OBT076, a CD205-directed antibody-drug conjugate for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+3 More
OBT076, a CD205-directed antibody-drug conjugate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a new cancer drug, OBT076, to see if it is safe and effective. OBT076 is made of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. Researchers will test different doses of OBT076 to find the highest dose that is safe and still works against the cancer.

Eligible Conditions
  • Breast Cancer
  • Tumors, Solid

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: 2 years

1 year
Area under the Plasma Concentration versus Time Curve (AUC) of OBT076
Clearance (CL) of OBT076
Half-Life [T1/2] of OBT076
Incidence of Adverse Events (AEs) as assessed by NCI CTCAE (Version 5)
Maximum Plasma Concentration [Cmax] of OBT076
Percentage of subjects with dose-limiting toxicities (DLTs) as assessed by NCI CTCAE (Version 5)
Time Taken to Reach the Maximum Plasma Concentration [Tmax] of OBT076
Volume of Distribution (Vd) of OBT076
2 years
Clinical Benefit Ratio (CBR)
Duration of Response (DoR)
Overall Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)
Quantification of Immune Cells (ICs) in Tumor Microenvironment (TME)
Quantification of Peripheral Blood CD205+ Cells
Quantification of Serum Protein

Trial Safety

Safety Progress

1 of 3

Other trials for Breast Cancer

Trial Design

1 Treatment Group

OBT076 Dose Escalation and Expansion
1 of 1
Experimental Treatment

150 Total Participants · 1 Treatment Group

Primary Treatment: OBT076, a CD205-directed antibody-drug conjugate · No Placebo Group · Phase 1

OBT076 Dose Escalation and Expansion
Drug
Experimental Group · 1 Intervention: OBT076, a CD205-directed antibody-drug conjugate · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Oxford BioTherapeutics LtdLead Sponsor
Rutika Mehta, MDPrincipal InvestigatorMoffitt Cancer Center
Olivier Rixe, MDPrincipal InvestigatorQuantum Santa Fe
Gary Schwartz, MDPrincipal InvestigatorColumbia University
7 Previous Clinical Trials
244 Total Patients Enrolled
2 Trials studying Breast Cancer
17 Patients Enrolled for Breast Cancer
Lee Rosen, MDPrincipal InvestigatorUniversity of California, Los Angeles
4 Previous Clinical Trials
207 Total Patients Enrolled
Monica Mita, MDPrincipal InvestigatorCedars-Sinai
9 Previous Clinical Trials
299 Total Patients Enrolled
5 Trials studying Breast Cancer
132 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have recurrent or metastatic cancer defined by ASCO-CAP guidelines as negative in situ hybridization test or an IHC status of 0, 1+, or 2+.
You are ≥ 18 years of age (at the time of signing the ICF) with non-curative recurrent and/or metastatic solid tumors for which a standard therapy is no longer effective.
You have histologically and/or cytologically confirmed solid tumors.
You have a tumor that is positive for CD205 antigen by IHC staining.
Subject has measurable disease.
You have adequate bone marrow function.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: October 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.