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BTX-A51 for Cancer

Phase 1
Recruiting
Research Sponsored by Edgewood Oncology Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Histologically or cytologically documented, incurable or metastatic solid tumor or B cell NHL that is refractory to or intolerant of all standard therapy or for which no standard therapy is available
Must not have
Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of BTX-A51
Clinically significant cardiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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).
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to study the safety and effectiveness of BTX-A51 in people with advanced solid tumors or NHL. The trial will have two parts: in the first part, the dose of BTX-A51 will be increased until the maximum tolerated dose is found; in the second part, the safety and effectiveness of BTX-A51 will be studied in people with MYC genomic amplified/overexpressed tumors.

Who is the study for?
Adults with advanced solid tumors or B cell Non-Hodgkin Lymphoma that's resistant to standard treatments can join. They must have measurable disease, not be pregnant, agree to use contraception, and have good organ function. Those with MYC amplified/overexpressed tumors are eligible for the expansion phase.
What is being tested?
The trial is testing BTX-A51, an oral drug given on a weekly schedule (5 days on/2 days off). It has two phases: Phase 1a finds the safest dose by slowly increasing amounts; Phase 1b expands this dose to more patients focusing on those with specific genetic tumor features.
What are the potential side effects?
Possible side effects of BTX-A51 include reactions related to the maximum tolerated dose which could involve fatigue, digestive issues or other organ-related symptoms based on previous similar trials. Specific side effects will be monitored during the first cycle of treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is advanced, cannot be cured with standard treatments, or I cannot tolerate them.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken more than 10 mg of steroids daily in the last month.
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I have a serious heart condition.
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I do not have any ongoing serious infections.
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I have had serious brain-related side effects from drugs or have brain disease.
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I have another cancer that has been in remission for less than 3 years.
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I have active hepatitis B or C.
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I haven't had cancer treatment in the last 3 weeks.
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My side effects from previous cancer treatments are mild, except for hair loss or thyroid issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Defining the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BTX-A51
Safety and tolerability of BTX-A51
Secondary study objectives
Area under the plasma concentration of BTX-A51
Duration of response (DoR)
Half-life of BTX-A51
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: BTX-A51 Dose Cohort 6Experimental Treatment1 Intervention
Up to 10-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
Group II: BTX-A51 Dose Cohort 5Experimental Treatment1 Intervention
Up to 7-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
Group III: BTX-A51 Dose Cohort 4Experimental Treatment1 Intervention
Up to 5-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
Group IV: BTX-A51 Dose Cohort 3Experimental Treatment1 Intervention
Up to 3.5-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
Group V: BTX-A51 Dose Cohort 2Experimental Treatment1 Intervention
Up to 2-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
Group VI: BTX-A51 Dose Cohort 1Experimental Treatment1 Intervention
Starting dose (SD) of BTX-A51 administered orally 5 times per week in a 28-day cycle

Find a Location

Who is running the clinical trial?

Edgewood Oncology Inc.Lead Sponsor
2 Previous Clinical Trials
92 Total Patients Enrolled
BioTheryX, Inc.Lead Sponsor
2 Previous Clinical Trials
88 Total Patients Enrolled
Zung Thai, MDStudy DirectorEdgewood Oncology Inc.
5 Previous Clinical Trials
668 Total Patients Enrolled
Dung "Zung" Thai, MD, PhDStudy DirectorBioTheryX, Inc.
1 Previous Clinical Trials
8 Total Patients Enrolled
Tracy Lawhon, JDStudy DirectorBioTheryX, Inc.
1 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

BTX-A51 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04872166 — Phase 1
Breast Cancer Research Study Groups: BTX-A51 Dose Cohort 1, BTX-A51 Dose Cohort 5, BTX-A51 Dose Cohort 3, BTX-A51 Dose Cohort 4, BTX-A51 Dose Cohort 2, BTX-A51 Dose Cohort 6
Breast Cancer Clinical Trial 2023: BTX-A51 Highlights & Side Effects. Trial Name: NCT04872166 — Phase 1
BTX-A51 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04872166 — Phase 1
~29 spots leftby May 2026
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