Health Trials

A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors

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

About this trial

This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.

Phase 1a: Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have previously received standard systemic therapy, or for whom treatment is not available or not tolerated, or for whom treatment is determined not appropriate based on investigator's judgment and who have not received prior therapy targeting hematopoietic progenitor kinase 1 (HPK1).

Phase 1b: Participants with histologically confirmed locally advanced unresectable or metastatic tumor types and who have not had prior systemic treatment. Participants who received prior systemic therapy in a neo-adjuvant or adjuvant setting with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of systemic therapy prior to the first dose of study treatments.

Disqualifiers

Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-CTLA4, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.

Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.

Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).

Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BGB-26808

    Drug

    Planned doses administered orally as a tablet daily.

  • Tislelizumab

    Drug

    Planned doses administered by intravenous infusion.

  • Chemotherapy

    Drug

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

Treatment groups

337 Participants
are divided into 2 treatment groups
Group A: Phase 1a: Dose EscalationExperimental treatment 2 interventions
Group B: Phase 1b: Dose ExpansionExperimental treatment 3 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 findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.

Time frame
From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
2

Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808

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: Recommended Dose for Expansion (RDFE) of BGB-26808

RDFE of BGB-26808 alone or in combination with tislelizumab 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 who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Time frame
Approximately 6 months

Secondary outcomes

1

Phase 1a: ORR

ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.

Time frame
Approximately 6 months
2

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

DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.

Time frame
Approximately 9 months
3

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

DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease. It will be summarized similarly as ORR as assessed by the investigator.

Time frame
Approximately 6 months
4

Phase 1a and 1b: Clinical Benefit Rate (CBR)

CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigator.

Time frame
Approximately 6 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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