adagloxad simolenin combined with OBI-821 for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Breast Canceradagloxad simolenin combined with OBI-821 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new combination drug to treat triple negative breast cancer.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 7 years

2 years
Incidence and severity of adverse events (AEs) [Time Frame: AEs will be noted as it occurs, with a timeframe from beginning of randomization to 4 weeks after last dose of study treatment.]
5 years
Therapeutic procedure
7 years
Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Breast cancer-free interval (BCFI).
Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Distant disease-free survival (DDFS).
Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Overall Survival (OS).
Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Quality of Life (QoL).

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Standard of Care treatment
1 of 2
Adagloxad simolenin + OBI-821 in conjunction with SOC
1 of 2

Active Control

Experimental Treatment

668 Total Participants · 2 Treatment Groups

Primary Treatment: adagloxad simolenin combined with OBI-821 · No Placebo Group · Phase 3

Adagloxad simolenin + OBI-821 in conjunction with SOCExperimental Group · 3 Interventions: adagloxad simolenin combined with OBI-821, Globo H IHC Assay, Standard of care treatment · Intervention Types: Biological, Device, Other
Standard of Care treatmentActiveComparator Group · 2 Interventions: Globo H IHC Assay, Standard of care treatment · Intervention Types: Device, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 7 years

Who is running the clinical trial?

OBI Pharma, IncLead Sponsor
7 Previous Clinical Trials
887 Total Patients Enrolled
Hope Rugo, MDStudy ChairUniversity of California, San Francisco
2 Previous Clinical Trials
154 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a tumor that is estrogen receptor negative (ER-)/progesterone receptor negative (PR-)/human epidermal growth factor 2 negative (HER2-), and negative HER2/neu- status.
You have documented radiographic and histopathologic confirmed primary localized invasive breast cancer.
You have HER2 gene amplification or HER2 gene copy number of <6 signals/nucleus.
You have HER2/neu chromosome 17 (CEP17) non-amplified ratio of <2.
You have been diagnosed with Stage IIB, Stage IIIA, Stage IIIB, or Stage IIIC disease according to the 8th edition of the AJCC Cancer Staging Manual.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
65+100.0%
What site did they apply to?
Long Beach Memorial Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Phone Call100.0%
Most responsive sites:
  1. Long Beach Memorial Medical Center: < 24 hours