Breast Cancer MetastaticPhase 1NCT07137871
Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy
A Phase 1 study testing Avasopasem in people with Breast Cancer Metastatic, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This study aims to evaluate the safety of avasopasem in combination with CDK 4/6 inhibitor and hormonal therapy in women with metastatic hormone receptor positive breast cancer, and to see if the addition of avasopasem improves the effectiveness of a CDK 4/6 inhibitor and hormonal therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Metastatic
- What is being tested?
- Avasopasem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2025to Oct 2028
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of HR+, HER2 negative metastatic breast cancer.
- Estrogen receptor (ER) and/or progesterone receptor (PR) expression positivity is defined as at least 10% of tumor cells nuclei positive by immunohistochemistry in the sample on testing.
- HER2 negative: defined as IHC staining of 0 or 1+. If HER2 overexpression is equivocal by IHC, defined as 2+, the tumor must be non-gene amplified by FISH (ratio <2 and HER2 copy number <4).
- Progression on treatment with a CDK 4/6 inhibitor and hormonal therapy in the metastatic setting
- The CDK 4/6 inhibitor must be ribociclib or abemaciclib. Patients on palbociclib are not eligible.
- Patient may have been on palbociclib previously but must have been stable on ribociclib or abemaciclib for at least three months prior to enrolling. In this case, the switch from palbociclib to either ribociclib or abemaciclib must have been of toxicity management and not progression of disease.
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- Hormonal therapy is defined as an aromatase inhibitor (anastrozole, letrozole, exemestane) or fulvestrant.
- Patients on tamoxifen are not eligible.
- Both men and pre/perimenopausal women must be on ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist.
- Patients must have measurable disease based on RECIST 1.1 criteria.
- Females of child-bearing potential (FOCBP) who engage in intercourse must agree to use adequate contraception (e.g., hormonal or an intrauterine device [IUD] or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 weeks following completion of therapy.
- NOTE: A FOCBP is any woman who meets the following criteria:
- Has not undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
- FOCBP must have a negative serum pregnancy test within 7 days prior to registration.
- Patients must be ≥ 18 years of age at the time of signing consent.
- Patients must have an estimated life expectancy of at least 12 weeks.
- Patients must exhibit an ECOG performance status of 0 or 1.
- Patients must have adequate organ and bone marrow function as defined below:
- Leukocytes (WBC) ≥ 3,000/mcL
- Absolute neutrophil count (ANC) ≥ 1000/mcL
- Hemoglobin (Hgb) ≥ 7 g/dL
- Platelets (PLT) ≥ 100,000/mcL
- Total bilirubin < 1.5 x Institutional upper limit of normal (ULN); ≤ 3.0 x ULN for patients with Gilbert's syndrome
- AST (SGOT)/ALT (SGPT) < 3 x institutional ULN, or < 5 x ULN if liver metastasis present
- Creatinine < 1.5 Institutional ULN
- Patients with treated brain metastases are eligible if follow-up brain imaging at least 6 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Patients must have sufficient samples available to meet Menarini Silicon Biosystems (MSB) specimen requirements.
- Patients with known history or current symptoms of cardiac disease, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have any systemic therapy in the metastatic setting except hormonal therapy in combination with a CDK 4/6 inhibitor. Previously palliative targeted radiation therapy is allowed. Bone targeting agents such as bisphosphonates and rank ligand inhibitors for metastatic breast cancer to the bone is also allowed prior and during this trial.
- Patients with untreated new or progressive brain metastases or leptomeningeal disease
- Use of concomitant nitrates and PDE5 inhibitors.
- Use of potent CYP3A4 inhibitors or inducers and not able to discontinue two weeks prior to enrolling onto the trial.
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints. Note: Patients with HIV or infectious hepatitis must exhibit well controlled disease with stable treatment regimen (where applicable) that in the opinion of the treating physician should not preclude them from participating in the study.
- Patients who are currently pregnant or breast feeding.
- Patients with a history of another invasive malignancy within 2 years of registration with the exception of local squamous cell or basal cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229
Kayla Chamberlin, RN, 210-450-1000, chamberlink@uthscsa.edu
Kate Lathrop, MD, 210-450-1000, lathrop@uthscsa.edu
About this study
Official title: Phase 1 Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy (CTMS# 24-0096)
This study aims to evaluate the safety of avasopasem in combination with CDK 4/6 inhibitor and hormonal therapy in women with metastatic hormone receptor positive breast cancer, and to see if the addition of avasopasem improves the effectiveness of a CDK 4/6 inhibitor and hormonal therapy.
Read the detailed description
This is a phase 1 non-randomized clinical trial of Avasopasem in patients with metastatic hormone receptor positive breast cancer with progression on first line therapy consisting of a CDK 4/6 inhibitor and hormonal therapy to determine the efficacy and safety of the addition of Avasopasem in patients with metastatic HR+ breast cancer with progression after first line treatment with hormonal therapy (an AI or fulvestrant) and a CDK 4/6 inhibitor (ribociclib or abemaciclib). Each treatment cycle will be 28 days and tumor assessment by imaging with CT scans of the chest, abdomen and pelvis will be performed every two cycles.
- Conditions
- Breast Cancer Metastatic
- Being tested
- Avasopasem
- Keywords
- Hormone receptor positive, HR+, HER2 negative metastatic breast cancer, Disease progression
- Medical subject headings
- Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvasopasemDrug
Also called GC4419
Avasopasem has also been shown to exhibit both antitumor effects as well as minimal toxicity. Participants are currently taking a CDK 4/6 inhibitor and hormonal therapy
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Hormone Receptor Positive Breast Cancer | Experimental | This study is investigating the addition of a novel agent, Avasopasem (or GC4419), in patients with hormonal receptor positive (HR+) metastatic breast cancer with progression while on treatment with a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor and an aromatase inhibitor. Receives: Drug: Avasopasem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Safety and Tolerability of Treatment
Determine the safety and tolerability of Avasopasem in combination with a CDK 4/6 inhibitor and hormonal therapy. Each cycle of treatment will be 28 days. Toxicity will be assessed starting on the first day of each 28-day treatment cycle, using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, and the incidence, nature, and severity of adverse events will be determined.All women who receive at least one dose of Avasopasem will be considered as evaluable for any toxicity and safety endpoints, as well as disease response. Patient reported outcome (PRO's) for adverse events (AE) will also be reported on day one of each cycle.
Measured: Day 1 through Day 28 (each cycle is 28 days, up to 4 months
Secondary outcomes (1)
Clinical Benefit Ratio (CBR) with addition of Avasopasem
Clinical benefit is defined as the percentage of patients with metastatic cancer who achieve as documented complete response, partial response, or stable disease following therapeutic intervention in this trial. A clinical benefit rate of 20% observed at 4 months (the time point for tumor assessment by Copy number alteration (CNA) and 18F-fluoroestradiol Positron Emission Tomography (FES-PET) will represent a clinically meaningful response rate with the addition of Avasopasem.
Measured: Day 1 through Day 28 (each cycle is 28 days, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start2 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Model description
- This is a single institution, non-randomized, phase 1 clinical trial
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Lathrop, The University of Texas Health Science Center at San Antonio
- Investigators
- Kate Lathrop, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137871
- Sponsor's protocol ID
- CTMS# 24-0096
- Other IDs
- STUDY00000816
- Status last verified
- Nov 2026
- First submitted
- 15 Aug 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy (CTMS# 24-0096)
- ClinicalTrials.gov ID
- NCT07137871
- Acronym / sponsor ID
- CTMS# 24-0096
- Conditions
- Breast Cancer Metastatic
- Keywords
- Hormone receptor positive, HR+, HER2 negative metastatic breast cancer, Disease progression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 22 Aug 2025 (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.
This study aims to evaluate the safety of avasopasem in combination with CDK 4/6 inhibitor and hormonal therapy in women with metastatic hormone receptor positive breast cancer, and to see if the addition of avasopasem improves the effectiveness of a CDK 4/6 inhibitor and hormonal therapy.
Detailed description
This is a phase 1 non-randomized clinical trial of Avasopasem in patients with metastatic hormone receptor positive breast cancer with progression on first line therapy consisting of a CDK 4/6 inhibitor and hormonal therapy to determine the efficacy and safety of the addition of Avasopasem in patients with metastatic HR+ breast cancer with progression after first line treatment with hormonal therapy (an AI or fulvestrant) and a CDK 4/6 inhibitor (ribociclib or abemaciclib). Each treatment cycle will be 28 days and tumor assessment by imaging with CT scans of the chest, abdomen and pelvis will be performed every two cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single institution, non-randomized, phase 1 clinical trial
| Arm | Type | Receives |
|---|---|---|
| Metastatic Hormone Receptor Positive Breast Cancer | Experimental | Drug: AvasopasemThis study is investigating the addition of a novel agent, Avasopasem (or GC4419), in patients with hormonal receptor positive (HR+) metastatic breast cancer with progression while on treatment with a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor and an aromatase inhibitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Histologically confirmed diagnosis of HR+, HER2 negative metastatic breast cancer.
- Estrogen receptor (ER) and/or progesterone receptor (PR) expression positivity is defined as at least 10% of tumor cells nuclei positive by immunohistochemistry in the sample on testing.
- HER2 negative: defined as IHC staining of 0 or 1+. If HER2 overexpression is equivocal by IHC, defined as 2+, the tumor must be non-gene amplified by FISH (ratio <2 and HER2 copy number <4).
- Progression on treatment with a CDK 4/6 inhibitor and hormonal therapy in the metastatic setting
- Patients must have measurable disease based on RECIST 1.1 criteria.
Key exclusion criteria (7 listed)
- Patients who have any systemic therapy in the metastatic setting except hormonal therapy in combination with a CDK 4/6 inhibitor. Previously palliative targeted radiation therapy is allowed. Bone targeting agents such as bisphosphonates and rank ligand inhibitors for metastatic breast cancer to the bone is also allowed prior and during this trial.
- Patients with untreated new or progressive brain metastases or leptomeningeal disease
- Use of concomitant nitrates and PDE5 inhibitors.
- Use of potent CYP3A4 inhibitors or inducers and not able to discontinue two weeks prior to enrolling onto the trial.
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints. Note: Patients with HIV or infectious hepatitis must exhibit well controlled disease with stable treatment regimen (where applicable) that in the opinion of the treating physician should not preclude them from participating in the study.
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 |
|---|---|---|
| AvasopasemAlso: GC4419Avasopasem has also been shown to exhibit both antitumor effects as well as minimal toxicity. Participants are currently taking a CDK 4/6 inhibitor and hormonal therapy | Drug | Metastatic Hormone Receptor Positive Breast Cancer |
Primary outcome
Determine Safety and Tolerability of Treatment
Time frame: Day 1 through Day 28 (each cycle is 28 days, up to 4 months
Determine the safety and tolerability of Avasopasem in combination with a CDK 4/6 inhibitor and hormonal therapy. Each cycle of treatment will be 28 days. Toxicity will be assessed starting on the first day of each 28-day treatment cycle, using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, and the incidence, nature, and severity of adverse events will be determined.All women who receive at least one dose of Avasopasem will be considered as evaluable for any toxicity and safety endpoints, as well as disease response. Patient reported outcome (PRO's) for adverse events (AE) will also be reported on day one of each cycle.
1 secondary outcome
Clinical Benefit Ratio (CBR) with addition of Avasopasem
Time frame: Day 1 through Day 28 (each cycle is 28 days, up to 4 months
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 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Kate Lathrop, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Avasopasem in people with Breast Cancer Metastatic, run by The University of Texas Health Science Center at San Antonio at 1 site 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 30 inclusion and 7 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 4 Nov 2026. 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 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?
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 Kate Lathrop, MD (210-450-1000, lathrop@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Safety and Tolerability of Treatment (time frame: Day 1 through Day 28 (each cycle is 28 days, up to 4 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 4 Nov 2026.