Solid TumorPhase 1/2NCT06245330
A Phase I/II Study of AST-001 in Subjects With Advanced Solid Tumors
A Phase 1/2 study testing AST-001 in people with Solid Tumor and Pancreatic Cancer, run by Ascentawits Pharmaceuticals, Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor, Pancreatic Cancer
- What is being tested?
- AST-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2022to 31 Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- An adequate renal, liver and bone marrow function.
- 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.
Who cannot join
- 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.
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- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jinlin Cancer Hospital
Changchun, Jinlin, 130000
YING CHENG, PROFESSOR, 13943012851, jl.cheng@163.com
About this study
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Correlation With AKR1C3 Enzyme Expression of AST-001 in Subjects With Advanced Solid Tumors
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.
- Conditions
- Solid Tumor, Pancreatic Cancer
- Being tested
- AST-001
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-001Drug
liquid formulation for Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation phase | Experimental | AST-001 (5.0 mg/m^2 to 40.0 mg/m^2) will be administered by IV infusion on Days 1, 8 and 15 of each 28-day cycle to determine the MTD and RP2D with a BOIN design. Receives: Drug: AST-001 |
| phase II pancreatic cancer | Experimental | AST-001 (RP2D) will be administered by IV infusion on Days 1, 8 and 15 of each 28-day cycle Receives: Drug: AST-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Adverse events will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Adverse events will be noted as it occurs. Timeframe for measure begins after informed consent until 30 days after last dose of study drug.
Assess safety changes in electrocardiogram (ECG)
Resting 12-lead ECGs will be obtained from all subjects' pre-AST-001 infusion and within 30 minutes post-AST-001 infusion in order to assess any impact AST-001 may have on the QT interval as assessed by the Fridericia's Correction Formula (QTcF).
Measured: Day 1 of each cycle(there are 26 cycles; 28 days for each cycle)
Assess safety changes of body weight.
If during treatment a subject's body weight changes by >10%, the dose should be adjusted.
Measured: pre-AST-001 infusion of each cycle (there are 26 cycles; 28 days for each cycle)
Number of participants with dose limiting toxicities (DLTs)
A DLT is defined as the occurrence of Grade 3/4 adverse events within the first cycle (the first 28 days) of treatment that are considered by the investigator to be at least possibly related to AST-001.
Measured: Throughout Cycle 1 (28 days for each cycle)
Define the Recommended Phase 2 Dose (RP2D)
Determination of the MTD, based on the frequently of DLTs observed in Cycle 1 in subjects recruited to the Dose Escalation Phase.
Measured: Days 1, 8 and 15 of each cycle (all 26 cycles and there are 28 days for each cycle)
Pharmacokinetics (PK) - Time to maximum concentration (Tmax)
Tmax of AST-001 and AST-2660 will be computed for each subject where possible
Measured: Days 1 and 15 of Cycle 1 (first cycle of 26 cycles and there are 28 days for each cycle)
PK - Maximum peak plasma concentration (Cmax)
Cmax of AST-001 and AST-2660 will be computed for each subject where possible.
Measured: Days 1 and 15 of Cycle 1 (first cycle of 26 cycles and there are 28 days for each cycle)
PK - Area under the concentration-time curve (AUClast) PK - Area under the concentration-time curve (AUClast)
AUClast from Hour 0 through the last quantifiable concentration time (LQCT), where LQCT is the time at which the last sample with a quantifiable concentration was drawn
Measured: Days 1 and 15 of Cycle 1 (first cycle of 26 cycles and there are 28 days for each cycle)
PK - Half-life (T1/2)
T1/2 computed as ln (2)/Kel of AST-001 and AST-2660 will be computed for each subject where possible.
Measured: Days 1 and 15 of Cycle 1 (first cycle of 26 cycles and there are 28 days for each cycle)
Efficacy: Objective response rate(ORR)
ORR will be assessed as a primary outcome in phase II.
Measured: up to 26 cycles (there are 28 days for each cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start7 Jul 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentawits Pharmaceuticals, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Cheng, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245330
- Sponsor's protocol ID
- AT-001-001
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Correlation With AKR1C3 Enzyme Expression of AST-001 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06245330
- Acronym / sponsor ID
- AT-001-001
- Conditions
- Solid Tumor, Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ascentawits Pharmaceuticals, LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation phase | Experimental | Drug: AST-001AST-001 (5.0 mg/m^2 to 40.0 mg/m^2) will be administered by IV infusion on Days 1, 8 and 15 of each 28-day cycle to determine the MTD and RP2D with a BOIN design. |
| phase II pancreatic cancer | Experimental | Drug: AST-001AST-001 (RP2D) will be administered by IV infusion on Days 1, 8 and 15 of each 28-day cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (37 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AST-001liquid formulation for Intravenous infusion | Drug | Dose escalation phase, phase II pancreatic cancer |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: Adverse events will be noted as it occurs. Timeframe for measure begins after informed consent until 30 days after last dose of study drug.
Adverse events will be graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.
Assess safety changes in electrocardiogram (ECG)
Time frame: Day 1 of each cycle(there are 26 cycles; 28 days for each cycle)
Resting 12-lead ECGs will be obtained from all subjects' pre-AST-001 infusion and within 30 minutes post-AST-001 infusion in order to assess any impact AST-001 may have on the QT interval as assessed by the Fridericia's Correction Formula (QTcF).
Assess safety changes of body weight.
Time frame: pre-AST-001 infusion of each cycle (there are 26 cycles; 28 days for each cycle)
If during treatment a subject's body weight changes by >10%, the dose should be adjusted.
Number of participants with dose limiting toxicities (DLTs)
Time frame: Throughout Cycle 1 (28 days for each cycle)
A DLT is defined as the occurrence of Grade 3/4 adverse events within the first cycle (the first 28 days) of treatment that are considered by the investigator to be at least possibly related to AST-001.
Define the Recommended Phase 2 Dose (RP2D)
Time frame: Days 1, 8 and 15 of each cycle (all 26 cycles and there are 28 days for each cycle)
Determination of the MTD, based on the frequently of DLTs observed in Cycle 1 in subjects recruited to the Dose Escalation Phase.
Pharmacokinetics (PK) - Time to maximum concentration (Tmax)
Time frame: Days 1 and 15 of Cycle 1 (first cycle of 26 cycles and there are 28 days for each cycle)
Tmax of AST-001 and AST-2660 will be computed for each subject where possible
PK - Maximum peak plasma concentration (Cmax)
Time frame: Days 1 and 15 of Cycle 1 (first cycle of 26 cycles and there are 28 days for each cycle)
Cmax of AST-001 and AST-2660 will be computed for each subject where possible.
PK - Area under the concentration-time curve (AUClast) PK - Area under the concentration-time curve (AUClast)
Time frame: Days 1 and 15 of Cycle 1 (first cycle of 26 cycles and there are 28 days for each cycle)
AUClast from Hour 0 through the last quantifiable concentration time (LQCT), where LQCT is the time at which the last sample with a quantifiable concentration was drawn
PK - Half-life (T1/2)
Time frame: Days 1 and 15 of Cycle 1 (first cycle of 26 cycles and there are 28 days for each cycle)
T1/2 computed as ln (2)/Kel of AST-001 and AST-2660 will be computed for each subject where possible.
Efficacy: Objective response rate(ORR)
Time frame: up to 26 cycles (there are 28 days for each cycle)
ORR will be assessed as a primary outcome in phase II.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ying Cheng principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AST-001 in people with Solid Tumor and Pancreatic Cancer, run by Ascentawits Pharmaceuticals, Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Hao ((0086)13207649065, claire.hao@ascentawitspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: Adverse events will be noted as it occurs. Timeframe for measure begins after informed consent until 30 days after last dose of study drug.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.