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

- Part A cohorts: patients with advanced, histologically confirmed malignant solid
tumors as follows:

1. urothelial (transitional cell) carcinoma naïve to Nectin-4 directed therapies; or

2. having tumor tissue testing positive for Nectin-4 expression; or

3. solid tumors known to be historically associated with Nectin-4 as follows:
pancreatic, triple negative breast cancer, non-small cell lung cancer, gastric,
esophageal or ovarian cancers.

- Part B-1 and B-2 Nectin-4 basket monotherapy and combination cohorts: patients with
solid tumor advanced, recurrent disease confirmed to express Nectin-4 who are naïve to
Nectin-4 directed therapy, and have exhausted all standard treatment options and had
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
exhausted all appropriate standards of care options and also 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

- Patients 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