Study of ASN004 in Patients With Advanced Solid Tumors (ASN004)
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- STATUS
- Recruiting
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- End date
- Mar 12, 2024
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- participants needed
- 43
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- sponsor
- Asana BioSciences
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.
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.
Details
| Condition | 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 |
|---|---|
| Treatment | ASN004 |
| Clinical Study Identifier | NCT04410224 |
| Sponsor | Asana BioSciences |
| Last Modified on | 10 July 2022 |
Eligibility
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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