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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or death or up to 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks for the first 12 months then every 12 weeks until death, then every 3 months for up to 1 year after last patient accrued
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks for the first 12 months then every 12 weeks until death, then every 3 months for up to 1 year after last patient accrued for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part B (all Cohorts): 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
+4 more
Secondary outcome measures
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

Trial Design

11Treatment 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 A-2 -BT8009 in Combination with Pembrolizumab Dose De-EscalationExperimental Treatment2 Interventions
Participants will receive BT8009 and a standard dose of pembrolizumab.
Group IV: Part A-1 -BT8009 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants will receive escalating doses of BT8009 via IV.
Group V: 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 VI: Cohort B-6- BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Group VII: Cohort B-5- BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Group VIII: Cohort B-4- BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Group IX: Cohort B-3- BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009. .
Group X: Cohort B-2- BT8009 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants will receive a selected dose of BT8009.
Group XI: 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 2
~2010

Find a Location

Who is running the clinical trial?

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

Media Library

BT8009 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04561362 — Phase 1 & 2
Ovarian Neoplasms Research Study Groups: 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
Ovarian Neoplasms 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

Frequently Asked Questions

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

Has BT8009 been the focus of other investigations within a clinical setting?

"BT8009, which was initially researched in 2012 at Local Institution, now has a total of 421 completed studies. Currently, there are 718 active trials centered around this medication - many of these being held in Louisville Kentucky."

Answered by AI

How many participants have signed up for the research project thus far?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical study which was first listed on July 17th 2020 is still recruiting patients. To meet its goal of 329 participants, 10 sites need to contribute volunteers."

Answered by AI

Is this investigation a groundbreaking endeavor?

"BT8009 has been under clinical scrutiny since 2012. Ono Pharmaceutical Co. Ltd initially sponsored a trial that included 659 participants, and the drug was later approved after Phase 1 & 2 trials were completed. Currently, BT8009 is being trialled in 2356 cities across 49 countries with 718 active studies taking place."

Answered by AI

To what extent are hospitals involved in this investigation?

"Currently, this medical trial is being administered from 10 different clinics across North America. These include Louisville, Toronto and Denver; among others. To minimise inconvenience for potential participants it is recommended to select the closest clinic to you when considering enrolment."

Answered by AI

Is there room to enroll more participants in this clinical experiment?

"According to the information found on clinicaltrials.gov, this medical study has opened its recruitment process and is actively seeking participants. The trail was first posted on July 17th 2020 and most recently updated November 22nd 2021."

Answered by AI

What medical conditions has BT8009 been clinically proven to be an effective remedy for?

"BT8009 is commonly used to treat malignant neoplasms, but it has also been known to reduce the severity of unresectable melanomas, squamous cell carcinomas and metastatic esophageal adenocarcinoma."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
The University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies
2020. "Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04561362.
All > Non Small Cell Lung Cancer > Bladder Cancer
~98 spots leftby Dec 2025
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