A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer

NCT05200364 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: STRO-002-GM2
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 6

Brief Summary

Phase 1 trial to study the safety, pharmacokinetic and Preliminary Efficacy of STRO-002 in combination with Bevacizumab.

Conditions

Ovarian Cancer; Ovarian Carcinoma; Ovary Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (2)

• Part 1 - Safety and tolerability of STRO-002/bevacizumab as a combination therapy

  Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities observed across STRO-002/bevacizumab dose levels. Incidence of dose-limiting toxicities (DLTs) through Day 1-21 following administration of each initial STRO-002/bevacizumab dose.

  From baseline through end of study (approximately 24 months)

• Part 1 - Determine the recommended phase 2 dose (RP2D) of STRO-002/bevacizumab

  Frequency of DLTs across STRO-002 dose levels

  From baseline through end of study (approximately 24 months)

Secondary Outcomes (3)

• Part 1 - Characterize the pharmacokinetics (PK) of STRO-002 by measuring the maximum plasma concentration (Cmax).

  From baseline through end of study (approximately 24 months)

• Part 1 - Characterize the PK of STRO-002 by measuring the area under the plasma concentration versus time curve (AUC)

  From baseline through end of study (approximately 24 months)

• Part 1 - Assess the formation of anti-drug antibodies (ADAs) to STRO-002 when administered with bevacizumab.

  From baseline through end of study (approximately 24 months)

Study Arms (1)

Experimental :STRO-002 treatment in combination with Bevacizumab

EXPERIMENTAL

Dose Escalation: STRO-002 at increasing dose levels plus bevacizumab at 15 mg/kg Dose Expansion: STRO-002 at RP2D plus bevacizumab at 15 mg/kg

Drug: STRO-002; Drug: Bevacizumab

Interventions

STRO-002 DRUG

intravenous antibody drug conjugate

Experimental :STRO-002 treatment in combination with Bevacizumab

Bevacizumab DRUG

anti-VEGF agent

Also known as: Avastin

Experimental :STRO-002 treatment in combination with Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients are required to have ovarian, fallopian, or primary peritoneal cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• ECOG 0-1
• Life expectancy \> 3 months
• High Grade serous epithelial ovarian cancer (EOC), fallopian tube or primary peritoneal cancer with pathology report documentation of tumor type.
• At least one measurable target lesion per RECIST v1.1.
• Tumor tissue for FolRα expression testing prior to enrollment.
• For dose escalation: tissue may be from either archival tumor tissue or from a biopsy performed during screening.
• For dose expansion part of the study, tissue from both archival tumor tissue and a biopsy performed during screening is required.
• Adequate bone marrow function defined as:
• Absolute neutrophil count (ANC) ≥1500/μL
• Hemoglobin ≥ 9g/dL
• Platelet count ≥ 100 x 10\^3/μL
• Adequate liver function defined as:
• ALT and AST \< 2.5 x ULN
• ALP \< 2.5 x ULN

You may not qualify if:

• Low grade ovarian carcinoma (Grade 1).
• Clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas, endometrial leiomyosarcoma, and endometrial stromal sarcomas.
• Prior treatment with an ADC with a tubulin inhibitor warhead.
• Prior treatment with other FolRα targeting agents unless approved by a Sutro medical monitor or designee.
• Subjects who are primary platinum-refractory during frontline treatment are excluded from the Expansion Cohort (Allowed in Dose Escalation if no more than 1 prior regimen).
• Greater than 4 prior lines of treatment (\> 1 prior if primary platinum refractory).
• Any prior toxicity that required permanent discontinuation of bevacizumab or other contraindication to receive bevacizumab per institutional guidelines.
• Previous solid organ transplantation.
• Current signs/symptoms of bowel obstruction and/or signs/symptoms of or bowel obstruction within 3 months of initiation of study treatment.
• Grade ≥2 toxicity from prior anticancer therapy with the exception of Grade 2 alopecia or Grade 2 neuropathy.
• Uncontrolled hypertension
• Sensory or motor neuropathy Grade \> 1 at screening prior to initiation of study treatment.
• Potentially fatal concurrent or recent malignancy. Subjects with past or current malignancy need to be discussed with the sponsor to determine eligibility.
• Chronic or ongoing active infection requiring systemic treatment.
• Ongoing immunosuppressive therapy, including systemic corticosteroids. Note: Physiologic replacement and use of topical or inhaled corticosteroids are allowed. Dexamethasone may be used to treat chemotherapy induced nausea per institutional guidelines.

Sponsors & Collaborators

• Sutro Biopharma, Inc.: lead

Study Sites (6)

University of South Florida,

Tampa, Florida, 33612, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19017, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Li X, Zhou S, Abrahams CL, Krimm S, Smith J, Bajjuri K, Stephenson HT, Henningsen R, Hanson J, Heibeck TH, Calarese D, Tran C, Yin G, Stafford RL, Yam AY, Kline T, De Almeida VI, Sato AK, Lupher M, Bedard K, Hallam TJ. Discovery of STRO-002, a Novel Homogeneous ADC Targeting Folate Receptor Alpha, for the Treatment of Ovarian and Endometrial Cancers. Mol Cancer Ther. 2023 Feb 1;22(2):155-167. doi: 10.1158/1535-7163.MCT-22-0322.

  PMID: 36459691 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Arturo Molina, MD

  Sutro Biopharma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is designed as a 3+3 dose escalation/de-escalation of STRO-002 given in combination with the labeled dose of bevacizumab. The patient population is relapsed ovarian cancer and the study treatment is the combination of STRO-002 plus bevacizumab. This study will be conducted in 2 parts, dose escalation and dose expansion.

Study Record Dates

• First Submitted: December 19, 2021
• First Posted: January 20, 2022
• Study Start: March 22, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2024-11

Locations

US (6)