Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic

Part of paid clinical trials in La Jolla, California.

Sponsor
Sutro Biopharma, Inc.
Study ID
NCT07807345
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STRO-006 — DRUG
    IV infusion
  • Pembrolizumab — DRUG
    IV infusion

Study Details

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.

Key Dates

First listed
Sep 8, 2026
Start date
Sep 14, 2026
Status verified
Aug 2026
Primary completion
Feb 29, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
285 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A STRO-006 monotherapy
  • Experimental: Part 1B STRO-006 monotherapy
  • Experimental: Part 1C STRO-006 in combination with pembrolizumab

Primary Outcome Measure

Part 1A, 1C: Incidence and severity of Dost-limiting Toxicities (DLTs) [ Time Frame: 21 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
UCSD Moores Cancer CenterLa JollaCalifornia92093
Clinical Trials Office
[email protected]
650-801-6416
Lyudmila Bazhenova, MD (PRINCIPAL_INVESTIGATOR)
SCRI at Florida Cancer SpecialistsOrlandoFlorida32829
Elizabeth Gilmore Griffith
[email protected]
904-380-2433
Cesar Perez, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General BrighamBostonMassachusetts22031
Clinical Trials Office
[email protected]
650-801-6416
Thomas Roberts, MD (PRINCIPAL_INVESTIGATOR)
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104
Clinical Trials Office
[email protected]
650-801-6416
Susanna Ulahannan, MD (PRINCIPAL_INVESTIGATOR)
NEXT Oncology DallasIrvingTexas75039
Aislyn Morales
[email protected]
(972) 893-8800
Shiraj Sen, MD (PRINCIPAL_INVESTIGATOR)
Texas Tech University Health Sciences CenterLubbockTexas79415
Clinical Trials Office
[email protected]
650-801-6416
Alexander Philipovskiy, MD (PRINCIPAL_INVESTIGATOR)
NEXT Oncology VirginiaFairfaxVirginia22031
Maybelle De La Rosa
[email protected]
(703) 783-4518
Alex Spira, MD (PRINCIPAL_INVESTIGATOR)

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