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

NCT07227168
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
200
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Lead sponsor
Sutro Biopharma, Inc.
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Start date
2025-11-07
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Number of sites
9
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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.
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Short title
A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-04-01
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First posted
2025-11-12
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Registry last updated
2026-08-27
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Primary completion date
2027-12-01
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Start date
2025-11-07
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Participants
200
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Participant count basis
Estimated
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Planned participants
200
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Protocol amendments
0
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Number of sites
9
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sutro Biopharma, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07227168
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ClinicalTrials.gov ID
NCT07227168
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

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Targets (1)