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

Phase 1RecruitingNCT07227168

Sutro Biopharma, Inc.200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC Non-Small Cell Lung Cancer NSCLC Esophageal Cancer Gastric Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (6)

SCRI Denver

Denver, Colorado, United States

RECRUITING

SCRI FCS Sarasota

Sarasota, Florida, United States

RECRUITING

Mass General Cancer Center

Boston, Massachusetts, United States

NOT_YET_RECRUITING

NEXT Austin

Austin, Texas, United States

RECRUITING

NEXT San Antonio

San Antonio, Texas, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Up to 12 months

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

Part 1B: Disease control rate (DCR)

The proportion of participants with best response of CR, PR or Stable Disease (SD) per RECIST V1.1

Time frame: Up to 12 months

Part 1B: Duration of Response (DOR)

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

Time frame: Up to 12 months

Part 1B: Progression-Free Survival (PFS)

Time from first dose to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first

Time frame: Up to 12 months

Part 1B: 12-month survival rate

Percentage of participants alive 12 months after first dose of study treatment

Time frame: 12 months

Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale

Time frame: Up to 12 months

Secondary Outcomes

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

Time frame: Up to 12 months

Part 1A, 1B, 1C: Immunogenicity

As measured by circulating antidrug antibody (ADA) over time

Time frame: Up to 12 months

Part 1A: Objective Response Rate (ORR)

Up to 12 months

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

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

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

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

Time frame: Up to 12 months

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

Time from first dose to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first

Time frame: Up to 12 months

Part 1A,1C: 12-month survival rate

Proportion of participants alive 12 months after the date of first dose of study treatment

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts