Clinical trial NCT06921837: A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
Official title: A Phase 1/2, First-in-Human, Dose Escalation and Expansion Study of BDC-4182 as a Single Agent in Patients With Advanced Gastric and Gastroesophageal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer Adenocarcinoma Metastatic
Gastroesophageal Adenocarcinoma
Keywords: Gastric Cancer
Gastroesophageal Cancer
Lead sponsor: Bolt Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-10
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0
timeFrame: approximately 2 years
measure: 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
timeFrame: Up to 21 days
Secondary outcomes:
measure: Objective response rate (ORR) according to RECIST v. 1.1
timeFrame: approximately 4 years
measure: Duration of Response (DOR)
timeFrame: approximately 4 years
measure: Disease control rate (DCR)
timeFrame: approximately 4 years
measure: Progression-free survival (PFS)
timeFrame: approximately 4 years
measure: Best Overall Response (BOR)
timeFrame: approximately 4 years
measure: Overall survival (OS)
timeFrame: approximately 4 years
measure: PK (Cmax) of BDC-4182
timeFrame: approximately 4 years
measure: PK (Cmin) of BDC-4182
timeFrame: approximately 4 years
measure: PK (AUC0-tau) of BDC-4182
timeFrame: approximately 4 years
measure: PK (AUC0-inf) of BDC-4182
timeFrame: approximately 4 years
measure: PK (CL) of BDC-4182
timeFrame: approximately 4 years
measure: PK (Vc or Vss) of BDC-4182
timeFrame: approximately 4 years
measure: PK (Terminal half-life) of BDC-4182
timeFrame: approximately 4 years
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: AUS Site 2
state: New South Wales
city: Birtinya
country: Australia
facility: AUS Site 1
state: Queensland
Study officials:
affiliation: Bolt Biotherapeutics
name: Bolt Clinical Development
role: STUDY_DIRECTOR
References: