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

NCT07807345
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
285
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Lead sponsor
Sutro Biopharma, Inc.
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Start date
2026-10-19
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Number of sites
6
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Summary
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.
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Short title
Phase 1 Study of STRO-006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic
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Official title
A Phase 1 Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO 006 in Adults With Refractory Solid Tumors That Are Recurrent or Metastatic
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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
2028-12-01
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First posted
2026-09-08
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Registry last updated
2026-10-23
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Primary completion date
2028-02-01
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Start date
2026-10-19
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Participants
285
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Participant count basis
Estimated
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Planned participants
285
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Protocol amendments
0
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Number of sites
6
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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
NCT07807345
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ClinicalTrials.gov ID
NCT07807345
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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, 1C: Incidence and severity of Dost-limiting Toxicities (DLTs)

    Timeframe: 21 days

  2. Part 1A, 1C: Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: 21 days

  3. Part 1B: Objective Response Rate (ORR)

    Timeframe: 2.5 years

  4. Part 1B: Disease control rate (DCR)

    Timeframe: 2.5 years

  5. Part 1B: Duration of Response (DOR)

    Timeframe: 2.5 years

  6. Part 1B: Progression-Free Survival (PFS)

    Timeframe: 2.5 years

  7. Part 1B: Rate of OS12

    Timeframe: 12 months

  8. Part 1B: Incidence and severity of treatment emergent adverse events and serious adverse events

    Timeframe: 21 days

  1. Part 1A, Part 1B, Part 1C: Standard PK parameters for the ADC, total antibody, and exatecan payload following single- and repeat-dose administration.

    Timeframe: 2.5 years

  2. Part 1A, Part 1B, Part 1C: Incidence of circulating ADA over time

    Timeframe: 2.5 years

  3. Part 1A, 1C: Objective Response rate (ORR)

    Timeframe: 2.5 years

  4. Part 1A, Part 1C: Disease control rate (DCR)

    Timeframe: 2.5 years

  5. Part 1A, Part 1C: Duration of Response (DOR)

    Timeframe: 2.5 years

  6. Part 1A, Part 1C: Progression-Free Survival (PFS)

    Timeframe: 2.5 years

  7. Part 1A, Part 1C: Rate of OS12

    Timeframe: 1 year

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

  • Histologically or cytologically documented refractory solid tumors that are recurrent or metastatic including: HNSCC (excluding EBV-positive nasopharyngeal carcinoma), NSCLC, esophageal/gastric cancer, colorectal cancer, endometrial carcinoma, urothelial carcinoma, and breast cancer (HR-positive [HER2-positive or HER2-negative] and TNBC subtype)
  • Age ≥ 18 years
  • Life expectancy of at least 3 months
  • Willingness and ability to comply with the study protocol and long
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1-term follow-up (LTFU) assessments
  • Has received standard systemic therapies with known clinical benefit, or is considered inappropriate for such therapies, in the opinion of the investigator. In the dose escalation Phases (Parts 1A and 1C), there is no limit on the number of prior therapies
  • Expansion Phase (Part 1B) only: Up to two prior therapies are allowed. For participants with AGA-driven adenocarcinoma NSCLC up to four prior therapies are allowed
  • Measurable disease per RECIST v1.1.
  • Adequate hematologic and organ function

  • Prior anticancer treatment with an ADC with a TOP1 inhibitor payload. (Prior therapy with an ITGB6-targeted ADC is otherwise allowed.)
  • Prior anticancer therapy (prior to first dose of study treatment): chemotherapy within ≤ 2 weeks, ICI ≤ 3 weeks, ADCs ≤ 3 weeks, palliative radiation therapy ≤ 2 weeks, and major surgery ≤ 4 weeks of C1D1. If not specified, ≥ 5 half-lives or 2 weeks, whichever is longer, since administration of prior therapy must have elapsed
  • Residual Common Terminology Criteria for Adverse Events (CTCAE) v5 ≥ Grade 2 toxicity from prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 peripheral neuropathy, which is controlled, and endocrinopathies secondary to prior ICI controlled by hormonal treatment. For Part 1C only: discontinued prior immunotherapy due to treatment-related toxicity
  • Untreated or active brain metastases and/or leptomeningeal disease
  • Participants with active ILD or active, non-infectious pneumonitis or a history of active pneumonitis ≤ 6 months from the first dose of study treatment
  • Significant, concurrent renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease that could impact participation in this clinical trial
  • Previous solid organ or bone marrow transplantation
  • Concurrent participation in another therapeutic treatment trial
Sources for eligibility
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  • SCRI at Florida Cancer SpecialistsOrlando, United StatesRecruiting
  • Massachusetts General BrighamBoston, United StatesNot yet recruiting
  • OU Health Stephenson Cancer CenterOklahoma City, United StatesNot yet recruiting
  • NEXT Oncology DallasIrving, United StatesRecruiting
  • Texas Tech University Health Sciences CenterLubbock, United StatesNot yet recruiting
  • NEXT Oncology VirginiaFairfax, United StatesRecruiting
Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (14)

Targets (1)