NCT06921837 A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer
| NCT ID | NCT06921837 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Bolt Biotherapeutics, Inc. |
| Condition | Gastric Cancer Adenocarcinoma Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 122 participants |
| Start Date | 2025-05-26 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 122 participants in total. It began in 2025-05-26 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers
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.
Contact & Investigator
Bolt Clinical Development
STUDY DIRECTOR
Bolt Biotherapeutics
Frequently Asked Questions
Who can join the NCT06921837 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Cancer Adenocarcinoma Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06921837 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06921837 currently recruiting?
Yes, NCT06921837 is actively recruiting participants. Contact the research team at clinicaltrials@boltbio.com for enrollment information.
Where is the NCT06921837 trial being conducted?
This trial is being conducted at Darlinghurst, Australia, Westmead, Australia, Birtinya, Australia, Clayton, Australia and 11 additional locations.
Who is sponsoring the NCT06921837 clinical trial?
NCT06921837 is sponsored by Bolt Biotherapeutics, Inc.. The principal investigator is Bolt Clinical Development at Bolt Biotherapeutics. The trial plans to enroll 122 participants.
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