A Phase I/Ib, open-label, dose finding study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of OBT076, a CD205-directed antibody-drug conjugate, in recurrent and/or metastatic CD205-positive solid tumors

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511884-27-00

Acronym

OBT076-001

Enrollment

180

Registered

2024-05-21

Start date

2022-11-09

Completion date

Unknown

Last updated

2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CD205+ve recurrent and/or metastatic tumor types including but not limited to gastric cancer, endometrial or ovarian cancer. Other tumor types may be added as more data become available., NSCLC

Brief summary

safety endpoints: DLTs and MTD evaluated using the NCI CTCAE criteria, Version 5 Characterize safety and tolerability

Detailed description

Preliminary efficacy : CBR determined by response and stable disease rates by disease-appropriate response criteria, ORR, DoR, PFS, and OS Efficacy of OBT076 followed by balstilimab Potential re-sensitization to checkpoint inhibitors (CPI) in CPI failure patients (overall and by anti-PD-1 pre-treatment status) Efficacy of OBT076 in combination with balstilimab as determined by iORR, iDoR, iCBR, iPFS and iOS, PK Endpoints :Maximum observed plasma concentration (Cmax), area under the plasma concentration time-curve (AUC), time to maximum observed plasma concentration (Tmax), terminal half-life (t1/2)

Interventions

DRUGOBT076

DRUGRibozar 200 mg Pulver zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
safety endpoints: DLTs and MTD evaluated using the NCI CTCAE criteria, Version 5 Characterize safety and tolerability	—

Secondary

Measure	Time frame
Preliminary efficacy : CBR determined by response and stable disease rates by disease-appropriate response criteria, ORR, DoR, PFS, and OS Efficacy of OBT076 followed by balstilimab Potential re-sensitization to checkpoint inhibitors (CPI) in CPI failure patients (overall and by anti-PD-1 pre-treatment status) Efficacy of OBT076 in combination with balstilimab as determined by iORR, iDoR, iCBR, iPFS and iOS, PK Endpoints :Maximum observed plasma concentration (Cmax), area under the plasma concentration time-curve (AUC), time to maximum observed plasma concentration (Tmax), terminal half-life (t1/2)	—

Measure

Time frame

—

Countries

Belgium, France, Greece, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026