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

  • End date
    Jun 15, 2023
  • participants needed
  • sponsor
    BicycleTx Limited
Updated on 15 September 2022
breast cancer
lung cancer
brain metastases
triple negative breast cancer
targeted therapy
line of therapy
cancer of the ovary
lung carcinoma


This clinical trial is evaluating a drug called BT8009 alone and in combination with nivolumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency.

The main goals of this study are to:

  • Find the recommended dose of BT8009 that can be given safely to participants alone and in combination with nivolumab
  • Learn more about the side effects and effectiveness of BT8009 alone and in combination with nivolumab
  • Learn more about BT8009 alone and in combination with nivolumab
  • Learn more about BT8009 alone in patients with kidney disease


BT8009 consists of a Bicycle peptide (Bicycle®) which binds selectively to Nectin-4, and is covalently attached to a spacer and a cleavable linker attached to a cytotoxin (MMAE).

This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent given once weekly and in combination with nivolumab. 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 nivolumab and to determine a recommended Phase II dose (RP2D). Following a selection of a recommended Phase II dose (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 nivolumab in patients with select advanced solid tumors. Part C will evaluate safety and tolerability of chosen RP2D of BT8009 in patients with renal insufficiency.

Condition Advanced Solid Tumor, Urinary Bladder Neoplasm, Pancreatic Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasm, Esophageal Neoplasms, Ovarian Neoplasm
Treatment Nivolumab, BT8009
Clinical Study IdentifierNCT04561362
SponsorBicycleTx Limited
Last Modified on15 September 2022


Yes No Not Sure

Inclusion Criteria

Life expectancy ≥12 weeks
Must have exhausted all standard treatment options, including appropriate targeted therapies, for example, EGFR or ALK therapies for relevant oncogene driver NSCLC patients; or available MMAE-containing ADC treatment in urothelial carcinoma; or patients for which no standard therapy is considered appropriate or to provide clinical benefit, as assessed by the Investigator
Part A cohorts: Patients with the following tumor histology
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 tumor that recurred after or has been refractory to prior therapy (fresh tumor biopsy or an archived sample testing positive for Nectin-4 expression)
Part B-1 and B-2 Nectin-4 basket monotherapy and combination cohorts: patients with
Part C renal insufficiency cohort: Patients with solid tumor, advanced disease who have renal insufficiency
solid tumor advanced, recurrent disease confirmed as Nectin-4 positive who
must have failed at least one prior line of therapy and radiologically
Key Exclusion Criteria (all patients)
progressed on most recent line of therapy
Clinically relevant troponin elevation
Uncontrolled diabetes
Uncontrolled, symptomatic brain metastases
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)
Systemic IV anti-infective treatment, or fever within the last 14 days prior to first dose of BT8009

Exclusion Criteria

Prior organ transplant (including allogeneic)
Active systemic infection requiring therapy
History of interstitial lung disease
Other protocol-defined Inclusion/Exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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