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BTX-1188 for Non-Hodgkin's Lymphoma

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

Summary

This trial is testing a new drug for safety, side effects, and how well it works in people with advanced cancer.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Acute Myeloid Leukemia
  • Solid Tumors

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).
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, and 8 hours on days 1 and 5 of cycle 1 (each cycle is 28 days). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Area under the plasma concentration of BTX-1188
Best response
Disease Control Rate (DCR)
+7 more

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
2 Previous Clinical Trials
192 Total Patients Enrolled
Dung "Zung" Thai, MD, PhDStudy DirectorBioTheryX, Inc.
1 Previous Clinical Trials
112 Total Patients Enrolled
Tracy LawhonStudy DirectorBioTheryX, Inc.

Media Library

BTX-1188 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05144334 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: BTX-1188 Dose Cohort 6, BTX-1188 Dose Cohort 1, BTX-1188 Dose Cohort 3, BTX-1188 Dose Cohort 2, BTX-1188 Dose Cohort 4, BTX-1188 Dose Cohort 5, BTX-1188 Dose Cohort 7
Non-Hodgkin's Lymphoma Clinical Trial 2023: BTX-1188 Highlights & Side Effects. Trial Name: NCT05144334 — Phase 1
BTX-1188 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05144334 — Phase 1
~2 spots leftby Jul 2025