Advanced Solid TumorPhase 1NCT04872166
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
A Phase 1 study testing BTX-A51 in people with Advanced Solid Tumor and Metastatic Breast Cancer, run by Edgewood Oncology Inc. at 6 sites in United States.
Trial summary
This is a multicenter, open label, nonrandomized, sequential dose escalation/dose ranging, multiple dose study designed to evaluate the safety, toxicity, and PK as well as preliminary efficacy of BTX-A51 alone and in combination with fulvestrant in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Breast Cancer
- What is being tested?
- BTX-A51
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 6 sitesUnited States
- Study dates
- 7 Jun 2021to May 2027
- 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
- Demonstration of understanding and voluntarily signing of an informed consent form
- Age ≥ 18 years
- Histologically or cytologically documented, incurable or metastatic solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available
- Phase 1b and 1c only: Histologically confirmed diagnosis of ER+, HER2- mBC not amenable to resection or radiation therapy with curative intent.
- Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- Adequate organ function
- Females of childbearing age must not be pregnant at time of Screening/beginning of treatment and agree to either abstain from sexual intercourse or use highly effective methods of contraception (for up to 3 months after last dose of study drug)
- Males sexually active with a woman of childbearing age must agree to use barrier method of birth control during and after the study (up to 3 months after last dose of study drug)
Who cannot join
- Life expectancy <3 months, as determined by the Investigator.
- Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of BTX-A51
- Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of BTX-A51
- Major trauma or major surgery within 4 weeks prior to first dose of BTX-A51.
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤1 except for alopecia or Grade ≤2 immunotherapy-related thyroid toxicity.
- History of, or known, central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity.
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- Clinically significant cardiac disease
- Active uncontrolled systemic fungal, bacterial, mycobacterial, or viral infection
- Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)
- Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
- Second primary malignancy that has not been in remission for greater than 3 years
- Any serious underlying medical (e.g., pulmonary, renal, hepatic, gastrointestinal, or neurological) or psychiatric condition (e.g., alcohol or drug abuse, dementia or altered mental status) or any issue that would limit compliance with study requirements
- Pregnant, lactating, or breastfeeding.
- Participation or plans to participate in another interventional clinical study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Edgar Bautista, BS contact
6 sites in 1 country
United States6 sites, 4 recruiting
- Completed
The Linder Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Senthil Damodaran, MD, PhD
- Recruiting
Florida Cancer Specialists
Lake Mary, Florida, 32746
Alexander Philipovskiy, MD, PhD
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Denise A Yardley, MD
- Completed
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
Judy Wang, MD
About this study
Official title: An Open Label, Escalating Multiple Dose Study to Evaluate the Safety, Toxicity, and Pharmacokinetics of BTX A51 Alone and in Combination With Fulvestrant in Subjects With Advanced Solid Tumors and Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer
This is a multicenter, open label, nonrandomized, sequential dose escalation/dose ranging, multiple dose study designed to evaluate the safety, toxicity, and PK as well as preliminary efficacy of BTX-A51 alone and in combination with fulvestrant in subjects with advanced solid tumors. The study will be done in three phases, described below.
Phase 1a (Dose Escalation Phase):
Read more
The Phase 1a portion is designed to determine the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of orally administered BTX-A51. BTX-A51 will be administered once daily on a weekly schedule of 5 days on/2 days off. Dose escalation will proceed according to a modified 3+3 design. Each cycle will consist of 28 days (4 weeks), and the DLT observation period will be the first cycle (i.e., 28 days after initiation of dosing). A DLT may be observed in no more than 0 out of 3 or 1 out of 6 subjects who have completed the DLT observation period before the next cohort initiates accrual. Barring DLT, sequential dose escalation of BTX-A51 is planned with up to a total of 6 dose levels; on the basis of these an MTD will be identified. The MTD is defined as the highest dose level with a subject incidence of DLTs of 0 or 1 out of 6 during the first 28 days of study drug dosing. A minimum of 6 subjects needs to be treated at a dose level before this dose level can be deemed as the MTD.
Phase 1b (Monotherapy Dose Ranging Phase):
Dose expansion may begin when the RP2D has been determined. Up to 40 additional subjects at each of the 2 dose levels will be enrolled to evaluate safety and preliminary efficacy of BTX-A51 in subjects with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), GATA3 mutant (mt) and wild-type (wt) metastatic breast cancer (mBC). Dosing in this phase of the study consists of the first cycle of therapy (i.e., 28 days).
Phase 1c (Combination Safety Phase):
The Phase 1c portion will evaluate the safety and tolerability of orally administered BTX-A51 at two dose levels combined with fulvestrant. The first combo cohort may be initiated after DEC review of the 6 subject lead-in phase of the high dose monotherapy cohort in Phase 1b. Dose escalation will proceed according to a 3+3 design. Each cycle will consist of 28 days (4 weeks), and the DLT observation period will be the first cycle (i.e., 28 days after initiation of dosing).
- Conditions
- Advanced Solid Tumor, Metastatic Breast Cancer
- Being tested
- BTX-A51
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTX-A51Drug
One 28 day cycle of treatment will consist of 4 weeks of treatment with a weekly dosing schedule of up to 5 days per weekf.
| Study group | Role | What they receive |
|---|---|---|
| BTX-A51 Dose Cohort 1 | Experimental | Starting dose (SD) of BTX-A51 administered orally 5 times per week in a 28-day cycle Receives: Drug: BTX-A51 |
| BTX-A51 Dose Cohort 2 | Experimental | Up to 2-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle Receives: Drug: BTX-A51 |
| BTX-A51 Dose Cohort 3 | Experimental | Up to 3.5-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle Receives: Drug: BTX-A51 |
| BTX-A51 Dose Cohort 4 | Experimental | Up to 5-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle Receives: Drug: BTX-A51 |
| BTX-A51 Dose Cohort 5 | Experimental | Up to 7-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle Receives: Drug: BTX-A51 |
| BTX-A51 Dose Cohort 6 | Experimental | Up to 10-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle Receives: Drug: BTX-A51 |
| BTX-A51 in Combination with Fulvestrant Cohort 1 | Experimental | Starting dose (SD) of BTX-A51 administered orally 3 times per week in a 28-day cycle; fulvestrant administered as a 500-mg intramuscular injection on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles. Receives: Drug: BTX-A51 |
| BTX-A51 in Combination with Fulvestrant Cohort 2 | Experimental | Up to 2-times the SD of BTX-A51 administered orally 3 times per week in a 28-day cycle; fulvestrant administered as a 500-mg intramuscular injection on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles. Receives: Drug: BTX-A51 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events after BTX-A51 administration alone and in combination with fulvestrant
To examine the incidence of clinical and laboratory adverse events after multiple doses of BTX-A51 alone and in combination with fulvestrant.
Measured: From first dose of BTX-A51 through 30 days after the last BTX-A51 alone and in combination with fulvestrant treatment (subjects will be offered continued access to study BTX-A51 until disease progression or unacceptable toxicity)
Defining the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BTX-A51alone and in combination with fulvestrant
To assess number of patients experiencing dose-limiting toxicities (DLTs)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (7)
Objective response rate (ORR)
To evaluate the objective response rate (ORR) as determined by the specific disease response criteria
Measured: Up to 2 years after the last treatment or upon death.
Duration of response (DoR)
To evaluate the duration of response (DoR), defined as time from the date of first documentation of response to the date of the first documentation of progressive disease (PD), or death due to any cause
Measured: Up to 2 years after the last treatment or upon death.
Progression free survival (PFS)
To examine the the progression free survival (PFS), defined as time from the date of first dose of study treatment to the first date of documentation of PD, or death due to any cause
Measured: Up to 2 years after the last treatment or upon death.
Overall survival (OS)
To examine the overall survival (OS), defined as time from the date of first dose of study treatment to death due to any cause
Measured: Up to 2 years after the last treatment or upon death.
Peak Plasma Concentration of BTX-A51
To evaluate the maximum observed concentration (Cmax) after single and repeated oral, once daily doses of BTX-A51
Measured: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, 8, and 24 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
Area under the plasma concentration of BTX-A51
To evaluate the area under the curve (AUC) plasma-concentration after single and repeated oral, once daily doses of BTX-A51
Measured: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, 8, and 24 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
Half-life of BTX-A51
To evaluate the half-life of BTX-A51 after single and repeated oral, once daily doses of BTX-A51
Measured: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, 8, and 24 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start7 Jun 2021
- Primary completionMay 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edgewood Oncology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zung Thai, MD, Study director, Edgewood Oncology Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872166
- Sponsor's protocol ID
- BTX-A51-002
- Status last verified
- Jan 2025
- First submitted
- 22 Apr 2021
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ball BJ, Xiao W, Borthakur G, Nguyen LXT, Valerio M, Venkatachalam A, Marcucci G, Stein AS, Thai DL, Cook DN, Chan K, Persaud S, Levine RL, Abdel-Wahab O, Ben-Neriah Y, Stein EM. Phase I first-in-human dose escalation study of the oral casein kinase 1alpha and cyclin dependent kinase 7/9 inhibitor BTX A51 in advanced MDS and AML. J Hematol Oncol. 2025 Jul 15;18(1):73. doi: 10.1186/s13045-025-01724-z.
PubMed 40665325
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Escalating Multiple Dose Study to Evaluate the Safety, Toxicity, and Pharmacokinetics of BTX A51 Alone and in Combination With Fulvestrant in Subjects With Advanced Solid Tumors and Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04872166
- Acronym / sponsor ID
- BTX-A51-002
- Conditions
- Advanced Solid Tumor, Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Edgewood Oncology Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 May 2021 (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 is a multicenter, open label, nonrandomized, sequential dose escalation/dose ranging, multiple dose study designed to evaluate the safety, toxicity, and PK as well as preliminary efficacy of BTX-A51 alone and in combination with fulvestrant in subjects with advanced solid tumors. The study will be done in three phases, described below.
Phase 1a (Dose Escalation Phase):
The Phase 1a portion is designed to determine the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of orally administered BTX-A51. BTX-A51 will be administered once daily on a weekly schedule of 5 days on/2 days off. Dose escalation will proceed according to a modified 3+3 design. Each cycle will consist of 28 days (4 weeks), and the DLT observation period will be the first cycle (i.e., 28 days after initiation of dosing). A DLT may be observed in no more than 0 out of 3 or 1 out of 6 subjects who have completed the DLT observation period before the next cohort initiates accrual. Barring DLT, sequential dose escalation of BTX-A51 is planned with up to a total of 6 dose levels; on the basis of these an MTD will be identified. The MTD is defined as the highest dose level with a subject incidence of DLTs of 0 or 1 out of 6 during the first 28 days of study drug dosing. A minimum of 6 subjects needs to be treated at a dose level before this dose level can be deemed as the MTD.
Phase 1b (Monotherapy Dose Ranging Phase):
Dose expansion may begin when the RP2D has been determined. Up to 40 additional subjects at each of the 2 dose levels will be enrolled to evaluate safety and preliminary efficacy of BTX-A51 in subjects with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), GATA3 mutant (mt) and wild-type (wt) metastatic breast cancer (mBC). Dosing in this phase of the study consists of the first cycle of therapy (i.e., 28 days).
Phase 1c (Combination Safety Phase):
The Phase 1c portion will evaluate the safety and tolerability of orally administered BTX-A51 at two dose levels combined with fulvestrant. The first combo cohort may be initiated after DEC review of the 6 subject lead-in phase of the high dose monotherapy cohort in Phase 1b. Dose escalation will proceed according to a 3+3 design. Each cycle will consist of 28 days (4 weeks), and the DLT observation period will be the first cycle (i.e., 28 days after initiation of dosing).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| BTX-A51 Dose Cohort 1 | Experimental | Drug: BTX-A51Starting dose (SD) of BTX-A51 administered orally 5 times per week in a 28-day cycle |
| BTX-A51 Dose Cohort 2 | Experimental | Drug: BTX-A51Up to 2-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle |
| BTX-A51 Dose Cohort 3 | Experimental | Drug: BTX-A51Up to 3.5-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle |
| BTX-A51 Dose Cohort 4 | Experimental | Drug: BTX-A51Up to 5-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle |
| BTX-A51 Dose Cohort 5 | Experimental | Drug: BTX-A51Up to 7-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle |
| BTX-A51 Dose Cohort 6 | Experimental | Drug: BTX-A51Up to 10-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle |
| BTX-A51 in Combination with Fulvestrant Cohort 1 | Experimental | Drug: BTX-A51Starting dose (SD) of BTX-A51 administered orally 3 times per week in a 28-day cycle; fulvestrant administered as a 500-mg intramuscular injection on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles. |
| BTX-A51 in Combination with Fulvestrant Cohort 2 | Experimental | Drug: BTX-A51Up to 2-times the SD of BTX-A51 administered orally 3 times per week in a 28-day cycle; fulvestrant administered as a 500-mg intramuscular injection on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Demonstration of understanding and voluntarily signing of an informed consent form
- Age ≥ 18 years
- Histologically or cytologically documented, incurable or metastatic solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available
- Phase 1b and 1c only: Histologically confirmed diagnosis of ER+, HER2- mBC not amenable to resection or radiation therapy with curative intent.
- Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Key exclusion criteria (14 listed)
- Life expectancy <3 months, as determined by the Investigator.
- Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of BTX-A51
- Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of BTX-A51
- Major trauma or major surgery within 4 weeks prior to first dose of BTX-A51.
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤1 except for alopecia or Grade ≤2 immunotherapy-related thyroid toxicity.
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 |
|---|---|---|
| BTX-A51One 28 day cycle of treatment will consist of 4 weeks of treatment with a weekly dosing schedule of up to 5 days per weekf. | Drug | BTX-A51 Dose Cohort 1, BTX-A51 Dose Cohort 2, BTX-A51 Dose Cohort 3, BTX-A51 Dose Cohort 4, BTX-A51 Dose Cohort 5, BTX-A51 Dose Cohort 6, BTX-A51 in Combination with Fulvestrant Cohort 1, BTX-A51 in Combination with Fulvestrant Cohort 2 |
Primary outcome
Incidence of adverse events after BTX-A51 administration alone and in combination with fulvestrant
Time frame: From first dose of BTX-A51 through 30 days after the last BTX-A51 alone and in combination with fulvestrant treatment (subjects will be offered continued access to study BTX-A51 until disease progression or unacceptable toxicity)
To examine the incidence of clinical and laboratory adverse events after multiple doses of BTX-A51 alone and in combination with fulvestrant.
Defining the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BTX-A51alone and in combination with fulvestrant
Time frame: At the end of Cycle 1 (each cycle is 28 days)
To assess number of patients experiencing dose-limiting toxicities (DLTs)
7 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 2 years after the last treatment or upon death.
Duration of response (DoR)
Time frame: Up to 2 years after the last treatment or upon death.
Progression free survival (PFS)
Time frame: Up to 2 years after the last treatment or upon death.
Overall survival (OS)
Time frame: Up to 2 years after the last treatment or upon death.
Peak Plasma Concentration of BTX-A51
Time frame: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, 8, and 24 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
Area under the plasma concentration of BTX-A51
Time frame: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, 8, and 24 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
Half-life of BTX-A51
Time frame: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, 8, and 24 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
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 30 Jan 2025.
- Derived from this study: PubMed 40665325Ball BJ, Xiao W, Borthakur G, Nguyen LXT, Valerio M, Venkatachalam A, Marcucci G, Stein AS, Thai DL, Cook DN, Chan K, Persaud S, Levine RL, Abdel-Wahab O, Ben-Neriah Y, Stein EM. Phase I first-in-human dose escalation study of the oral casein kinase 1alpha and cyclin dependent kinase 7/9 inhibitor BTX A51 in advanced MDS and AML. J Hematol Oncol. 2025 Jul 15;18(1):73. doi: 10.1186/s13045-025-01724-z.
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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.
Edgar Bautista, BS contact
Zung Thai, MD study director
Edgewood Oncology Inc.
6 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 BTX-A51 in people with Advanced Solid Tumor and Metastatic Breast Cancer, run by Edgewood Oncology Inc. at 6 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 8 inclusion and 14 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 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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 Zung Thai, MD (415-225-9338, zung@edgewoodonc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events after BTX-A51 administration alone and in combination with fulvestrant (time frame: From first dose of BTX-A51 through 30 days after the last BTX-A51 alone and in combination with fulvestrant treatment (subjects will be offered continued access to study BTX-A51 until disease progression or unacceptable toxicity)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04872166, which also lists 1 linked publication.
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 30 Jan 2025.