BGB-A445 for Phase 1 Clinical Trials for Advanced Solid Tumors, Non-Small Cell Lung Cancer, and Head and Neck Squamous Cell Carcinoma.

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Phase 1 Clinical Trials for Advanced Solid Tumors, Non-Small Cell Lung Cancer, and Head and Neck Squamous Cell Carcinoma.+1 MoreBGB-A445 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it is safe and works well when used alone or with another cancer drug.

Eligible Conditions
  • Phase 1 Clinical Trials for Advanced Solid Tumors, Non-Small Cell Lung Cancer, and Head and Neck Squamous Cell Carcinoma.
  • Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

10 Primary · 30 Secondary · Reporting Duration: 60 minutes predose up to 72 hours postdose

Day 21
Phase 1a: Area Under the Concentration-Time Curve of 0-21 Days (AUC0-21d) of BGB-A445
Phase 1b: Area Under the Concentration-Time Curve of 0-21 Days (AUC0-21d) of BGB-A445
Hour 72
Phase 1a: Maximum Observed Plasma Concentration (Cmax) of BGB-A445
Phase 1a: Maximum Observed Plasma Concentration (Cmax) of tislelizumab
Phase 1a: Minimum Observed Plasma Concentration (Cmin) of BGB-A445
Phase 1a: Minimum Observed Plasma Concentration (Cmin) of tislelizumab
Phase 1a: Serum Concentration of BGB-A445
Phase 1a: Serum Concentration of tislelizumab
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of BGB-A445
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of tislelizumab
Phase 1b: Maximum Observed Plasma Concentration (Cmax) of BGB-A445
Phase 1b: Maximum Observed Plasma Concentration (Cmax) of tislelizumab
Phase 1b: Minimum Observed Plasma Concentration (Cmin) of BGB-A445
Phase 1b: Minimum Observed Plasma Concentration (Cmin) of tislelizumab
Phase 1b: Serum Concentration of BGB-A445
Phase 1b: Serum Concentration of tislelizumab
Phase 1b: Time to Maximum Plasma Concentration (Tmax) of BGB-A445
Phase 1b: Time to Maximum Plasma Concentration (Tmax) of tislelizumab
Day 30
Maximum RP2D of BGB-A445 when Administered Alone
Maximum RP2D of BGB-A445 when Administered in Combination with Tislelizumab
Overall Response Rate (ORR) as Assessed by the Investigator
Phase 1a: Disease-Control Rate (DCR) as Assessed by the Investigator
Phase 1a: Duration of Response (DOR) as Assessed by the Investigator
Phase 1a: Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies
Phase 1a: Immunogenic Responses to tislelizumab as assessed through the detection of antidrug antibodies
Phase 1a: Maximum Tolerated Dose (MTD) of BGB-A445
Phase 1a: Overall Response Rate (ORR) as Assessed by the Investigator
Phase 1b: Disease-Control Rate (DCR) as Assessed by the Investigator
Phase 1b: Duration of Response (DOR) as Assessed by the Investigator
Phase 1b: Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies
Phase 1b: Immunogenic Responses to tislelizumab as assessed through the detection of antidrug antibodies
Phase 1b: Overall Response Rate (ORR) as Assessed by the Investigator
Phase 1b: Progression-free survival (PFS) as Assessed by the Investigator
Phase 1b: RP2D of BGB-A445 when Administered Alone
Day 90
Phase 1a: Number of Participants Experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
Phase 1a: number of Participants Experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria
Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
Phase 1b: Number of Participants Experiencing Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

1 of 3

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Trial Design

5 Treatment Groups

Phase 1b: BGB-A445 + Tislelizumab Combination Therapy
1 of 5
Phase 1b:BGB-A445 Monotherapy or Combination with Tislelizumab
1 of 5
Phase 1b:BGB-A445 Monotherapy
1 of 5
Phase 1a: BGB-A445 Monotherapy
1 of 5
Phase 1a: BGB-A445 + Tislelizumab Combination Therapy
1 of 5

Experimental Treatment

360 Total Participants · 5 Treatment Groups

Primary Treatment: BGB-A445 · No Placebo Group · Phase 1

Phase 1b: BGB-A445 + Tislelizumab Combination TherapyExperimental Group · 2 Interventions: BGB-A445, tislelizumab · Intervention Types: Drug, Drug
Phase 1b:BGB-A445 Monotherapy or Combination with TislelizumabExperimental Group · 2 Interventions: BGB-A445, tislelizumab · Intervention Types: Drug, Drug
Phase 1b:BGB-A445 Monotherapy
Drug
Experimental Group · 1 Intervention: BGB-A445 · Intervention Types: Drug
Phase 1a: BGB-A445 Monotherapy
Drug
Experimental Group · 1 Intervention: BGB-A445 · Intervention Types: Drug
Phase 1a: BGB-A445 + Tislelizumab Combination TherapyExperimental Group · 2 Interventions: BGB-A445, tislelizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 60 minutes predose up to 72 hours postdose

Who is running the clinical trial?

BeiGeneLead Sponsor
147 Previous Clinical Trials
26,393 Total Patients Enrolled
Katie WoodStudy DirectorBeiGene
2 Previous Clinical Trials
130 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,068 Previous Clinical Trials
475,039 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell cancer whose tumor is not amenable to local therapy with curative intent (ie.
The patient's vital signs, physical examination, and laboratory values are normal.
You have at least 1 measurable lesion as defined per RECIST 1.1.
Participants must be able to provide an archived formalin fixed paraffin embedded (FFPE) tumor tissue sample (block or approximately 15 freshly unstained FFPE slides) after the most recent line of therapy.