Health Trials

A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors

ConditionsAdvanced Solid TumorMetastatic Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

The goal of this clinical trial is to learn if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors.

The main questions it aims to answer are:

* What is the recommended dosing for BGB-B455? * What medical problems do participants have when taking BGB-B455?

The study has two parts:

* Phase 1a: dose escalation and safety expansion * Phase 1b: dose expansion

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed advanced or metastatic, and unresectable solid tumors who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated. Only participants with CLDN6+ high-grade OC (ie, ovarian cancer, fallopian tube cancer, or primary peritoneal cancer) will be enrolled in dose escalation cohorts, starting from Protocol Amendment 3.0.

Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central CLDN6 testing and other biomarker assessments.

Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is required for certain cohorts.

≥ 1 measurable lesion as assessed by RECIST v1.1.

Disqualifiers

Prior systemic anticancer therapy, including chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin), targeted therapy, and antibody drug conjugates (ADCs) that are standard or investigational agents (including herbal medicine or Chinese [or other country] patent medicines, ≤ 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug(s).

Palliative radiation treatment or other locoregional therapies ≤ 14 days before the first dose of study drug(s).

Live vaccine ≤ 28 days before the first dose of study drug(s). Vaccines for COVID-19 are allowed except for any live vaccine that may become available. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.

Any major surgical procedure ≤ 28 days before the first dose of study drug(s).

Trial design

Design model

Sequential

Treatments tested in this trial

  • BGB-B455

    Drug

    Planned doses administered on specified days per protocol.

  • Chemotherapy

    Drug

    Administered in accordance with relevant local guidelines and/or prescribing information.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Phase 1a: Dose Escalation and Safety ExpansionExperimental treatment 1 intervention
Group B: Phase 1b: Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase 1a: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Number of participants with AEs and SAEs, including laboratory abnormalities, and AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined adverse events of special interest (AESI) criteria.

Time frame
From the first dose of study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 7 months
2

Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B455

MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.

Time frame
Approximately 1 month
3

Phase 1a: RDFE of BGB-B455

RDFE of BGB-B455 will be determined based upon the MTD or MAD.

Time frame
Approximately 1 month
4

Phase 1b: Overall Response Rate (ORR)

ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as determined from tumor assessments by investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR and PR must be confirmed by repeat assessments.

Time frame
Approximately 18 months

Secondary outcomes

1

Phase 1a: ORR

ORR is defined as the percentage of participants with best overall response of CR or PR, as determined from tumor assessments by investigator per RECIST v1.1. CR and PR must be confirmed by repeat assessments.

Time frame
Approximately 18 months
2

Phase 1a and 1b: Duration of Response (DOR)

DOR is defined as the time from the first confirmed objective response to documented disease progression or death, whichever occurs first, as determined from tumor assessments by investigator per RECIST v1.1.

Time frame
Approximately 18 months
3

Phase 1a and 1b: Disease Control Rate (DCR)

DCR is defined as the percentage of participants who achieve CR, PR, or stable disease, as determined from tumor assessments by investigator per RECIST v1.1.

Time frame
Approximately 18 months
4

Phase 1a and 1b: Time to Response (TTR)

TTR is defined as the time from the date of the first administration of study drug to the first confirmed response, as determined from tumor assessments by investigator per RECIST v1.1.

Time frame
Approximately 18 months

Other outcomes

Sponsors and contacts

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

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov
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