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BTX-1188 for Acute Myeloid Leukemia
Phase 1
Waitlist Available
Research Sponsored by Biotheryx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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).
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new oral drug called BTX-1188 in patients with severe cancers like AML and advanced tumors. The study aims to find out if the drug is safe, how it is processed by the body, and if it can help treat these cancers.
Eligible Conditions
- Acute Myeloid Leukemia
- Non-Hodgkin's Lymphoma
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine the recommended Phase 2 dose (RP2D) of BTX-1188 in subjects with advanced malignancies
To evaluate the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] with BTX-1188 in subjects with advanced malignancies
Secondary study objectives
Area under the plasma concentration of BTX-1188
Best response
Disease Control Rate (DCR)
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Group I: BTX-1188 Dose Cohort 7Experimental Treatment1 Intervention
Sixth dose escalation of BTX-1188 administered orally per dosing schedule
Group II: BTX-1188 Dose Cohort 6Experimental Treatment1 Intervention
Fifth dose escalation of BTX-1188 administered orally per dosing schedule
Group III: BTX-1188 Dose Cohort 5Experimental Treatment1 Intervention
Fourth dose escalation of BTX-1188 administered orally per dosing schedule
Group IV: BTX-1188 Dose Cohort 4Experimental Treatment1 Intervention
Third dose escalation of BTX-1188 administered orally per dosing schedule
Group V: BTX-1188 Dose Cohort 3Experimental Treatment1 Intervention
Second dose escalation of BTX-1188 administered orally per dosing schedule
Group VI: BTX-1188 Dose Cohort 2Experimental Treatment1 Intervention
First dose escalation of BTX-1188 administered orally per dosing schedule
Group VII: BTX-1188 Dose Cohort 1Experimental Treatment1 Intervention
Starting dose of BTX-1188 administered orally per dosing schedule
Find a Location
Who is running the clinical trial?
Biotheryx, Inc.Lead Sponsor
1 Previous Clinical Trials
82 Total Patients Enrolled
BioTheryX, Inc.Lead Sponsor
2 Previous Clinical Trials
192 Total Patients Enrolled
Dung "Zung" Thai, MD, PhDStudy DirectorBioTheryX, Inc.
1 Previous Clinical Trials
112 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced side effects from previous cancer treatments that have not improved or are still causing moderate or severe problems, except for hair loss or mild thyroid issues caused by immunotherapy.You have a serious heart condition that could affect your participation in the study.You have severe complications from leukemia that are immediately life-threatening, such as uncontrolled bleeding, severe pneumonia, or a condition called disseminated intravascular coagulation.You have a history of serious brain or nervous system problems caused by medications.Part A: You have a type of leukemia called AML that has come back or is not responding to treatment. You have tried all the standard treatments that are usually effective, but they didn't work for you.
Part B: You have a type of cancer called B cell NHL or a type of solid tumor that has spread to other parts of your body. It is either not responding to any standard treatments, or you cannot tolerate those treatments. There is no other known treatment available that can cure or control your cancer.
Research Study Groups:
This trial has the following groups:- Group 1: BTX-1188 Dose Cohort 6
- Group 2: BTX-1188 Dose Cohort 1
- Group 3: BTX-1188 Dose Cohort 3
- Group 4: BTX-1188 Dose Cohort 2
- Group 5: BTX-1188 Dose Cohort 4
- Group 6: BTX-1188 Dose Cohort 5
- Group 7: BTX-1188 Dose Cohort 7
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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