> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-stro-004-in-adults-with-refractory-recurrent-11d0798d-461a-454c-8afe-5b823257028b > Record changed: 2026-10-13 # A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer NCT07227168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) Participants 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) Lead sponsor Sutro Biopharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) Start date 2025-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) Number of sites 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) ## Title and summary **Summary** This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts: \* Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF). \* Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity. \* Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Short title** A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Official title** A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory/Recurrent Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) ## Dates **Completion date** 2028-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **First posted** 2025-11-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Registry last updated** 2026-08-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Start date** 2025-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) ## Size and sites **Participants** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Planned participants** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Number of sites** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Lead sponsor** Sutro Biopharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) ## Identifiers **Registry ID** NCT07227168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **ClinicalTrials.gov ID** NCT07227168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) ## Outcomes ### Primary outcomes 1. Part 1A: Number of participants with Dose-limiting Toxicities (DLTs) Timeframe: Up to Day 21 2. Part 1A, 1B: Percentage of participants with Treatment-Emergent Adverse Events (TEAEs), with severity determined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grading scale Timeframe: Up to 12 Months 3. Part 1A, 1B, 1C: Percentage of participants with clinical laboratory abnormalities, with severity determined according to the CTCAE v5.0 grading scale Timeframe: Up to 12 months 4. Part 1B: Objective Response Rate (ORR) Timeframe: Up to 12 months Best response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1) 5. Part 1B: Disease control rate (DCR) Timeframe: Up to 12 months The proportion of participants with best response of CR, PR or Stable Disease (SD) per RECIST V1.1 6. Part 1B: Duration of Response (DOR) Timeframe: Up to 12 months Time from first occurrence of objective response to the time of Progressive Disease (PD) according to RECIST v1.1 or death from any cause, whichever comes first 7. Part 1B: Progression-Free Survival (PFS) Timeframe: Up to 12 months Time from first dose to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first 8. Part 1B: 12-month survival rate Timeframe: 12 months Percentage of participants alive 12 months after first dose of study treatment 9. Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale Timeframe: Up to 12 months ### Secondary outcomes 1. Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints Timeframe: Up to 12 months 2. Part 1A, 1B, 1C: Immunogenicity Timeframe: Up to 12 months As measured by circulating antidrug antibody (ADA) over time 3. Part 1A: Objective Response Rate (ORR) Timeframe: Best response of CR or PR per RECIST V1.1 Up to 12 months 4. Part 1A, 1C: Disease Control Rate (DCR) Timeframe: Up to 12 months Proportion of participants with best response of CR, PR or SD per RECIST V1.1 5. Part 1A, 1C: Duration of Response (DOR) Timeframe: Up to 12 months Time from first occurrence of objective response to the time of PD according to RECIST v1.1 or death from any cause, whichever comes first 6. Part 1A,1C: Progression-Free Survival (PFS) Timeframe: Up to 12 months Time from first dose to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first 7. Part 1A,1C: 12-month survival rate Timeframe: 12 months Proportion of participants alive 12 months after the date of first dose of study treatment Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) ## Sites - UC San Diego Moores Cancer CenterSan Diego, United StatesRecruiting - SCRI DenverDenver, United StatesRecruiting - Georgetown University Medical CenterWashington D.C., United StatesRecruiting - SCRI FCS SarasotaSarasota, United StatesRecruiting - Mass General Cancer CenterBoston, United StatesRecruiting - Tisch Cancer Institute, Icahn School of Medicine at Mount SinaiNew York, United StatesRecruiting - NEXT AustinAustin, United StatesRecruiting - NEXT San AntonioSan Antonio, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07227168) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Sutro Biopharma, Inc.](https://trialight.com/data/company/sutro-biopharma-inc-72f418c8-f4f7-4a15-b2b5-35a5fedee2de.md) ### Conditions (10) - [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Esophageal cancer](https://trialight.com/data/condition/esophageal-cancer-a3b5271c-e6d4-537b-8dfd-9391c60e2af2.md) - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Neoplasm of esophagus](https://trialight.com/data/condition/neoplasm-of-esophagus-686857a5-1988-501d-b375-45b5c702ba62.md) - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) - [Urothelial neoplasm](https://trialight.com/data/condition/urothelial-neoplasm-00407cf0-9e25-53f7-a483-718f07ae3e8d.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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