Brief Title: A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Part 1A: Number of participants with Dose-limiting Toxicities (DLTs)

Primary Outcome 1 - Timeframe: Up to Day 21

Primary Outcome 2 - Measure: Part 1A

Primary Outcome 2 - Timeframe: Up to 12 Months

Primary Outcome 3 - Measure: 1B: Percentage of participants with Treatment-Emergent Adverse Events (TEAEs)

Primary Outcome 3 - Timeframe: Up to 12 months

Primary Outcome 4 - Measure: with severity determined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grading scale

Primary Outcome 4 - Timeframe: Up to 12 months

Primary Outcome 5 - Measure: Part 1A

Primary Outcome 5 - Timeframe: Up to 12 months

Primary Outcome 6 - Measure: 1B

Primary Outcome 6 - Timeframe: Up to 12 months

Primary Outcome 7 - Measure: 1C: Percentage of participants with clinical laboratory abnormalities

Primary Outcome 7 - Timeframe: Up to 12 months

Primary Outcome 8 - Measure: with severity determined according to the CTCAE v5.0 grading scale

Primary Outcome 8 - Timeframe: 12 months

Primary Outcome 9 - Measure: Part 1B: Objective Response Rate (ORR)

Primary Outcome 9 - Timeframe: Up to 12 months

Primary Outcome 10 - Measure: Part 1B: Disease control rate (DCR)

Primary Outcome 10 - Timeframe: N/A

Primary Outcome 11 - Measure: Part 1B: Duration of Response (DOR)

Primary Outcome 11 - Timeframe: N/A

Primary Outcome 12 - Measure: Part 1B: Progression-Free Survival (PFS)

Primary Outcome 12 - Timeframe: N/A

Primary Outcome 13 - Measure: Part 1B: 12-month survival rate

Primary Outcome 13 - Timeframe: N/A

Primary Outcome 14 - Measure: Part 1C: Percentage of participants with TEAEs

Primary Outcome 14 - Timeframe: N/A

Primary Outcome 15 - Measure: with severity determined according to the CTCAE v5.0 grading scale

Primary Outcome 15 - Timeframe: N/A

CONDITION

• Head and Neck Squamous Cell Carcinoma HNSCC
• Non-Small Cell Lung Cancer NSCLC
• Esophageal Cancer
• Gastric Cancer
• Colorectal Cancer
• Pancreatic Ductal Adenocarcinoma (PDAC)
• Cervical Cancer
• Endometrial Cancer
• Urothelial Cancer

ELIGIBILITY

Inclusion Criteria:
* Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal/Gastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma

- * Age 18 years or older

- * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

- * Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies

- * Availability of tumor tissue

- * Measurable disease per RECIST 1.1

- * Adequate organ function

- * Participants receiving anticoagulants must be on a stable dose
Exclusion Criteria:
* Eye disorders

- * Untreated brain metastases

- * Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition

- * Previous solid organ or bone marrow transplantation

- * Concurrent participation in another therapeutic treatment trial

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Sutro Clinical Development

Phone: 650-801-6416

Email: [email protected]

LOCATION