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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years and 11 months
Awards & highlights
Study Summary
This trial studies the safety and effectiveness of a new drug to treat advanced or metastatic solid tumors. It will test different doses and combinations.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors, including various cancer types like lung, liver, breast, and more. Participants must have tried standard treatments without success or be unable to tolerate them. They should have at least one measurable tumor and be in good physical condition (ECOG score ≤ 1). Women who can bear children must use effective birth control during the study.Check my eligibility
What is being tested?
The trial tests BGB-30813 alone and combined with tislelizumab to assess safety and early cancer-fighting effects. It's a two-part study: first finding the right dose (Phase 1a) then expanding that dose to more patients (Phase 1b) among those with specific types of solid tumors.See study design
What are the potential side effects?
Possible side effects include typical reactions related to immune therapies such as fatigue, skin reactions, digestive issues, changes in blood counts or liver enzymes which will be closely monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years and 11 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years and 11 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1a : Dose Escalation: The Maximum Tolerated Dose (MTD) and Maximum Administered Dose (MAD) and Recommended dose(s) for Expansion (RDFE[s]) of BGB-30813 Alone or in Combination with Tislelizumab
Phase 1a: Dose Escalation: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Dose-Limiting Toxicities (DLTs)
Phase 1b: Dose Expansion: Overall Response Rate (ORR) as Determined by the Investigator
Secondary outcome measures
Phase 1a: Dose Escalation: Area Under the concentration-time curve (AUC) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Phase 1a: Dose Escalation: Half-life (t1/2) Of BGB-30813 and Metabolite BGB-33481 Alone and in Combination with Tislelizumab
Phase 1a: Dose Escalation: ORR as Determined by the Investigator
+7 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Phase 1b: Dose Expansion BGB-30813 in Combination with TislelizumabExperimental Treatment2 Interventions
Group II: Phase 1a: Dose Escalation Part B: BGB-30813 + TislelizumabExperimental Treatment2 Interventions
Group III: Phase 1a: Dose Escalation Part A: BGB-30813 MonotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4260
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,616 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had treatments targeting DGK.I do not have active brain or spinal cord tumor spread that is causing symptoms.I haven't had cancer treatment in the last 3 weeks or 5 half-lives of the drug.I haven't had any cancer other than the one being studied in the last 2 years.I have an advanced cancer that cannot be surgically removed and have not been treated with DGK-targeting therapy.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What degree of harm could be posed to participants in Phase 1a: Dose Escalation Part A: BGB-30813 Monotherapy?
"Our team at Power estimated that Phase 1a: Dose Escalation Part A: BGB-30813 Monotherapy has a safety rating of 1 due to the paucity of clinical data supporting both efficacy and safety."
Answered by AI
How many regional sites are actively managing this research?
"Presently, the clinical trial is being administrated in 11 distinct sites. These locations range from Houston to Clayton and even include San Antonio. In order to minimize travel needs, it would be prudent for patients to select a clinic close by them before enrolling."
Answered by AI
Is enrollment for this trial actively open at present?
"According to clinicaltrials.gov, this medical trial is not presently looking for participants. Although it was initially posted on the 1st of July 2023 and last updated 6th June 2023, there are 514 other studies currently seeking enrolment."
Answered by AI
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