Study of ASN004 in Patients With Advanced Solid Tumors (ASN004)
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|ClinicalTrials.gov Identifier: NCT04410224|
Recruitment Status : Not yet recruiting
First Posted : June 1, 2020
Last Update Posted : June 2, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: ASN004||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Escalating doses of ASN004|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||September 19, 2020|
|Estimated Primary Completion Date :||September 19, 2021|
|Estimated Study Completion Date :||December 30, 2021|
Experimental: ASN004 ascending doses
Patients will receive escalating doses of ASN004 to identify the best dose for further study.
ASN004 is an antibody-drug conjugate for the treatment of advanced or metastatic solid tumors.
- 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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410224
|Contact: Study Manageremail@example.com|
|Contact: Backup Contactfirstname.lastname@example.org|
|Study Director:||Medical Monitor||Asana BioSciences|