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A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer

ConditionsGastric Cancer Adenocarcinoma MetastaticGastroesophageal Adenocarcinoma
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • BDC-4182

    Drug

    Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

Treatment groups

122 Participants
are divided into 2 treatment groups
Group A: Dose EscalationExperimental treatment 1 intervention
Group B: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0

Escalation period

Time frame
approximately 2 years
2

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

Secondary outcomes

1

Objective response rate (ORR) according to RECIST v. 1.1

Escalation and expansion periods

Time frame
approximately 4 years
2

Duration of Response (DOR)

Escalation and expansion periods

Time frame
approximately 4 years
3

Disease control rate (DCR)

Escalation and expansion periods

Time frame
approximately 4 years
4

Progression-free survival (PFS)

Escalation and expansion periods

Time frame
approximately 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bolt Biotherapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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