A Phase I/II Study of AST-001 in Subjects With Advanced Solid Tumors

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Description

A first-in-human open-label, Phase I/II study to evaluate the safety, tolerability, MTD/RP2D, PK, and preliminary efficacy of AST-001 administered as a single agent.

Study Overview

Start Date
July 7, 2022
Completion Date
August 31, 2027
Enrollment
180
Date Posted
February 7, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Jinlin Cancer Hospital
Changchun, Jinlin 130000, China

Eligibility

Minimum Age (years)
18
Maximum Age (years)
70
Eligibility Criteria
phase I: dose escalation phase

Inclusion Criteria:

Patient has ability to understand the risks of the study and is willing to comply with the protocol and has signed a written informed consent.
Aged 18-70 years (inclusive), males and females.
Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative do not exist or are no longer effective.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Expected life expectancy ≥ 12 weeks
Recovered from toxicities of prior therapy to Grade 0 or 1
An adequate renal, liver and bone marrow function.

Exclusion Criteria:

History of another primary malignancy within 2 years prior to Day 1, except for adequately treated basaloma, in situ cancer, or other cancers whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the current study.
Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1.
Treatment with radiation therapy, chemotherapy, biotherapy, targeted therapies or hormones within 4 weeks prior to Day 1.
Receiving investigational therapy within 4 weeks prior to Day 1.
Concomitant use of repaglinide, medium/strong CYP2C8/CYP2B6/ CYP2C9 inhibitors/inducers.
Pleural effusion or ascites which need to be drained every other week or more frequently.
HBV infection and HBV-DNA ≥ 2,000 IU/mL
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
History of human immunodeficiency virus (HIV) infection or syphilis infection.

History of cardiac disease fits any of the following conditions:

NYHA III or IV CHF;
QTcF : male > 450ms,female > 470ms;
Myocardial infarction, bypass surgery, stent surgery within 6 months prior to Day 1;
Other cardiac disease that the investigator judged unsuitable for inclusion.
Females who are pregnant or breast-feeding
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Previously allergic to ethanol, polyoxyethylene (35) castor oil, N, N-dimethylacetamide.

Unwillingness or inability to comply with the study protocol for any reason

phase II: pancreatic cancer

Inclusion Criteria:

Patient has ability to understand the risks of the study and is willing to comply with the protocol and has signed a written informed consent.
Aged 18-70 years (inclusive), males and females.
Histologically or cytologically confirmed pancreatic cancer that is unresectable or cannot be controlled by local treatment and for which standard curative do not exist or are no longer effective.
At least one measurable lesion that meets RECIST 1.1 criteria.
Can provide pathological wax blocks or sections (including archived pathological wax blocks or sections) for AKR1C3 expression analysis and be confirmed that AKR1C3 expression is strongly positive.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Expected life expectancy ≥ 12 weeks
Recovered from toxicities of prior therapy to Grade 0 or 1
An adequate renal, liver and bone marrow function.

Exclusion Criteria:

History of another primary malignancy within 2 years prior to Day 1, except for adequately treated basaloma, in situ cancer, or other cancers whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the current study.
Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1.
Treatment with radiation therapy, chemotherapy, biotherapy, targeted therapies or hormones within 4 weeks prior to Day 1.
Receiving investigational therapy within 4 weeks prior to Day 1.
Concomitant use of repaglinide, medium/strong CYP2C8/CYP2B6/ CYP2C9 inhibitors/inducers.
Pleural effusion or ascites which need to be drained every other week or more frequently.
HBV infection and HBV-DNA ≥ 2,000 IU/mL
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
History of human immunodeficiency virus (HIV) infection or syphilis infection.

History of cardiac disease fits any of the following conditions:

NYHA III or IV CHF;
QTcF : male > 450ms,female > 470ms;
Myocardial infarction, bypass surgery, stent surgery within 6 months prior to Day 1;
Other cardiac disease that the investigator judged unsuitable for inclusion.
Females who are pregnant or breast-feeding
Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Previously allergic to ethanol, polyoxyethylene (35) castor oil, N, N-dimethylacetamide.
Unwillingness or inability to comply with the study protocol for any reason

Study Contact Info

Study Contact Name
Claire Hao
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06245330