Study of ASN004 in Patients With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asana BioSciences

Criteria

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.