About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Provide written, voluntary informed consent prior to any -study specific procedure.
2. Histologically confirmed diagnosis of advanced malignant solid tumor.
3. All patients must be willing to undergo tumor biopsy, preferably of the primary tumor, within 28 days prior to Cycle 1 Day 1. If the Investigator determines that the tumor is inaccessible for biopsy, archived tumor material collected within the last 12 months may be submitted.
4. Evidence of progressive disease.
5. Minimum life expectancy of at least 3 months, in the judgment of the Investigator.
6. Failure of standard therapy or no standard therapy available.
7. Presence of at least 1 measurable target lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 excluding previously irradiated lesions, bone metastasis, or pleural effusion as sole manifestations of disease.
8. Patient's most recent therapy must have been completed within the following limits prior to the first dose of study drug:
9. prior cytotoxic chemotherapy treatments at least 3 weeks prior to first dose of study drug.
10. Completion of prior targeted anticancer treatments at least 2 weeks or 5 -half-lives prior to first dose of study drug, whichever is longer.
11. Completion of prior immuno-oncology treatments at least 3 weeks prior to first dose of study drug.
12. Patients must have recovered from any AE related to prior anticancer therapy to Grade 1 or less except for alopecia.
13. Age of at least 18 years old.
14. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
15. A male patient must agree to use contraception as detailed in this protocol during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.
16. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies. i. Not a woman of childbearing potential (WOCBP) OR ii. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment.
17. Adequate organ function as determined by the following criteria:
18. Hemoglobin ≥ 9.0 g/dL.
19. Absolute neutrophil count ≥ 1.5 × 10^(9)/L.
20. Platelet count ≥ 100 × 10^(9)/L.
21. Serum creatinine ≤ 2 × upper limit of normal (ULN) AND calculated creatinine clearance of > 60 mL/min.
22. Aspartate aminotransferase (AST; serum glutamic oxaloacetic transaminase) and alanine aminotransferase (ALT; serum glutamic-pyruvic transaminase) ≤ 3× ULN (or ≤ 2.5 × ULN if liver metastases).
23. Total bilirubin ≤ 1.5 x ULN.
24. Albumin ≥ 2.5 g/dL.
25. Activated partial thromboplastin time, prothrombin time, and international normalized ratio within normal limits unless anticoagulated for VTE treatment/prophylaxis at stable dose.
26. Patient is willing and able to comply with all protocol required visits and assessments.

Exclusion criteria

1. Hematologic malignancies and lymphomas.
2. Known hypersensitivity to ASN004, its components, or its excipients.
3. Prior allergic reaction to recombinant human or murine proteins or known history of human anti-human or anti-murine antibody formation.
4. Known central nervous system (CNS) metastasis.
5. Known bleeding diathesis.
6. History of or active hepatitis B or hepatitis C infection.
7. Major surgery within 30 days prior to the start of study medication.
8. Infection requiring intravenous antibiotics within 14 days prior to the start of study medication.
9. Serious concurrent medical conditions, such as:
10. Clinically significant history of cardiovascular disease such as congestive heart failure New York Heart Association Class III or IV or uncontrolled hypertension at Screening.
11. 12-Lead electrocardiogram (ECG) abnormalities considered by the Investigator to be clinically significant including QTcF ≥ 450 milliseconds at Screening (abnormal ECG confirmed by repeat assessment).
12. Severe dyspnea at rest or requiring oxygen therapy.
13. Active pneumonitis or interstitial lung disease.
14. Biliary obstruction, biliary blockage, and biliary stents.
15. Radiation therapy exceeding more than 5 Gray to the mediastinum/heart.
16. Patients with known history of left ventricular ejection fraction of < 50%.
17. Receipt of any investigational treatment within 4 weeks prior to the start of study medication.
18. Any previous treatment with antibody drug conjugate (ADC).
19. Prior participation, i.e., receipt of study medication, in this study.
20. Any condition that may impair the patient's ability to comply with study procedures or impact that ability to interpret study results.
21. Active and clinically significant bacterial, fungal, and viral infection such as immunodeficiency virus.
22. 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.
23. 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.
24. Any medical history, laboratory, imaging, ECG, or other findings that, in the opinion of the Investigator, the Sponsor or Contract Research Organization (CRO) Medical Monitor, can indicate an unacceptable risk for the patient's participation in the study.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.