Primary Outcomes:

Primary Outcome 1 - Measure: The proportion of subjects experiencing dose limiting toxicities

Primary Outcome 1 - Time Frame: 28 days

Primary Outcome 2 - Measure: The incidence and severity of adverse events (AEs) and serious adverse events

Primary Outcome 2 - Time Frame: 2 years

Primary Outcome 3 - Measure: Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)

Primary Outcome 3 - Time Frame: 2 years

Primary Outcome 4 - Measure: Duration of response, defined as the time from date of first response (CR or PR)

Primary Outcome 4 - Time Frame: 2 years

Condition:

• HER2 Positive Solid Tumors

Eligibility

Criteria:
Inclusion Criteria:

- Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) or amplified solid tumor

- Subjects must have received prior therapies known to confer clinical benefit (unless
ineligible or refused to receive)<br/>
- Measurable disease per RECIST 1.1

- Tumor lesion amenable for biopsy or able to provide tissue from biopsy within last 6
months

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Adequate hematologic, hepatic, and cardiac function

Exclusion Criteria:

- History of allergic reactions to certain components of SBT6050 or similar drugs

- Untreated brain metastases

- Active autoimmune disease or a documented history of autoimmune disease or syndrome

- Human immunodeficiency virus infection, active hepatitis B infection or hepatitis C
infection

- Additional protocol defined inclusion/exclusion criteria may apply.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No