Solid TumorPhase 1ASN004NCT04410224
Study of ASN004 in Patients With Advanced Solid Tumors
A Phase 1 study testing ASN004 in people with Solid Tumor, run by Kirilys Therapeutics Inc. at 4 sites in United States.
Trial summary
Participants in this study will receive ASN004 once every 3 or 4 weeks by intravenous infusion. The ASN004 dosing schedule may be modified based on emerging data and Safety Review Committee decision. The study will test various doses of ASN004 to find out the highest safe dose to test in future trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- ASN004
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Apr 2022to 8 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written, voluntary informed consent prior to any -study specific procedure.
- Histologically confirmed diagnosis of advanced malignant solid tumor.
- All patients must agree to provide fresh or archival tumor tissue from the tumor lesion that has not been previously irradiated. Patients without archival tissue may only be enrolled if the patient consents to a screening biopsy and this procedure may be safely performed in the judgment of the Investigator.
- Evidence of progressive disease.
- For Dose Expansion patients, eligible tumor histologies will be limited to those malignancies known to have highest expression of 5T4 including colorectal, breast, ovarian, lung, liver, and renal carcinomas. A maximum of 3 prior cytotoxic chemotherapy regimens is permitted for advanced disease.
- Failure of standard therapy or no standard therapy available.
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- Presence of at least 1 measurable target lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 excluding previously irradiated lesions, bone metastasis, or pleural effusion as sole manifestations of disease. Dose escalation patients with evaluable (non-measurable) disease may be permitted to enroll with Medical Monitor approval.
- Age of at least 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- A male patient must agree to use contraception as detailed in this protocol during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.
- A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies.
- Not a woman of childbearing potential (WOCBP) OR ii. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment.
- Adequate organ function.
- Patients with Mandatory 5T4 Expression: Patients replacing a previously enrolled non-5T4 expressing patient must consent to and provide fresh or archival tumor tissue to the central pathology laboratory for 5T4 immunohistochemistry (IHC) testing. To be eligible, the patient's tumor must be confirmed by the central pathology laboratory to express 5T4 (H score of ≥ 10).
- Patient is willing and able to comply with all protocol required visits and assessments.
Who cannot join
- Hematologic malignancies and lymphomas.
- Patients with known brain metastases unless the patient has a single lesion or multiple lesions whose sum of the longest diameter is ≤ 1 cm AND who are asymptomatic.
- Serious concurrent medical conditions.
- Patients with known history of left ventricular ejection fraction of < 50%.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
NEXT Oncology
Austin, Texas, 78758
Next Oncology
Fairfax, Virginia, 22031
NEXT Oncology
San Antonio, Texas, 78240
About this study
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
Participants in this study will receive ASN004 once every 3 or 4 weeks by intravenous infusion. The ASN004 dosing schedule may be modified based on emerging data and Safety Review Committee decision. 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.
Read the detailed description
Eligible patients will be sequentially enrolled at escalating doses.
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.
- Conditions
- Solid Tumor
- Being tested
- ASN004
- Keywords
- antibody-drug conjugate, immunoconjugate, General Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASN004Drug
ASN004 is an antibody-drug conjugate for the treatment of advanced or metastatic solid tumors.
| Study group | Role | What they receive |
|---|---|---|
| ASN004 ascending doses | Experimental | Patients will receive escalating doses of ASN004 to identify the best dose for further study. Receives: Drug: ASN004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose of ASN004
The MTD will be determined by evaluating the number of subjects with treatment related adverse events (AEs) and DLTs.
Measured: first 21 days for patients administered ASN004 every 3 weeks, and first 28 days for patients administered ASN004 every 4 weeks
Secondary outcomes (6)
Calculate the pharmacokinetic (PK) area under the plasma concentration of ASN004
Calculate the amount of ASN004 in the bloodstream
Measured: First 63 days
Calculate the maximum plasma concentration at steady state
Calculate the maximum amount of ASN004 in the bloodstream
Measured: First 63 days
Calculate the terminal elimination rate of ASN004
Calculate how fast ASN004 leaves the body
Measured: First 63 days
Change in the size of measurable tumor lesions
Change from baseline in the sum of the longest dimension in millimeters or each measurable lesion
Measured: up to 1 year
Change in the status of non-measurable tumor lesions
Number of subjects that have resolution on non-measurable tumor lesions
Measured: Up to 1 year
Appearance of new tumor lesions
Number of subjects with new lesions
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start8 Apr 2022
- Primary completion8 May 2024
- Study completion8 May 2024
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Escalating doses of ASN004
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirilys Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alison L Hannah, MD, Study director, Kirilys Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410224
- Sponsor's protocol ID
- ASN004-101
- Acronym
- ASN004
- Status last verified
- Jul 2024
- First submitted
- 27 May 2020
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04410224
- Acronym / sponsor ID
- ASN004 / ASN004-101
- Conditions
- Solid Tumor
- Keywords
- antibody-drug conjugate, immunoconjugate, General Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Kirilys Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 1 Jun 2020 (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.
Participants in this study will receive ASN004 once every 3 or 4 weeks by intravenous infusion. The ASN004 dosing schedule may be modified based on emerging data and Safety Review Committee decision. 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.
Detailed description
Eligible patients will be sequentially enrolled at escalating doses.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Escalating doses of ASN004
| Arm | Type | Receives |
|---|---|---|
| ASN004 ascending doses | Experimental | Drug: ASN004Patients will receive escalating doses of ASN004 to identify the best dose for further study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provide written, voluntary informed consent prior to any -study specific procedure.
- Histologically confirmed diagnosis of advanced malignant solid tumor.
- All patients must agree to provide fresh or archival tumor tissue from the tumor lesion that has not been previously irradiated. Patients without archival tissue may only be enrolled if the patient consents to a screening biopsy and this procedure may be safely performed in the judgment of the Investigator.
- Evidence of progressive disease.
- For Dose Expansion patients, eligible tumor histologies will be limited to those malignancies known to have highest expression of 5T4 including colorectal, breast, ovarian, lung, liver, and renal carcinomas. A maximum of 3 prior cytotoxic chemotherapy regimens is permitted for advanced disease.
Key exclusion criteria (4 listed)
- Hematologic malignancies and lymphomas.
- Patients with known brain metastases unless the patient has a single lesion or multiple lesions whose sum of the longest diameter is ≤ 1 cm AND who are asymptomatic.
- Serious concurrent medical conditions.
- Patients with known history of left ventricular ejection fraction of < 50%.
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 |
|---|---|---|
| ASN004ASN004 is an antibody-drug conjugate for the treatment of advanced or metastatic solid tumors. | Drug | ASN004 ascending doses |
Primary outcome
Determine the maximum tolerated dose of ASN004
Time frame: first 21 days for patients administered ASN004 every 3 weeks, and first 28 days for patients administered ASN004 every 4 weeks
The MTD will be determined by evaluating the number of subjects with treatment related adverse events (AEs) and DLTs.
6 secondary outcomes
Calculate the pharmacokinetic (PK) area under the plasma concentration of ASN004
Time frame: First 63 days
Calculate the maximum plasma concentration at steady state
Time frame: First 63 days
Calculate the terminal elimination rate of ASN004
Time frame: First 63 days
Change in the size of measurable tumor lesions
Time frame: up to 1 year
Change in the status of non-measurable tumor lesions
Time frame: Up to 1 year
Appearance of new tumor lesions
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alison L Hannah, MD study director
Kirilys Therapeutics Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASN004 in people with Solid Tumor, run by Kirilys Therapeutics Inc. at 4 sites in United States.
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 15 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the maximum tolerated dose of ASN004 (time frame: first 21 days for patients administered ASN004 every 3 weeks, and first 28 days for patients administered ASN004 every 4 weeks). 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 10 Jul 2024.