← Back to Search

Monoclonal Antibodies

BT8009 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

Must not have

Cohort 2: Previously Treated: Received more than 1 prior platinum-based chemotherapy regimen for locally advanced or metastatic UC. This includes neoadjuvant/adjuvant platinum-based chemotherapy if recurrence occurred within 12 months of completing therapy. Cohort 2: Prior treatment with enfortumab vedotin or any other MMAE-based therapy

Receipt of live or attenuated vaccine within 30 days of first dose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 7 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

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

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not received a live vaccine in the last 30 days.

Select...

I am not on high doses of steroids (more than 10 mg of prednisone or equivalent).

Select...

I am not taking any strong medication that affects liver enzymes or drug transporters.

Select...

I have an active eye infection or corneal ulcer.

Select...

I have not been treated with CPIs for any cancer in the last year.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Cohort 1: ORR per RECIST 1.1 assessed by BICR

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

Cohorts 1 and 2: DCR per RECIST 1.1 assessed by Investigator

+6 more