> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-1-study-of-stro-006-in-adults-with-refractory-solid-021cd7f6-ef1c-4a3c-91e0-0383e441d117 > Record changed: 2026-11-04 # Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic NCT07807345 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) Participants 285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) Lead sponsor Sutro Biopharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) Start date 2026-10-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) Number of sites 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) ## Title and summary **Summary** This study is a first-in-human (FIH) Phase 1 open-label, multicenter study including three parts: \* Part 1A is a dose escalation of STRO-006 monotherapy in selected tumor types reported to commonly express ITGB6\. Part 1A will determine the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of STRO-006\. \* Part 1B is a dose expansion in one or more indications, as determined by the Sponsor, to further evaluate a STRO-006 monotherapy dose, examine anti-tumor activity, and determine the recommended Phase 2 dose (RP2D) of STRO-006 monotherapy. \* Part 1C is a combination dose escalation to determine safety, tolerability, PK, and preliminary anti-tumor activity of STRO-006 combined with pembrolizumab. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Short title** Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Official title** A Phase 1 Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO 006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) ## Dates **Completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **First posted** 2026-09-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Registry last updated** 2026-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Primary completion date** 2028-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Start date** 2026-10-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) ## Size and sites **Participants** 285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Planned participants** 285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Number of sites** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Lead sponsor** Sutro Biopharma, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) ## Identifiers **Registry ID** NCT07807345 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **ClinicalTrials.gov ID** NCT07807345 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) ## Outcomes ### Primary outcomes 1. Part 1A, 1C: Incidence and severity of Dost-limiting Toxicities (DLTs) Timeframe: 21 days 2. Part 1A, 1C: Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) Timeframe: 21 days 3. Part 1B: Objective Response Rate (ORR) Timeframe: 2.5 years 4. Part 1B: Disease control rate (DCR) Timeframe: 2.5 years 5. Part 1B: Duration of Response (DOR) Timeframe: 2.5 years 6. Part 1B: Progression-Free Survival (PFS) Timeframe: 2.5 years 7. Part 1B: Rate of OS12 Timeframe: 12 months 8. Part 1B: Incidence and severity of treatment emergent adverse events and serious adverse events Timeframe: 21 days ### Secondary outcomes 1. Part 1A, Part 1B, Part 1C: Standard PK parameters for the ADC, total antibody, and exatecan payload following single- and repeat-dose administration. Timeframe: 2.5 years 2. Part 1A, Part 1B, Part 1C: Incidence of circulating ADA over time Timeframe: 2.5 years 3. Part 1A, 1C: Objective Response rate (ORR) Timeframe: 2.5 years 4. Part 1A, Part 1C: Disease control rate (DCR) Timeframe: 2.5 years 5. Part 1A, Part 1C: Duration of Response (DOR) Timeframe: 2.5 years 6. Part 1A, Part 1C: Progression-Free Survival (PFS) Timeframe: 2.5 years 7. Part 1A, Part 1C: Rate of OS12 Timeframe: 1 year Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Histologically or cytologically documented refractory solid tumors that are recurrent or metastatic including: HNSCC (excluding EBV-positive nasopharyngeal carcinoma), NSCLC, esophageal/gastric cancer, colorectal cancer, endometrial carcinoma, urothelial carcinoma, and breast cancer (HR-positive \[HER2-positive or HER2-negative\] and TNBC subtype) - Age ≥ 18 years - Life expectancy of at least 3 months - Willingness and ability to comply with the study protocol and long - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1-term follow-up (LTFU) assessments - Has received standard systemic therapies with known clinical benefit, or is considered inappropriate for such therapies, in the opinion of the investigator. In the dose escalation Phases (Parts 1A and 1C), there is no limit on the number of prior therapies - Expansion Phase (Part 1B) only: Up to two prior therapies are allowed. For participants with AGA-driven adenocarcinoma NSCLC up to four prior therapies are allowed - Measurable disease per RECIST v1.1. - Adequate hematologic and organ function ### Exclusion criteria - Prior anticancer treatment with an ADC with a TOP1 inhibitor payload. (Prior therapy with an ITGB6-targeted ADC is otherwise allowed.) - Prior anticancer therapy (prior to first dose of study treatment): chemotherapy within ≤ 2 weeks, ICI ≤ 3 weeks, ADCs ≤ 3 weeks, palliative radiation therapy ≤ 2 weeks, and major surgery ≤ 4 weeks of C1D1\. If not specified, ≥ 5 half-lives or 2 weeks, whichever is longer, since administration of prior therapy must have elapsed - Residual Common Terminology Criteria for Adverse Events (CTCAE) v5 ≥ Grade 2 toxicity from prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 peripheral neuropathy, which is controlled, and endocrinopathies secondary to prior ICI controlled by hormonal treatment. For Part 1C only: discontinued prior immunotherapy due to treatment-related toxicity - Untreated or active brain metastases and/or leptomeningeal disease - Participants with active ILD or active, non-infectious pneumonitis or a history of active pneumonitis ≤ 6 months from the first dose of study treatment - Significant, concurrent renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease that could impact participation in this clinical trial - Previous solid organ or bone marrow transplantation - Concurrent participation in another therapeutic treatment trial Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) ## Sites - SCRI at Florida Cancer SpecialistsOrlando, United StatesRecruiting - Massachusetts General BrighamBoston, United StatesNot yet recruiting - OU Health Stephenson Cancer CenterOklahoma City, United StatesNot yet recruiting - NEXT Oncology DallasIrving, United StatesRecruiting - Texas Tech University Health Sciences CenterLubbock, United StatesNot yet recruiting - NEXT Oncology VirginiaFairfax, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07807345) ## 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 (14) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.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) - [Endometrium neoplasm](https://trialight.com/data/condition/endometrium-neoplasm-26985bd5-b9dd-55b8-9a46-6068daab5c23.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) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) Primary condition - [Neoplasm of esophagus](https://trialight.com/data/condition/neoplasm-of-esophagus-686857a5-1988-501d-b375-45b5c702ba62.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Transitional cell carcinoma](https://trialight.com/data/condition/transitional-cell-carcinoma-19611feb-3997-59b1-ad3d-49b845cbe40f.md) - [Urothelial carcinoma](https://trialight.com/data/condition/urothelial-carcinoma-b2aa266d-2d5f-5e5d-a0de-62274f2dc094.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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