A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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.
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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1PHASE2
Study ID
NCT06921837
Intervention or treatment
DRUG: BDC-4182
Conditions
- Gastric Cancer Adenocarcinoma Metastatic
- Gastroesophageal Adenocarcinoma
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
AUS Site 2
Select from list below to view details:
AUS Site 2
Darlinghurst, New South Wales, Australia
AUS Site 1
Birtinya, Queensland, Australia
AUS Site 3
Heidelberg, Victoria, Australia
Loading map...
Who is running the clinical trial?
Bolt Biotherapeutics, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Dose Escalation
| Drug: BDC-4182 |
EXPERIMENTAL: Dose Expansion
| Drug: BDC-4182 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0 | Escalation period | 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 | Up to 21 days |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) according to RECIST v. 1.1 | Escalation and expansion periods | approximately 4 years |
| Duration of Response (DOR) | Escalation and expansion periods | approximately 4 years |
| Disease control rate (DCR) | Escalation and expansion periods | approximately 4 years |
| Progression-free survival (PFS) | Escalation and expansion periods | approximately 4 years |
| Best Overall Response (BOR) | Escalation and expansion periods | approximately 4 years |
| Overall survival (OS) | Escalation and expansion periods | approximately 4 years |
| PK (Cmax) of BDC-4182 | Escalation and expansion periods | approximately 4 years |
| PK (Cmin) of BDC-4182 | Escalation and expansion periods | approximately 4 years |
| PK (AUC0-tau) of BDC-4182 | Escalation and expansion periods | approximately 4 years |
| PK (AUC0-inf) of BDC-4182 | Escalation and expansion periods | approximately 4 years |
| PK (CL) of BDC-4182 | Escalation and expansion periods | approximately 4 years |
| PK (Vc or Vss) of BDC-4182 | Escalation and expansion periods | approximately 4 years |
| PK (Terminal half-life) of BDC-4182 | Escalation and expansion periods | approximately 4 years |
References
Clinical Trials Gov: A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal CancerOther trials to consider
Loading suggested trials...
