Advanced Solid TumorPhase 1NCT05791474
ATI-2231 in Advanced Solid Tumor Malignancies
A Phase 1 study testing ATI-2231 in people with Advanced Solid Tumor and Advanced Solid Tumor Malignancies, run by Washington University School of Medicine.
Trial summary
The purpose of this first-in-human study is to test ATI-2231 in advanced solid tumor malignancies with the goal of establishing the recommended Phase II dose of ATI-2231. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Advanced Solid Tumor Malignancies
- What is being tested?
- ATI-2231
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to 30 Jun 2025
- 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
- Biopsy-proven advanced solid tumor malignancy including head and neck cancer, non-small cell lung cancer, gastrointestinal adenocarcinoma, pancreatic adenocarcinoma, prostate cancer, bladder cancer, and breast cancer.
- Eligible patients must have an advanced solid malignancy above, for which standard curative or palliative therapies do not exist or are no longer effective.
- Measurable or non-measurable but evaluable disease by RECIST v 1.1.
- Patients must have archival tissue sample available from prior metastatic biopsy. If no tissue is available, patient may still be able to enroll with PI approval.
- At least 18 years of age.
- ECOG performance status ≤ 2
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- Life expectancy of at least 12 weeks.
- Adequate bone marrow and organ function as defined below:
- Leukocytes ≥ 3 K/cumm
- Absolute neutrophil count (ANC) ≥ 1.5 K/cumm
- Platelets ≥ 100 K/cumm
- Total bilirubin ≤ 1.5 x IULN (unless patient has known Gilberts disease)
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Creatinine clearance > 60 mL/min by Cockcroft-Gault
- The effects of ATI-2231on the developing human fetus are unknown. For this reason, women of childbearing potential and men who are heterosexually active must agree to use adequate contraception as specified in the protocol. Contraception should continue for 1 month (for women) or 3 months (for men) after the end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Who cannot join
- Patients may not have received the following investigational or SOC therapies within the below specified time frames prior to C1D1:
- Denosumab or bisphosphonates within 4 weeks
- Radiation therapy within 1 week
- Systemic chemotherapy, including antibody drug conjugates with chemotherapy payload, within 3 weeks.
- Immunotherapy within 3 weeks
- Oral chemotherapy or molecularly targeted therapy within 5 half-lives of the agent.
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- Endocrine therapies do not have a required washout and may be continued until C1D1.
- Untreated brain metastases. Patients with treated brain metastases are eligible if they show no evidence of progression and are off steroids or on stable/decreasing steroid dose.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ATI-2231.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Patients with known HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
- Screening resting QTcF above 460 ms (average of triplicate).
About this study
Official title: A Phase Ia Trial of ATI-2231 in Advanced Solid Tumor Malignancies
The purpose of this first-in-human study is to test ATI-2231 in advanced solid tumor malignancies with the goal of establishing the recommended Phase II dose of ATI-2231.
- Being tested
- ATI-2231
- Keywords
- MK2 inhibitor, ATI-2231
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-2231Drug
Provided by Aclaris Therapeutics, Inc.
| Study group | Role | What they receive |
|---|---|---|
| ATI-2231 monotherapy dose escalation | Experimental | * Patients will receive single agent ATI-2231 at assigned dose levels (n=3-6 per dose level). Starting dose of 20 mg by mouth twice per day.
* Each cycle is 21 days Receives: Drug: ATI-2231 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing adverse events
-Graded per CTCAE v. 5.0
Measured: From baseline through 30 days after end of treatment (estimated to be 7 months)
Secondary outcomes (17)
Changes in ATI-2231 pharmacokinetics (PK) as measured by time to peak drug concentration (Tmax)
Measured: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by elimination rate constant
Measured: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by apparent volume of distribution
Measured: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by apparent clearance
Measured: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by peak concentration (Cmax)
Measured: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by half-life (T1/2)
Measured: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by area under the curve (AUC0-24h)
Measured: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, and 24 hours post dose cycle 1 (estimated to be 1 day)
Changes in ATI-2231 pharmacokinetics (PK) as measured by area under the curve (AUC0-infinity)
Measured: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by area under the curve (AUC0-t)
Measured: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by peak concentration (Cmax)
Measured: Pre-dose cycle 2 day 1 (each cycle is 21 days), 1 hour, 2 hours, 4 hours, 6 hours, and 10 hours post dose cycle 2 day 1 (estimated to be 10 hours)
Changes in ATI-2231 pharmacokinetics (PK) as measured by trough concentration
Measured: Pre-dose cycle 2 day 1 (each cycle is 21 days), 1 hour, 2 hours, 4 hours, 6 hours, and 10 hours post dose cycle 2 day 1 (estimated to be 10 hours)
Changes in ATI-2231 pharmacokinetics (PK) as measured by area under the curve (AUC0-t)
Measured: Pre-dose cycle 2 day 1 (each cycle is 21 days), 1 hour, 2 hours, 4 hours, 6 hours, and 10 hours post dose cycle 2 day 1 (estimated to be 10 hours)
Changes in ATI-2231 pharmacokinetics (PK) as measured by time to peak drug concentration (Tmax)
Measured: Pre-dose cycle 2 day 1 (each cycle is 21 days), 1 hour, 2 hours, 4 hours, 6 hours, and 10 hours post dose cycle 2 day 1 (estimated to be 10 hours)
ATI-2231 pharmacokinetics (PK) as measured by trough concentration
Measured: Cycle 3 day 1 (each cycle is 21 days)
ATI-2231 pharmacokinetics (PK) as measured by trough concentration
Measured: Cycle 4 day 1 (each cycle is 21 days)
ATI-2231 pharmacokinetics (PK) as measured by trough concentration
Measured: Cycle 5 day 1 (each cycle is 21 days)
ATI-2231 pharmacokinetics (PK) as measured by trough concentration
Measured: Cycle 6 day 1 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start15 Nov 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Aclaris Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Cynthia X Ma, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791474
- Sponsor's protocol ID
- 202306048
- Status last verified
- Nov 2023
- First submitted
- 31 Jan 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data may be shared upon request with other non-commercial researchers and the request will be reviewed by the study team after the publication.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Trial of ATI-2231 in Advanced Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT05791474
- Acronym / sponsor ID
- 202306048
- Keywords
- MK2 inhibitor, ATI-2231
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Aclaris Therapeutics, Inc.
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Mar 2023 (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.
The purpose of this first-in-human study is to test ATI-2231 in advanced solid tumor malignancies with the goal of establishing the recommended Phase II dose of ATI-2231.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATI-2231 monotherapy dose escalation | Experimental | Drug: ATI-2231* Patients will receive single agent ATI-2231 at assigned dose levels (n=3-6 per dose level). Starting dose of 20 mg by mouth twice per day. * Each cycle is 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Biopsy-proven advanced solid tumor malignancy including head and neck cancer, non-small cell lung cancer, gastrointestinal adenocarcinoma, pancreatic adenocarcinoma, prostate cancer, bladder cancer, and breast cancer.
- Eligible patients must have an advanced solid malignancy above, for which standard curative or palliative therapies do not exist or are no longer effective.
- Measurable or non-measurable but evaluable disease by RECIST v 1.1.
- Patients must have archival tissue sample available from prior metastatic biopsy. If no tissue is available, patient may still be able to enroll with PI approval.
- At least 18 years of age.
Key exclusion criteria (13 listed)
- Patients may not have received the following investigational or SOC therapies within the below specified time frames prior to C1D1:
- Untreated brain metastases. Patients with treated brain metastases are eligible if they show no evidence of progression and are off steroids or on stable/decreasing steroid dose.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ATI-2231.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
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 |
|---|---|---|
| ATI-2231Provided by Aclaris Therapeutics, Inc. | Drug | ATI-2231 monotherapy dose escalation |
Primary outcome
Number of participants experiencing adverse events
Time frame: From baseline through 30 days after end of treatment (estimated to be 7 months)
-Graded per CTCAE v. 5.0
17 secondary outcomes
Changes in ATI-2231 pharmacokinetics (PK) as measured by time to peak drug concentration (Tmax)
Time frame: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by elimination rate constant
Time frame: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by apparent volume of distribution
Time frame: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by apparent clearance
Time frame: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by peak concentration (Cmax)
Time frame: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 day 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by half-life (T1/2)
Time frame: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by area under the curve (AUC0-24h)
Time frame: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, and 24 hours post dose cycle 1 (estimated to be 1 day)
Changes in ATI-2231 pharmacokinetics (PK) as measured by area under the curve (AUC0-infinity)
Time frame: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by area under the curve (AUC0-t)
Time frame: Pre-dose cycle 1 day 1, 1 hour, 2 hours, 4 hours, 6 hours, 10 hours, 24 hours, 30 hours, and 48 hours post dose cycle 1 (estimated to be 2 days)
Changes in ATI-2231 pharmacokinetics (PK) as measured by peak concentration (Cmax)
Time frame: Pre-dose cycle 2 day 1 (each cycle is 21 days), 1 hour, 2 hours, 4 hours, 6 hours, and 10 hours post dose cycle 2 day 1 (estimated to be 10 hours)
Changes in ATI-2231 pharmacokinetics (PK) as measured by trough concentration
Time frame: Pre-dose cycle 2 day 1 (each cycle is 21 days), 1 hour, 2 hours, 4 hours, 6 hours, and 10 hours post dose cycle 2 day 1 (estimated to be 10 hours)
Changes in ATI-2231 pharmacokinetics (PK) as measured by area under the curve (AUC0-t)
Time frame: Pre-dose cycle 2 day 1 (each cycle is 21 days), 1 hour, 2 hours, 4 hours, 6 hours, and 10 hours post dose cycle 2 day 1 (estimated to be 10 hours)
Changes in ATI-2231 pharmacokinetics (PK) as measured by time to peak drug concentration (Tmax)
Time frame: Pre-dose cycle 2 day 1 (each cycle is 21 days), 1 hour, 2 hours, 4 hours, 6 hours, and 10 hours post dose cycle 2 day 1 (estimated to be 10 hours)
ATI-2231 pharmacokinetics (PK) as measured by trough concentration
Time frame: Cycle 3 day 1 (each cycle is 21 days)
ATI-2231 pharmacokinetics (PK) as measured by trough concentration
Time frame: Cycle 4 day 1 (each cycle is 21 days)
ATI-2231 pharmacokinetics (PK) as measured by trough concentration
Time frame: Cycle 5 day 1 (each cycle is 21 days)
ATI-2231 pharmacokinetics (PK) as measured by trough concentration
Time frame: Cycle 6 day 1 (each cycle is 21 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual patient data may be shared upon request with other non-commercial researchers and the request will be reviewed by the study team after the publication.
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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.
Cynthia X Ma, M.D., Ph.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATI-2231 in people with Advanced Solid Tumor and Advanced Solid Tumor Malignancies, run by Washington University School of Medicine.
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 13 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: withdrawn, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of participants experiencing adverse events (time frame: From baseline through 30 days after end of treatment (estimated to be 7 months)). 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 29 Nov 2023.