MC# 22-34 - Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies

  • Agent(s): BT8009
  • Disease Type(s): Bladder, Ovarian, Lung-NSCLC, Breast- Triple Negative
  • Phase(s): I, II
  • Drug Classification(s): Targeted Therapy, Antibody Drug Conjugate
  • Molecular Target(s): Nectin-4

Mechanism of Action

BT8009 selectively binds to nectin-4. After internalization and proteolytic cleavage by peptidases that are upregulated in the tumor microenvironment (TME), MMAE binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces apoptosis in nectin-4 overexpressing tumor cells.


In this study, the sponsor and investigators want to learn:

  • How much of BT8009 can be given with an acceptable level of side effects alone and in combination with pembrolizumab
  • The effects of BT8009 (good and bad) alone and in combination with pembrolizumab
  • How much of BT8009 is absorbed into the blood and how fast it is removed
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:
    1. 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
    2. 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 solid tumor advanced, recurrent disease confirmed as Nectin-4 positive who must have failed at least one prior line of therapy and radiologically progressed on most recent line of therapy.
  • Part C renal insufficiency cohort: Patients with solid tumor, advanced disease who have renal insufficiency.
Exclusion Criteria
  • 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.

Parts A-2 and B-2 Cohorts Exclusion Criteria

  • Prior organ transplant (including allogeneic)
  • Active systemic infection requiring therapy
  • History of interstitial lung disease


  • Dallas, TX - Mary Crowley Cancer Research - Medical City
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Re: MC# 22-34