Overview

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

Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bicycle Tx Limited
Treatments:
Nivolumab
Criteria
Key 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.

- Part A cohorts: patients with advanced, histologically confirmed malignant solid
tumors that recurred after or have been refractory to previous therapy:

1. urothelial (transitional cell) carcinoma (fresh biopsy or an archived sample must
be submitted); or

2. having pancreatic, breast, non-small-cell lung cancer (NSCLC), gastric,
esophageal, head and neck, or ovarian tumor tissue 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.

Key Exclusion Criteria (all patients)

- Prior treatment with Nectin-4 targeted 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.

Parts A-2 and B-2 Nivolumab Combination Cohorts 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