Advanced Solid TumorPhase 1NCT05144334
A Study of BTX-1188 in Subjects With Advanced Malignancies
A Phase 1 study testing BTX-1188 in people with Advanced Solid Tumor and Non Hodgkin Lymphoma, run by Biotheryx, Inc. at 4 sites in United States.
Trial summary
This is a multicenter, open label, nonrandomized, sequential dose escalation, multiple dose study designed to evaluate the safety, toxicity, and pharmacokinetics (PK) as well as preliminary efficacy of BTX-1188 orally administered in subjects with advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Non Hodgkin Lymphoma, Acute Myeloid Leukemia
- What is being tested?
- BTX-1188
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Jan 2022to 12 Sep 2023
- 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
- Demonstration of understanding and voluntarily signing of an informed consent form
- Age ≥ 18 years
- Part A - Relapsed or refractory AML, according to the World Health Organization (WHO) classification (Arber, Orazi, et al., 2016). Subjects must be ineligible for or have exhausted standard therapeutic options that would otherwise be likely to provide clinical benefit. Part B - B cell NHL that is refractory to or intolerant of all standard therapy or for which no standard therapy is available or histologically or cytologically documented, incurable or metastatic solid tumor that has failed all available standard therapies with known benefit.
- Subjects with solid tumors must have measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). NHL subjects must have bi-dimensionally measurable disease on cross sectional imaging by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by Lugano criteria (Cheson, Fisher, et al., 2014).
- Adequate organ function
- Females must avoid pregnancy for at least 4 weeks before beginning BTX-1188 therapy, during therapy, during dose interruptions, and for at least 4 weeks after completing therapy and agree to either abstain from sexual intercourse or use two highly effective methods of contraception (for up to 4 weeks 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 and not donate sperm (for up to 4 weeks 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-1188
- Immediate life-threatening severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
- Major trauma or major surgery within 4 weeks prior to first dose of BTX-1188.
- 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
4 sites in 1 country.
United States4 sites
The Christ Hospital
Cincinnati, Ohio, 45219
City of Hope Medical Center
Duarte, California, 91016
M.D. Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: An Open Label, Escalating Multiple Dose Study to Evaluate the Safety, Toxicity, Pharmacokinetics, and Preliminary Activity of BTX-1188 in Subjects With Advanced Malignancies
This is a multicenter, open label, nonrandomized, sequential dose escalation, multiple dose study designed to evaluate the safety, toxicity, and pharmacokinetics (PK) as well as preliminary efficacy of BTX-1188 orally administered in subjects with advanced malignancies.
Read the detailed description
Study BTX-1188-001 is a multicenter, open label, nonrandomized, sequential dose escalation study to evaluate the safety, toxicity, PK, and preliminary efficacy of BTX-1188. Dose escalation will be conducted in subjects with acute myeloid leukemia (AML) and advanced lymphoid and solid tumors. Based on the results of the dose escalation, a recommended Phase 2 dose will be determined.
- Being tested
- BTX-1188
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTX-1188Drug
One 28 day cycle of treatment will consist of 4 weeks of treatment with BTX-1188 administered orally per dosing schedule.
| Study group | Role | What they receive |
|---|---|---|
| BTX-1188 Dose Cohort 1 | Experimental | Starting dose of BTX-1188 administered orally per dosing schedule Receives: Drug: BTX-1188 |
| BTX-1188 Dose Cohort 2 | Experimental | First dose escalation of BTX-1188 administered orally per dosing schedule Receives: Drug: BTX-1188 |
| BTX-1188 Dose Cohort 3 | Experimental | Second dose escalation of BTX-1188 administered orally per dosing schedule Receives: Drug: BTX-1188 |
| BTX-1188 Dose Cohort 4 | Experimental | Third dose escalation of BTX-1188 administered orally per dosing schedule Receives: Drug: BTX-1188 |
| BTX-1188 Dose Cohort 5 | Experimental | Fourth dose escalation of BTX-1188 administered orally per dosing schedule Receives: Drug: BTX-1188 |
| BTX-1188 Dose Cohort 6 | Experimental | Fifth dose escalation of BTX-1188 administered orally per dosing schedule Receives: Drug: BTX-1188 |
| BTX-1188 Dose Cohort 7 | Experimental | Sixth dose escalation of BTX-1188 administered orally per dosing schedule Receives: Drug: BTX-1188 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] with BTX-1188 in subjects with advanced malignancies
To examine the incidence of clinical and laboratory adverse events after multiple doses of BTX-1188
Measured: From first dose of BTX-1188 through 30 days after the last BTX-1188 treatment
To determine the recommended Phase 2 dose (RP2D) of BTX-1188 in subjects with advanced malignancies
To assess number of patients experiencing dose-limiting toxicities (DLTs)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (10)
Maximum Plasma Concentration of BTX-1188
To evaluate the maximum observed concentration (Cmax) after single and repeated oral, once daily doses of BTX-1188
Measured: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, and 8 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
Peak Plasma Concentration of BTX-1188
To evaluate the observed time of peak concentration (Tmax) after single and repeated oral, once daily doses of BTX-1188
Measured: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, and 8 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
Area under the plasma concentration of BTX-1188
To evaluate the area under the curve (AUC) plasma-concentration after single and repeated oral, once daily doses of BTX-1188.
Measured: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, and 8 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
Half-life of BTX-1188
To evaluate the half-life of BTX-1188 after single and repeated oral, once daily doses of BTX-1188.
Measured: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, and 8 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
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.
Best response
To evaluate the complete remission/response [CR], CR with incomplete blood count recovery [CRi], morphologic leukemia free state [MLFS], partial remission/response [PR], stable disease or progression as determined by the specific disease response criteria.
Measured: For subjects with AML, response will be evaluated at the end of each cycle (each cycle is 28 days) and after the last dose of BTX-1188 (approximately 36 months). For subjects with NHL or solid tumors, response will be evaluated every 8-weeks.
Disease Control Rate (DCR)
To evaluate the DCR (response + stable disease) as determined by the specific disease response criteria.
Measured: For subjects with AML, response will be evaluated at the end of each cycle (each cycle is 28 days) and after the last dose of BTX-1188 (approximate 36 months). For subjects with NHL or solid tumors, response will be evaluated every 8-weeks.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start24 Jan 2022
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Why it stopped: Business 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.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotheryx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tracy Lawhon, Study director, Biotheryx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144334
- Sponsor's protocol ID
- BTX-1188-001
- Status last verified
- Oct 2026
- First submitted
- 9 Nov 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. 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, Pharmacokinetics, and Preliminary Activity of BTX-1188 in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT05144334
- Acronym / sponsor ID
- BTX-1188-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Biotheryx, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 3 Dec 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, multiple dose study designed to evaluate the safety, toxicity, and pharmacokinetics (PK) as well as preliminary efficacy of BTX-1188 orally administered in subjects with advanced malignancies.
Detailed description
Study BTX-1188-001 is a multicenter, open label, nonrandomized, sequential dose escalation study to evaluate the safety, toxicity, PK, and preliminary efficacy of BTX-1188. Dose escalation will be conducted in subjects with acute myeloid leukemia (AML) and advanced lymphoid and solid tumors. Based on the results of the dose escalation, a recommended Phase 2 dose will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| BTX-1188 Dose Cohort 1 | Experimental | Drug: BTX-1188Starting dose of BTX-1188 administered orally per dosing schedule |
| BTX-1188 Dose Cohort 2 | Experimental | Drug: BTX-1188First dose escalation of BTX-1188 administered orally per dosing schedule |
| BTX-1188 Dose Cohort 3 | Experimental | Drug: BTX-1188Second dose escalation of BTX-1188 administered orally per dosing schedule |
| BTX-1188 Dose Cohort 4 | Experimental | Drug: BTX-1188Third dose escalation of BTX-1188 administered orally per dosing schedule |
| BTX-1188 Dose Cohort 5 | Experimental | Drug: BTX-1188Fourth dose escalation of BTX-1188 administered orally per dosing schedule |
| BTX-1188 Dose Cohort 6 | Experimental | Drug: BTX-1188Fifth dose escalation of BTX-1188 administered orally per dosing schedule |
| BTX-1188 Dose Cohort 7 | Experimental | Drug: BTX-1188Sixth dose escalation of BTX-1188 administered orally per dosing schedule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Demonstration of understanding and voluntarily signing of an informed consent form
- Age ≥ 18 years
- Part A - Relapsed or refractory AML, according to the World Health Organization (WHO) classification (Arber, Orazi, et al., 2016). Subjects must be ineligible for or have exhausted standard therapeutic options that would otherwise be likely to provide clinical benefit. Part B - B cell NHL that is refractory to or intolerant of all standard therapy or for which no standard therapy is available or histologically or cytologically documented, incurable or metastatic solid tumor that has failed all available standard therapies with known benefit.
- Subjects with solid tumors must have measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). NHL subjects must have bi-dimensionally measurable disease on cross sectional imaging by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by Lugano criteria (Cheson, Fisher, et al., 2014).
- Adequate organ function
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-1188
- Immediate life-threatening severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
- Major trauma or major surgery within 4 weeks prior to first dose of BTX-1188.
- 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-1188One 28 day cycle of treatment will consist of 4 weeks of treatment with BTX-1188 administered orally per dosing schedule. | Drug | BTX-1188 Dose Cohort 1, BTX-1188 Dose Cohort 2, BTX-1188 Dose Cohort 3, BTX-1188 Dose Cohort 4, BTX-1188 Dose Cohort 5, BTX-1188 Dose Cohort 6, BTX-1188 Dose Cohort 7 |
Primary outcome
To evaluate the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] with BTX-1188 in subjects with advanced malignancies
Time frame: From first dose of BTX-1188 through 30 days after the last BTX-1188 treatment
To examine the incidence of clinical and laboratory adverse events after multiple doses of BTX-1188
To determine the recommended Phase 2 dose (RP2D) of BTX-1188 in subjects with advanced malignancies
Time frame: At the end of Cycle 1 (each cycle is 28 days)
To assess number of patients experiencing dose-limiting toxicities (DLTs)
10 secondary outcomes
Maximum Plasma Concentration of BTX-1188
Time frame: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, and 8 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
Peak Plasma Concentration of BTX-1188
Time frame: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, and 8 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
Area under the plasma concentration of BTX-1188
Time frame: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, and 8 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
Half-life of BTX-1188
Time frame: PK samples are collected at pre-dose and post-dose at 1, 2, 3, 5, and 8 hours on Days 1 and 5 of Cycle 1 (each cycle is 28 days).
Objective response rate (ORR)
Time frame: Up to 2 years after the last treatment or upon death.
Best response
Time frame: For subjects with AML, response will be evaluated at the end of each cycle (each cycle is 28 days) and after the last dose of BTX-1188 (approximately 36 months). For subjects with NHL or solid tumors, response will be evaluated every 8-weeks.
Disease Control Rate (DCR)
Time frame: For subjects with AML, response will be evaluated at the end of each cycle (each cycle is 28 days) and after the last dose of BTX-1188 (approximate 36 months). For subjects with NHL or solid tumors, response will be evaluated every 8-weeks.
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.
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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.
Tracy Lawhon study director
Biotheryx, 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 BTX-1188 in people with Advanced Solid Tumor and Non Hodgkin Lymphoma, run by Biotheryx, 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 7 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: stopped early, as of the sponsor's last update on 15 Oct 2026. 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 was stopped early (reason given: Business decision). Results are not available in the source record.
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?
To evaluate the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] with BTX-1188 in subjects with advanced malignancies (time frame: From first dose of BTX-1188 through 30 days after the last BTX-1188 treatment). 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?
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 15 Oct 2026.