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

Study summary

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 (Parts B1-B7), Safety and tolerability (Parts B-8, B-9 and C), and characterization of the pharmacokinetics (Part D).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBT8009 and Pembrolizumab

The study team can explain what participation involves.

Who it may be forHER2

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 20, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?24 U.S. locations

Locations may change over time.

Who runs it?BicycleTx Limited

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: BicycleTx Limited
Interventions being studied: Drug: BT8009; Drug: Pembrolizumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers

HER2→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key
Life expectancy ≥12 weeks.
Patients must have measurable disease per RECIST 1.1.
Part A-1 cohorts:
Must have exhausted all standard treatment options, including appropriate targeted therapies; or patients for which no standard therapy is considered appropriate
Patients with advanced, histologically confirmed urothelial (transitional cell) carcinoma that recurred after or has been refractory to prior therapy (fresh tumor biopsy or an archived sample must be submitted); or
Patients with advanced, histologically confirmed pancreatic, breast, non-small-cell lung cancer (NSCLC), gastric, esophageal, head and neck, or ovarian tumors that recurred after or has been refractory to prior therapy (fresh tumor biopsy or an archived sample testing for Nectin-4 expression).
Part A-2:
Must have exhausted all standard treatment options, including appropriate targeted therapies; or patients for which no standard therapy is considered appropriate
Patients with advanced, histologically confirmed urothelial (transitional cell) carcinoma that have progressed following prior therapy
Cohort B-1: Histologically documented urothelial carcinoma, 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.
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.
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-5: Patients with triple-negative breast cancer confirmed negative for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) (i.e., triple-negative) that have progressed following prior therapy.
Cohort B-6: Patients with histologically confirmed non-small cell lung cancer (NSCLC) with no actionable mutations, such as Epidermal Growth Factor Receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion oncogene, or ROS1 that have progressed following prior therapy.
Cohort B-7: Locally advanced or metastatic, histologically confirmed urothelial (transitional cell) carcinoma, ineligible for cisplatin, no prior systemic anticancer treatment for advanced urothelial carcinoma.
Cohort B-8: Locally advanced (unresectable) or metastatic, histologically confirmed breast cancer, either TNBC or hormone receptor (HR) positive and HER-2 negative according to ASCO/CAP guidelines and up to 3 prior lines of therapy for advanced (unresectable) or metastatic disease.
Cohort B-9: Histologically confirmed advanced/metastatic squamous or non-squamous NSCLC, negative for oncogenic driver mutations (EGFR, KRAS, ALK, BRAF, MET, ERRB2).
Cohort C renal insufficiency cohort: Patients with histologically documented urothelial carcinoma, ovarian, triple negative breast, or non-small cell lung cancer that have been previously treated with a locally approved therapy.
Part D supplementary PK: Patients must have histologically confirmed urothelial (transitional cell) carcinoma (patients with squamous differentiation or mixed cell types are eligible); ovarian; triple-negative breast; or non-small cell lung cancer that have been previously treated with a locally approved therapy. Key

Reasons someone may not be able to joinExclusion criteria

(all patients):
Clinically relevant troponin elevation
Uncontrolled diabetes
Known active or untreated CNS and/or carcinomatous meningitis
Grade ≥2 peripheral neuropathy
Active keratitis or corneal ulcerations
Patients with uncontrolled hypertension
History of another malignancy within 3 years before first dose of BT8009 or residual disease from a previously diagnosed malignancy (with some exceptions).
Active systemic infection requiring therapy, or fever within the last 14 days prior to first dose of BT8009.
Prior Stevens-Johnson syndrome/toxic epidermal necrolysis on any MMAE-conjugated drug
Parts A-2 and B-7 Pembrolizumab Combination Cohorts:
Prior organ transplant (including allogeneic)
Diagnosis of clinically relevant immunodeficiency
History of interstitial lung disease
Parts B-2 and B-3: Prior treatment with enfortumab vedotin Other protocol-defined Inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Sarah Cannon Research Institute at HealthONEDenver, Colorado
Ocala Oncology CenterOcala, Florida
Advent HealthOrlando, Florida
Icahn School of Medicine at Mount SinaiNew York, New York
University Hospitals Cleveland Medical CenterCleveland, Ohio
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphia, Pennsylvania
Tennessee Oncology, PLLCNashville, Tennessee
Mary Crowley Cancer Research CenterDallas, Texas
The University of Texas MD Anderson Cancer CenterHouston, Texas
University Health Network, Princess Margaret Cancer CentreToronto, Ontario
Institut BergonieBordeaux
Centre Leon BerardLyon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 20, 2026. Always confirm current availability with the study team.

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