Study of ASN004 in Patients With Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Carcinoma Breast
- Breast Adenocarcinoma
- Breast Cancer
- Non Small Cell Lung Cancer Recurrent
- Colon Neoplasm
- Non -Small Cell Lung Cancer
- Non-Small Cell Squamous Lung Carcinoma
- Colorectal Cancer Metastatic
- Colorectal Adenocarcinoma
- Breast Cancer Invasive
- Breast Cancer Metastatic
- Breast Cancer Recurrent
- Ovarian Neoplasm
- Non-Small Cell Adenocarcinoma
- Ovarian Cancer Recurrent
- Breast Neoplasms
- Carcinoma Colon
- Colorectal Neoplasms
- Colorectal (Colon or Rectal) Cancer
- Carcinoma Ovary
- Ovarian Cancer
- Colorectal Carcinoma
- Non Small Cell Lung Cancer Metastatic
- Carcinoma Non-small-cell Lung
- Carcinoma, Ovarian Epithelial
- Non-small Cell Carcinoma
- Colon Cancer
- Colorectal Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: Escalating doses of ASN004Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04410224
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Monitor Asana BioSciences
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