Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Carboplatin

Pembrolizumab

Avelumab

Cisplatin

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants will receive BT8009 and a standard dose of pembrolizumab.

Participants will receive Platinum-based combination chemotherapy +/- avelumab maintenance

Participants will receive BT8009 on Days 1, 8, and 15 of every 21-day cycle.

BT8009

Participants will receive BT8009 on Days 1 and 8 of every 21-day cycle.

Participants will receive BT8009 on days 1, 8 +/- 15 schedule of every 21-day cycle.

Participants will receive Pembrolizumab on Day 1 of every 21-day cycle. Pembrolizumab infusion will be started 30 minutes following the completion of the BT8009 infusion.

Participants will receive Gemcitabine on Days 1 and 8 of every 21-day cycle plus cisplatin Or carboplatin on Day 1 of every 21-day cycle.

Gemcitabine + cisplatin Or carboplatin

After 4-6 cycles of Gemcitabine + Cisplatin or Carboplatin participants will receive maintenance Avelumab, if clinically indicated, on Days 1 and 15 each 28-day cycle.

BicycleTx Limited

This is a global, multicenter, randomized, open-label study, with an adaptive design. The main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide pevedotin) as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection phase followed by an adaptive design continuation. The study is comprised of 2 cohorts. Cohort 1 will include participants who have not received any prior systemic therapy for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy, whereas Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC.

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

A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

The time from randomization to date of first documentation of disease progression or death.

The time from randomization to date of death from any cause.

The time from time of first documentation of objective response that is subsequently confirmed to date of first documentation of objective tumor progression or death.

The time from Cycle 1 Day 1 to date of first documentation of disease progression or death

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Ovarian Neoplasms

Renal Insufficiency

Carcinoma, Transitional Cell

Breast Diseases

Skin Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Ovarian Cancer

Transitional Cell Carcinoma

Participants will receive escalating doses of BT8009 via IV.

Participants will receive a selected dose of BT8009.

Participants will receive a selected dose of BT8009. .

Participants will receive a selected dose of BT8009 and standard dose of pembrolizumab.

Bicyclic Toxin Conjugate (BTC) administered either weekly (i.e., on Days 1, 8, 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle for participants in A-1. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1,8 and 15 of a 21-day cycle. Participants in Part B will receive BT8009 once weekly either on a 21-day or 28-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, 15, and 22) on a 28-day cycle. Participants in Part D will receive BT8009 once weekly on a 28-day cycle.

Participants in Cohorts A-2 and B-7 will receive 200 mg IV over 30-minute infusion of pembrolizumab on Day 1 of each Q3W.

Bicycle Tx Limited

Meredith McKean, MD, MPH

This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are: Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Part B), Safety and tolerability (Part C), and characterization of the pharmacokinetics (Part D).

This study will assess the safety and tolerability of BT8009 alone and in combination with pembrolizumab in patients with select advanced solid tumors. BT8009 will be given as a single agent in 3 different dosing schedules- weekly (28 day cycle), biweekly (28 day cycle) or dosing on day 1 and day 8 of a 3-weekly (21 day cycle) and in combination with pembrolizumab. There are three parts to this study. Part A is a dose escalation in patients with select advanced solid tumors primarily designed to evaluate safety and tolerability of BT8009 as monotherapy or in combination with pembrolizumab and to determine a recommended Phase II dose (RP2D). Following a selection of an RP2D, Part B, a dose expansion portion, will be initiated with the primary objective of clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab in patients with select advanced solid tumors. Part C will evaluate safety and tolerability of RP2D in patients with renal insufficiency. Part D will further characterize the pharmacokinetics of BT8009 and MMAE.

Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies

Safety reported as incidence of treatment-emergent adverse events using CTCAE v5.0 criteria.

Number of patients who experience dose limiting toxicities BT8009 when given as a monotherapy or in combination with pembrolizumab.

Proportion of participants with confirmed complete response or partial response to BT8009 as a monotherapy or in combination with pembrolizumab according to RECIST 1.1 criteria.

Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone.

Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone

Number of participants with advanced solid tumor malignancies associated with Nectin-4 expression receiving BT8009 as a monotherapy or in combination with pembrolizumab who experience treatment-emergent adverse events using CTCAE v5.0 criteria.

Duration of objective response (complete or partial response) by RECIST 1.1 in participants receiving BT8009 as a monotherapy or in combination with pembrolizumab

Proportion of participants who have complete response (CR), partial response (PR), or stable disease (SD) for at least 16 weeks according to RECIST Version 1.1 criteria.

The time from the first day of study drug administration (Day 1) to disease progression according to RECIST 1.1 criteria in participants receiving BT8009 as a monotherapy or in combination with pembrolizumab.

The time from start of study drug administration (Day 1) until death due to any cause in participants receiving BT8009 as a monotherapy or in combination with pembrolizumab.

Proportion of participants with confirmed complete response or partial response to BT8009 as a monotherapy according to RECIST 1.1 criteria categorized by Nectin-4 expression status.

Proportion of participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency with confirmed complete response or partial response according to RECIST 1.1 criteria

Duration of objective response (complete or partial response) by RECIST 1.1 in participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency receiving BT8009 as a monotherapy or in combination with pembrolizumab.

Proportion of participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency who have complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks according to the RECIST Version 1.1 criteria.

The time from start of study drug administration until disease progression according to RECIST 1.1 in participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency receiving BT8009 as a monotherapy or in combination with pembrolizumab.

The time from start of study drug administration until death due to any cause in participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency receiving BT8009 as a monotherapy or in combination with pembrolizumab.

Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone and in combination with pembrolizumab.

Plasma concentrations (for impact of renal impairment) of BT8009 and MMAE from Part C participants taking BT8009 as a monotherapy.

Number of participants positive for anti-drug antibodies (ADA) from all participants receiving BT8009 as a monotherapy or in combination with pembrolizumab

Number of participants with advanced solid tumor malignancies associated with Nectin-4 expression receiving BT8009 with normal renal function or mild renal insufficiency who experience treatment-emergent adverse events using CTCAE v5.0 criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)	NCT06225596	Metastatic Urot...	BT8009 BT8009 BT8009 Pembrolizumab Gemcitabine + c... Avelumab	18 Years -	BicycleTx Limited
Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies	NCT04561362	Advanced Solid ... Urinary Bladder... Triple Negative... Carcinoma, Non-... Ovarian Neoplas...	BT8009 Pembrolizumab	18 Years -	BicycleTx Limited
Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies	NCT04561362	Advanced Solid ... Urinary Bladder... Triple Negative... Carcinoma, Non-... Ovarian Neoplas...	BT8009 Pembrolizumab	18 Years -	BicycleTx Limited

Spots Global Cancer Trial Database for bt8009

Every month we try and update this database with for bt8009 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bt8009

Every month we try and update this database with for bt8009 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bt8009 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.