A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers
This is a dose escalation study designed to evaluate the safety and tolerability of BDC-4182 to establish the recommended Phase 2 dose (RP2D). Participants will be enrolled in each dose cohort until the maximum tolerated dose (MTD) is reached. Additional participants may be enrolled into backfill cohorts at dose levels that have been cleared to collect additional safety and tolerability data. Additional participants may be enrolled at the determined RP2D in an expansion portion of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
AUS Site 2
Darlinghurst, New South Wales, Australia
RECRUITINGAUS Site 5
Westmead, New South Wales, Australia
RECRUITINGIncidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0
Escalation period
Time frame: approximately 2 years
Incidence and nature of AEs considered by the Investigator or Sponsor to be clinically relevant, attributable to study treatment, and meeting dose-limiting toxicity (DLT) criteria
Escalation period
Time frame: Up to 21 days
Objective response rate (ORR) according to RECIST v. 1.1
Escalation and expansion periods
Time frame: approximately 4 years
Duration of Response (DOR)
Escalation and expansion periods
Time frame: approximately 4 years
Disease control rate (DCR)
Escalation and expansion periods
Time frame: approximately 4 years
Progression-free survival (PFS)
Escalation and expansion periods
Time frame: approximately 4 years
Best Overall Response (BOR)
Escalation and expansion periods
Time frame: approximately 4 years
Overall survival (OS)
Escalation and expansion periods
Time frame: approximately 4 years
PK (Cmax) of BDC-4182
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUS Site 1
Birtinya, Queensland, Australia
RECRUITINGAUS Site 4
Clayton, Victoria, Australia
RECRUITINGAUS Site 3
Heidelberg, Victoria, Australia
RECRUITINGSK Site 2003
Seongnam-si, South Korea
RECRUITINGSK Site 2001
Seoul, South Korea
RECRUITINGSK Site 2002
Seoul, South Korea
RECRUITINGSK Site 2004
Seoul, South Korea
RECRUITINGSK Site 2005
Seoul, South Korea
RECRUITING...and 6 more locations
Escalation and expansion periods
Time frame: approximately 4 years
PK (Cmin) of BDC-4182
Escalation and expansion periods
Time frame: approximately 4 years
PK (AUC0-tau) of BDC-4182
Escalation and expansion periods
Time frame: approximately 4 years
PK (AUC0-inf) of BDC-4182
Escalation and expansion periods
Time frame: approximately 4 years
PK (CL) of BDC-4182
Escalation and expansion periods
Time frame: approximately 4 years
PK (Vc or Vss) of BDC-4182
Escalation and expansion periods
Time frame: approximately 4 years
PK (Terminal half-life) of BDC-4182
Escalation and expansion periods
Time frame: approximately 4 years