Gastric Cancer Adenocarcinoma Metastatic, Gastroesophageal Adenocarcinoma
Conditions
Keywords
Gastric Cancer, Gastroesophageal Cancer
Brief summary
A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers
Detailed description
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.
Interventions
DRUGBDC-4182
Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
Sponsors
Bolt Biotherapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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. * Adequate organ function * Agree to have a biopsy prior to enrollment, at acceptable risk in the judgement of the Investigator. If a biopsy is not safely accessible or clinically feasible, an adequate archival tumor sample must be submitted. Key
Exclusion criteria
* 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 * Residual toxicity from a previous treatment * Any investigational agent or standard anti-cancer therapies within 28 days before starting study treatment or within 5 estimated elimination half-lives, whichever is shorter.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0 | approximately 2 years | Escalation period |
| 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 | Up to 21 days | Escalation period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) according to RECIST v. 1.1 | approximately 4 years | Escalation and expansion periods |
| Duration of Response (DOR) | approximately 4 years | Escalation and expansion periods |
| Disease control rate (DCR) | approximately 4 years | Escalation and expansion periods |
| Progression-free survival (PFS) | approximately 4 years | Escalation and expansion periods |
| Best Overall Response (BOR) | approximately 4 years | Escalation and expansion periods |
| Overall survival (OS) | approximately 4 years | Escalation and expansion periods |
| PK (Cmax) of BDC-4182 | approximately 4 years | Escalation and expansion periods |
| PK (Cmin) of BDC-4182 | approximately 4 years | Escalation and expansion periods |
| PK (AUC0-tau) of BDC-4182 | approximately 4 years | Escalation and expansion periods |
| PK (AUC0-inf) of BDC-4182 | approximately 4 years | Escalation and expansion periods |
| PK (CL) of BDC-4182 | approximately 4 years | Escalation and expansion periods |
| PK (Vc or Vss) of BDC-4182 | approximately 4 years | Escalation and expansion periods |
| PK (Terminal half-life) of BDC-4182 | approximately 4 years | Escalation and expansion periods |
Countries
Australia, South Korea, Taiwan
Contacts
CONTACTBolt Biotherapeutics
STUDY_DIRECTORBolt Clinical Development
Bolt Biotherapeutics
Outcome results
None listed