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Monoclonal Antibodies

Cohort 1: BT8009 Arm1 for Bladder Cancer

Phase 2 & 3

Recruiting

Research Sponsored by BicycleTx Limited

Eligibility Criteria Checklist

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

Must have

Cohort 1: Previously Untreated: Eligible to receive platinum-based chemotherapy (either cisplatin- or carboplatin-based chemotherapy based on Investigator decision)

Histologically or cytologically confirmed locally advanced (unresectable) or metastatic UC of the renal pelvis, ureter, bladder, or urethra

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 7 years

Awards & highlights

Study Summary

This trial is being conducted in multiple locations worldwide and aims to test the effectiveness and safety of a drug called BT8009. The drug will be tested on individuals with advanced or spreading urothelial

Who is the study for?

This trial is for adults with advanced bladder cancer. Cohort 1 includes those who haven't had systemic therapy and can get platinum-based chemo, while Cohort 2 has had at least one systemic treatment. Key eligibility details are not provided.Check my eligibility

What is being tested?

The study tests BT8009 alone and combined with pembrolizumab against standard chemo (gemcitabine plus cisplatin or carboplatin) in two groups of patients based on prior treatments. It's a global study with an adaptive design to evaluate effectiveness and safety.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions, infusion responses, fatigue, nausea from chemotherapy drugs like gemcitabine and cisplatin/carboplatin, as well as any specific effects related to the new drug BT8009.

Eligibility Criteria

Inclusion Criteria

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

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I am eligible for and have not received platinum-based chemotherapy.

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My cancer originates from the urinary system and cannot be surgically removed or has spread.

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I can provide a recent or stored tissue sample of my cancer for testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 7 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

Cohort 1: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) assessed by blinded central independent review (BICR)

Cohort 2: Objective response rate (ORR) per RECIST 1.1 assessed by BICR

Secondary outcome measures

Cohort 1: ORR per RECIST 1.1 assessed by BICR

Cohort 2: PFS per RECIST v1.1 assessed by BICR

Cohorts 1 and 2: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

+12 more

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 2: BT8009 Arm 2Experimental Treatment1 Intervention

Participants will receive IV dose of BT8009.

Group II: Cohort 2: BT8009 Arm 1Experimental Treatment1 Intervention

Participants will receive IV dose of BT8009.

Group III: Cohort 2: Arm 3: BT8009 (Not Recruiting)Experimental Treatment2 Interventions

Participants will receive BT8009 and a standard dose of pembrolizumab.

Group IV: Cohort 1: BT8009 Arm1Experimental Treatment2 Interventions

Participants will receive BT8009 and a standard dose of pembrolizumab.

Group V: Cohort 1: BT8009 Arm 2Experimental Treatment2 Interventions

Participants will receive BT8009 and a standard dose of pembrolizumab.

Group VI: Cohort 1:Arm 3:Participants receiving Platinum-based combination chemotherapy + avelumab maintenanceActive Control2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

BicycleTx LimitedLead Sponsor

3 Previous Clinical Trials

817 Total Patients Enrolled

Frequently Asked Questions

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

Are participants currently being recruited for this research study?

"Indeed, the information provided on clinicaltrials.gov indicates that this research study is presently seeking individuals to participate. The trial was originally posted on January 24th, 2024 and was most recently updated on the same day. A total of 956 patients are sought for enrollment at a single site."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical research study?

"Indeed, the information provided on clinicaltrials.gov confirms that this clinical trial is actively seeking eligible participants. The initial posting date of the trial was January 24th, 2024 and it has been recently updated as of the same day. Recruitment aims to enroll a total of 956 patients from a single designated location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

2024. "Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06225596.

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