not been in remission for at least 2 years. Exceptions to the 2 year limit include non melanoma skin cancer, ductal carcinoma in situ, and cervical cancer in situ.
  • Any medical history, laboratory, imaging, ECG, or other findings that, in the opinion of the Investigator, the Sponsor, or Medical Monitor, can indicate an unacceptable risk for the patient's participation in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Manager 908-698-0988
Contact: Backup Contact 908-698-0988
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04410224
Other Study ID Numbers  ICMJE ASN004-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Asana BioSciences
Study Sponsor  ICMJE Asana BioSciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Asana BioSciences
PRS Account Asana BioSciences
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP