A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBolt Biotherapeutics, Inc.
About this trial
A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers
Eligibility criteria
Qualifiers
Has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
Subjects must have histologically/cytologically confirmed gastric or gastroesophageal cancer that is metastatic (Stage 4) or unresectable (Stage 3).
Subjects must have received at least 1-2 prior lines of locally available standard therapies or must be intolerant of standard therapies.
For subjects in escalation: If prior Claudin 18 IHC expression is known, the subject must have some degree of Claudin 18 expression as defined as Positive or have expression ≥ 1% of tumor cells IHC ≥ 2+. Consult with Medical Monitor as needed.
Disqualifiers
Known central nervous system (CNS) metastases except for disease that is asymptomatic, clinically stable, and has not required steroids for at least 14 days before starting study treatment.
Cardiac disease, pulmonary disease, or hepatic disease
Active infection
History of inflammatory eye disease
Trial design
Treatments tested in this trial
- BDC-4182
Treatment groups
122 Participants
are divided into 2 treatment groupsLocations
16Australia
AUS Site 2 DarlinghurstNew South Wales, Australia
AUS Site 5 WestmeadNew South Wales, Australia
AUS Site 1 BirtinyaQueensland, Australia
AUS Site 4 ClaytonVictoria, Australia
Sponsors and collaborators
Bolt Biotherapeutics, Inc.
Lead sponsor
Source ClinicalTrials.gov