Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of adverse events as defined as DLTs

Primary Outcome 1 - Time Frame: 28 days

Primary Outcome 2 - Measure: Number of participants with adverse events as a measure of safety and tolerability of NeoTCR-P1 or NeoTCR-P1 in combination with nivolumab

Primary Outcome 2 - Time Frame: 2 years

Primary Outcome 3 - Measure: Maximum Tolerated Dose (MTD) of NeoTCR-P1

Primary Outcome 3 - Time Frame: 2 years

Primary Outcome 4 - Measure: Feasibility of manufacturing NeoTCR-P1

Primary Outcome 4 - Time Frame: 2 years

Condition:

• Solid Tumor

Eligibility

Criteria:
Inclusion Criteria:

- Histologically or cytologically documented incurable or metastatic solid tumors of the
following types: melanoma, UC, ovarian cancer, colorectal cancer, breast cancer (HR+),
or prostate cancer.

- Disease has progressed after at least one available standard therapy or no additional
curative therapies are available.

- Measurable disease per RECIST v1.1

- Eastern cooperative oncology group (ECOG) performance status of 0 or 1

- Adequate hematologic and end organ function determined within 30 days prior to
enrollment.

- Disease-specific criteria related to the specific tumor type are required.

Note: There are additional inclusion criteria. The study center will determine if you meet
all of the criteria.

Exclusion Criteria:

- Known clinically significant liver disease, including active viral, alcoholic, or
other hepatitis, cirrhosis, and/or inherited liver disease

- Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases

- Uncontrolled or symptomatic hypercalcemia

- Pregnancy, lactation, or breastfeeding

- Prior allogeneic stem cell transplant or solid organ transplant

- Prior chimeric antigen receptor therapy or other genetically modified T cell therapy

- Active HIV, Hepatitis B, or Hepatitis C infection

- Active tuberculosis

- Severe infection within 2 weeks prior to enrollment

- Major surgical procedure within 4 weeks prior to enrollment or anticipation of need
for a major surgical procedure during the study.

Note: There are additional exclusion criteria. The study center will determine if you meet
all of the criteria.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No