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

ConditionsHead and Neck Squamous Cell Carcinoma HNSCCNon-Small Cell Lung Cancer NSCLCEsophageal CancerGastric CancerColorectal CancerPancreatic Ductal Adenocarcinoma (PDAC)Cervical CancerEndometrial CancerUrothelial Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSutro Biopharma, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • STRO-004

    Drug

    IV Infusion

  • Pembrolizumab

    Drug

    IV Infusion

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Part 1A STRO-004 MonotherapyExperimental treatment 1 intervention
Group B: Part 1B STRO-004 MonotherapyExperimental treatment 1 intervention
Group C: Part 1C STRO-004 in Combination with PembrolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1A: Number of participants with Dose-limiting Toxicities (DLTs)

Time frame
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

Time frame
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

Time frame
Up to 12 months
4

Part 1B: Objective Response Rate (ORR)

Best response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)

Time frame
Up to 12 months

Secondary outcomes

1

Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints

Time frame
Up to 12 months
2

Part 1A, 1B, 1C: Immunogenicity

As measured by circulating antidrug antibody (ADA) over time

Time frame
Up to 12 months
3

Part 1A: Objective Response Rate (ORR)

Up to 12 months

Time frame
Best response of CR or PR per RECIST V1.1
4

Part 1A, 1C: Disease Control Rate (DCR)

Proportion of participants with best response of CR, PR or SD per RECIST V1.1

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sutro Biopharma, Inc.

Lead sponsor

Source ClinicalTrials.gov
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