- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05791474
ATI-2231 in Advanced Solid Tumor Malignancies
November 28, 2023 updated by: Washington University School of Medicine
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cynthia X Ma, M.D, Ph.D.
- Phone Number: 314-362-8903
- Email: cynthiaxma@wustl.edu
Study Contact Backup
- Name: Katherine Clifton, M.D.
- Phone Number: 314-273-3712
- Email: k.clifton@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
Contact:
- Katherine Clifton, M.D.
- Phone Number: 314-273-3712
- Email: k.clifton@wustl.edu
-
Contact:
- Cynthia X Ma, M.D., Ph.D.
- Phone Number: 314-362-8903
- Email: cynthiaxma@wustl.edu
-
Principal Investigator:
- Cynthia X Ma, M.D., Ph.D.
-
Sub-Investigator:
- Sheila Stewart, Ph.D.
-
Sub-Investigator:
- Roberto Civitelli, M.D.
-
Sub-Investigator:
- Stefanie Geisler, M.D.
-
Sub-Investigator:
- Jingqin (Rosy) Luo, Ph.D.
-
Sub-Investigator:
- Katherine Clifton, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
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.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ATI-2231 monotherapy dose escalation
|
Provided by Aclaris Therapeutics, Inc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From baseline through 30 days after end of treatment (estimated to be 7 months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
Cycle 6 day 1 (each cycle is 21 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Cynthia X Ma, M.D., Ph.D., Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2023
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
January 31, 2023
First Submitted That Met QC Criteria
March 16, 2023
First Posted (Actual)
March 30, 2023
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202306048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
After the publication
IPD Sharing Access Criteria
Please email cynthiaxma@wustl.edu
for requests.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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