Primary Outcomes:

Primary Outcome 1 - Measure: Cohorts A-1, A-2 and C: Number of participants with treatment emergent adverse events receiving BT8009 alone and in combination with nivolumab to assess safety and tolerability

Primary Outcome 1 - Time Frame: From cycle 1 day 1 until 30 days after the end of treatment (each cycle is 28 days)

Primary Outcome 2 - Measure: Cohort A-1 and A-2 (escalations): Number of participants with dose limiting toxicities on BT8009 alone and in combination with nivolumab

Primary Outcome 2 - Time Frame: From cycle 1 day 1 to the end of cycle 1 (each cycle is 28 days)

Primary Outcome 3 - Measure: Cohort B-1 and B-2 (expansions): Objective response rate (ORR) to assess the clinical activity of BT8009 as a monotherapy and in combination with nivolumab

Primary Outcome 3 - Time Frame: Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or death or up to three years

Primary Outcome 4 - Measure: Cohort B-1 and B-2 (expansions): Duration of response to assess the clinical activity of BT8009 as a monotherapy and in combination with nivolumab

Primary Outcome 4 - Time Frame: Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or death or up to three years

Primary Outcome 5 - Measure: Cohort B-1 and B-2 (expansions): Clinical benefit rate to assess the clinical activity of BT8009 as a monotherapy and in combination with nivolumab

Primary Outcome 5 - Time Frame: Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or death or up to three years

Primary Outcome 6 - Measure: Cohort B-1 and B-2 (expansions): Time to tumor progression to assess the clinical activity of BT8009 as a monotherapy and in combination

Primary Outcome 6 - Time Frame: Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or death or up to 3 years

Primary Outcome 7 - Measure: Cohort B-1 and B-2 (expansions): Progression free survival time to assess the clinical activity of BT8009 as a monotherapy and in combination with nivolumab

Primary Outcome 7 - Time Frame: Every 8 weeks for the first 12 months then every 12 weeks until disease progression or death for up to three years

Primary Outcome 8 - Measure: Cohort B-1 and B-2 (expansions): Progression free survival rate at 6 months to assess the clinical activity of BT8009 as a monotherapy and in combination with nivolumab using RECIST 1.1

Primary Outcome 8 - Time Frame: Every 8 weeks after cycle 1 day 1 for 6 months (each cycle is 28 days)

Primary Outcome 9 - Measure: Cohort B-1 and B-2 (expansions): Overall survival rate at 12 months to assess the clinical activity of BT8009 as a monotherapy and in combination with nivolumab using RECIST 1.1

Primary Outcome 9 - Time Frame: Every 3 months for up to 1 year

Condition:

• Advanced Solid Tumor
• Urinary Bladder Neoplasm
• Pancreatic Neoplasms
• Triple Negative Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Stomach Neoplasm
• Esophageal Neoplasms
• Ovarian Neoplasm

Eligibility

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No