Cervical Cancer, Colorectal Cancer, Endometrial Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Squamous Cell Carcinoma HNSCC, Non-Small Cell Lung Cancer NSCLC, Pancreatic Ductal Adenocarcinoma (PDAC), Urothelial Cancer
Conditions
Keywords
Tissue Factor (TF), STRO-004, Antibody Drug Conjugate, ADC
Brief 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.
Interventions
DRUGSTRO-004
IV Infusion
DRUGPembrolizumab
IV Infusion
Sponsors
Sutro Biopharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) |
| Part 1B: Disease control rate (DCR) | Up to 12 months | The proportion of participants with best response of CR, PR or Stable Disease (SD) per RECIST V1.1 |
| Part 1B: Duration of Response (DOR) | 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 |
| Part 1B: Progression-Free Survival (PFS) | 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 |
| Part 1B: 12-month survival rate | 12 months | Percentage of participants alive 12 months after first dose of study treatment |
| Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale | Up to 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints | Up to 12 months | — |
| Part 1A, 1B, 1C: Immunogenicity | Up to 12 months | As measured by circulating antidrug antibody (ADA) over time |
| Part 1A: Objective Response Rate (ORR) | Best response of CR or PR per RECIST V1.1 | Up to 12 months |
| Part 1A, 1C: Disease Control Rate (DCR) | Up to 12 months | Proportion of participants with best response of CR, PR or SD per RECIST V1.1 |
| Part 1A, 1C: Duration of Response (DOR) | 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 |
| Part 1A,1C: Progression-Free Survival (PFS) | 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 |
| Part 1A,1C: 12-month survival rate | 12 months | Proportion of participants alive 12 months after the date of first dose of study treatment |
Countries
United States
Contacts
CONTACTSutro Clinical Development
Outcome results
None listed