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