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Monoclonal Antibodies

BT8009 + Pembrolizumab for Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by Bicycle Tx Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort B-4: Patients with histologically confirmed non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer that is Stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria that have progressed following prior therapy
Cohort B-2 and B-3: Histologically documented urothelial carcinoma, not previously treated with enfortumab vedotin (EV). Patients with resectable, locally advanced urothelial carcinoma are ineligible. Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy
Must not have
Known active or untreated CNS and/or carcinomatous meningitis
Active systemic infection requiring therapy, or fever within the last 14 days prior to first dose of BT8009
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from cycle 1 day 1 until at least 30 days after the end of treatment (each cycle is 21 or 28 days depending on the assigned dosing schedule)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called BT8009, either alone or combined with another drug called nivolumab, in people with advanced solid tumors. The goal is to see if it is safe and effective.

Who is the study for?
This trial is for adults with advanced cancers like ovarian, breast, lung, and bladder cancer that express Nectin-4. Participants must have tried all standard treatments without success or be unsuitable for them. They should not have had certain other cancers in the last 3 years or conditions like uncontrolled diabetes, active infections, severe nerve damage, or a history of serious skin reactions to similar drugs.
What is being tested?
The study tests BT8009 alone and combined with Pembrolizumab in patients whose tumors show Nectin-4 expression. It's an early-phase trial to find safe doses (Phase I) and then see how well it works (Phase II). The main goals are to check for dose-limiting side effects and measure tumor response rates.
What are the potential side effects?
Possible side effects include allergic reactions to the treatment infusion, organ inflammation due to immune system activation by Pembrolizumab, blood sugar control issues which could worsen diabetes if already present, potential worsening of nerve damage in hands and feet (neuropathy), among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced ovarian, fallopian tube, or peritoneal cancer that has worsened after treatment.
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My bladder cancer has worsened or returned after my last treatment and I haven't been treated with EV.
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My bladder cancer has worsened after treatment.
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My NSCLC has no targetable mutations and has worsened after treatment.
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My bladder cancer has come back or didn't respond to treatment, and I can provide a biopsy.
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I have tried all standard treatments without success, or no standard treatment is suitable for me.
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My advanced cancer is Nectin-4 positive and has worsened after at least one treatment.
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I have tried all standard treatments for my condition, or no standard treatment is suitable for me.
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My bladder cancer has worsened after treatment with enfortumab vedotin.
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My cancer has returned or didn't respond to treatment and tests positive for Nectin-4.
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It seems like the criterion you've mentioned is incomplete. Could you please provide more details or context so that I can assist you accurately?
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My breast cancer is triple-negative and has worsened after previous treatments.
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I have advanced bladder cancer and haven't had treatments for it, and can't take cisplatin.
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My cancer has returned or didn't respond to treatment and it's one of the specified types.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active or untreated brain or spinal cord cancer.
Select...
I have not had a fever or needed treatment for an infection in the last 14 days.
Select...
I have moderate to severe numbness, pain, or weakness in my hands or feet.
Select...
My diabetes is not under control.
Select...
I have previously been treated with enfortumab vedotin.
Select...
I have had an organ transplant.
Select...
I have a history of lung scarring or fibrosis.
Select...
I have an active eye infection or corneal ulcer.
Select...
My blood pressure is not controlled by medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from cycle 1 day 1 until at least 30 days after the end of treatment (each cycle is 21 or 28 days depending on the assigned dosing schedule)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from cycle 1 day 1 until at least 30 days after the end of treatment (each cycle is 21 or 28 days depending on the assigned dosing schedule) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part B1-B7: Objective response rate (ORR) to assess the clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab using RECIST 1.1.
Part D: Area under the plasma concentration-time curve (AUC) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy
Part D: Elimination half-life (t1/2) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy
+5 more
Secondary study objectives
All cohorts: Number of participants positive for anti-drug antibodies (ADA) to determine incidence of ADA
Cohorts B-4, B-5, and B-6: Objective response rate by Nectin-4 status of BT8009 as a monotherapy in patients with selected solid tumor using RECIST 1.1.
Part A, B and C: Area under the plasma concentration-time curve (AUC) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy and in combination with pembrolizumab.
+18 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

13Treatment groups
Experimental Treatment
Group I: Part D - BT8009 Monotherapy Supplementary PKExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Group II: Part C - Renal Insufficiency BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Group III: Part B-9 - BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Group IV: Part B-8 - BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Group V: Part A-2 -BT8009 in Combination with Pembrolizumab Dose De-EscalationExperimental Treatment2 Interventions
Participants will receive BT8009 and a standard dose of pembrolizumab.
Group VI: Part A-1 -BT8009 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants will receive escalating doses of BT8009 via IV.
Group VII: Cohort B-7- BT8009 in Combination with Pembrolizumab Dose ExpansionExperimental Treatment2 Interventions
Participants will receive a selected dose of BT8009 and standard dose of pembrolizumab.
Group VIII: Cohort B-6- BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Group IX: Cohort B-5- BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Group X: Cohort B-4- BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Group XI: Cohort B-3- BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009. .
Group XII: Cohort B-2- BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Group XIII: Cohort B-1 - BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

Bicycle Tx LimitedLead Sponsor
1 Previous Clinical Trials
288 Total Patients Enrolled
BicycleTx LimitedLead Sponsor
3 Previous Clinical Trials
1,444 Total Patients Enrolled
Meredith McKean, MD, MPHStudy ChairTennessee Oncology, PLLC
1 Previous Clinical Trials
288 Total Patients Enrolled

Media Library

BT8009 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04561362 — Phase 1 & 2
Breast Cancer Research Study Groups: Part B-8 - BT8009 Monotherapy Dose Expansion, Part B-9 - BT8009 Monotherapy Dose Expansion, Cohort B-5- BT8009 Monotherapy Dose Expansion, Part C - Renal Insufficiency BT8009 Monotherapy Dose Expansion, Cohort B-4- BT8009 Monotherapy Dose Expansion, Part A-2 -BT8009 in Combination with Pembrolizumab Dose De-Escalation, Part A-1 -BT8009 Monotherapy Dose Escalation, Cohort B-3- BT8009 Monotherapy Dose Expansion, Part D - BT8009 Monotherapy Supplementary PK, Cohort B-1 - BT8009 Monotherapy Dose Expansion, Cohort B-2- BT8009 Monotherapy Dose Expansion, Cohort B-6- BT8009 Monotherapy Dose Expansion, Cohort B-7- BT8009 in Combination with Pembrolizumab Dose Expansion
Breast Cancer Clinical Trial 2023: BT8009 Highlights & Side Effects. Trial Name: NCT04561362 — Phase 1 & 2
BT8009 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04561362 — Phase 1 & 2
~104 spots leftby Dec 2026
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