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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A STRO-004 Monotherapy | Experimental |
| |
| Part 1B STRO-004 Monotherapy | Experimental |
| |
| Part 1C STRO-004 in Combination with Pembrolizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STRO-004 | Drug | IV Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1A: Number of participants with Dose-limiting Toxicities (DLTs) | Up to Day 21 | |
| 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 | Up to 12 Months | |
| Part 1A, 1B, 1C: Percentage of participants with clinical laboratory abnormalities, with severity determined according to the CTCAE v5.0 grading scale | Up to 12 months | |
| Part 1B: Objective Response Rate (ORR) | Best response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1) | Up to 12 months |
| Part 1B: Disease control rate (DCR) | The proportion of participants with best response of CR, PR or Stable Disease (SD) per RECIST V1.1 | Up to 12 months |
| Part 1B: Duration of Response (DOR) | 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 | Up to 12 months |
| Part 1B: Progression-Free Survival (PFS) | Time from first dose to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first | Up to 12 months |
| Part 1B: 12-month survival rate |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints | Up to 12 months | |
| Part 1A, 1B, 1C: Immunogenicity | As measured by circulating antidrug antibody (ADA) over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sutro Clinical Development | Contact | 650-801-6416 | ClinicalTrials@sutrobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCRI Denver | Recruiting | Denver | Colorado | 80218 | United States |
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| Pembrolizumab | Drug | IV Infusion |
|
Percentage of participants alive 12 months after first dose of study treatment |
| 12 months |
| Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale | Up to 12 months |
| Up to 12 months |
| Part 1A: Objective Response Rate (ORR) | Up to 12 months | Best response of CR or PR per RECIST V1.1 |
| Part 1A, 1C: Disease Control Rate (DCR) | Proportion of participants with best response of CR, PR or SD per RECIST V1.1 | Up to 12 months |
| Part 1A, 1C: Duration of Response (DOR) | 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 | Up to 12 months |
| Part 1A,1C: Progression-Free Survival (PFS) | Time from first dose to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first | Up to 12 months |
| Part 1A,1C: 12-month survival rate | Proportion of participants alive 12 months after the date of first dose of study treatment | 12 months |
| SCRI FCS Sarasota | Recruiting | Sarasota | Florida | 34232 | United States |
|
| Mass General Cancer Center | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
|
| NEXT Austin | Recruiting | Austin | Texas | 78758 | United States |
|
| NEXT San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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