A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
← catalyst calendarNCT07227168 · readout ≤ 499 d
Sponsored by Sutro Biopharma, Inc. (industry) · STRO — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
200estimated
Sites
9
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-11-07 | actual | When the study began enrolling |
| Primary completion | Dec 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-11-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Head and Neck Squamous Cell Carcinoma HNSCC
- Non-Small Cell Lung Cancer NSCLC
- Esophageal Cancer
- Gastric Cancer
- Colorectal Cancer
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Cervical Cancer
- Endometrial Cancer
- Urothelial Cancer
Interventions
- Drug: STRO-004
- Drug: Pembrolizumab
Primary outcomes
what the primary-completion date above is the date OFPart 1A: Number of participants with Dose-limiting Toxicities (DLTs)
measured 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
measured 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
measured Up to 12 months
Part 1B: Objective Response Rate (ORR)
measured Up to 12 months
Part 1B: Disease control rate (DCR)
measured Up to 12 months
Part 1B: Duration of Response (DOR)
measured Up to 12 months
Part 1B: Progression-Free Survival (PFS)
measured Up to 12 months
Part 1B: 12-month survival rate
measured 12 months
Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale
measured Up to 12 months
Permalink · STRO's whole pipeline · Catalyst calendar · Every registered study · What changed