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Dose Escalation for Solid Tumors

Phase 1

Recruiting

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have been previously treated.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 1.5 years

Awards & highlights

Study Summary

This trial is studying a new drug called BGB-26808 in people with advanced solid tumors. The goal is to find the right dose of the drug and see if it works better when used alone

Who is the study for?

This trial is for adults with advanced solid tumors that can't be removed by surgery and have had prior treatment. They must have at least one measurable tumor, agree to use effective birth control, provide a tissue sample, and be in good physical condition (ECOG ≤ 1).Check my eligibility

What is being tested?

The study is testing BGB-26808 alone or combined with Tislelizumab in patients with solid tumors. It's an open-label trial aiming to find the best dose of BGB-26808.See study design

What are the potential side effects?

Possible side effects include typical reactions related to immune therapies such as fatigue, skin reactions, inflammation of organs, flu-like symptoms, and potential infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active and can carry on all pre-disease activities without restriction.

Select...

My cancer is advanced, cannot be removed by surgery, and has been treated before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808

+1 more

Secondary outcome measures

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

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

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

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment2 Interventions

Phase 1b: The recommended dose for expansion (RDFE) for BGB-26808 (alone or in combination with tislelizumab) from Phase 1a will be evaluated.

Group II: Dose EscalationExperimental Treatment2 Interventions

Phase 1a: Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tislelizumab

2018

Completed Phase 3

~4260

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor

175 Previous Clinical Trials

28,735 Total Patients Enrolled

Study DirectorStudy DirectorBeiGene

1,218 Previous Clinical Trials

499,661 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What level of risk does Dose Expansion pose to patients' safety?

"Given that this is a Phase 1 trial, there is limited data available to support the safety and effectiveness of Dose Expansion. Therefore, our team at Power rates its safety as 1 on a scale from 1 to 3."

Answered by AI

In how many different venues is this clinical trial being conducted?

"Currently, this clinical trial is underway at 5 sites. These include locations in Miranda, Kurralta Park, Nedlands, and an additional 2 undisclosed places. To minimize travel requirements for participants, it is advisable to choose a clinic nearest to your location."

Answered by AI

What is the current size of the study population participating in this clinical trial?

"To proceed with the research, a minimum of 90 eligible participants are needed. The trial will be conducted at various sites, including Southside Cancer Care in Miranda, New South Wales, and Ashford Cancer Centre Research in Kurralta Park, South Australia. BeiGene is the sponsor overseeing this study."

Answered by AI

Are participants still being enrolled for this ongoing medical study?

"Indeed, as per the information provided on clinicaltrials.gov, this study is actively seeking eligible patients. The initial posting of the trial was made on September 7th, 2023, and it was last updated on January 4th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05981703.