Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody Drug Conjugate in Ovarian & Endometrial Cancers
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ClinicalTrials.gov Identifier: NCT03748186 |
Recruitment Status :
Recruiting
First Posted : November 20, 2018
Last Update Posted : January 6, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer Ovarian Carcinoma Ovary Cancer Endometrial Cancer Endometrioid Adenocarcinoma Fallopian Tube Cancer Primary Peritoneal Carcinoma | Drug: STRO-002 | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Part 1 Dose escalation starting at human equivalent dose of 1/6 the highest non-severely toxic dose identified in the glp toxicology study in cynomolgus monkeys.The second dose level increases by 100% of the initial dose, and thereafter by 80%, then 60%, 50%, 40%, 30% and then 20% of the preceding doses. Part 2 Dose Expansion: All subjects to provide tissue samples (tissue blocks, or at minimum 10 slides) for IHC analysis of FolRα expression. Subjects in Expansion Cohort A (ovarian cancer) will be randomized 1:1 and treated with STRO-002 at either 4.3 or 5.2 mg/kg every 3 weeks. Dosing, scoring algorithm and FolRa expression criteria for subjects in Expansion Cohort B (endometrial cancer) has not been determined at the time of this amendment and will be determined and specified with a subsequent protocol amendment prior to enrolling this cohort. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody-Drug Conjugate (ADC), in Patients With Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) and Endometrial Cancers |
Actual Study Start Date : | February 1, 2019 |
Estimated Primary Completion Date : | August 2022 |
Estimated Study Completion Date : | August 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: STRO-002 treatment
STRO-002 at increasing dose levels
|
Drug: STRO-002
intravenous antibody drug conjugate |
- Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-002) [ Time Frame: 18 months ]Incidence of adverse events (AEs) observed across STRO-002 dose levels
- Part 1: Define the recommended phase 2 dose (RP2D) of STRO-002 [ Time Frame: 18 months ]Frequency of dose-limiting toxicity and exposure across STRO-002 dose levels
- Part 1: Define the maximum tolerated dose (MTD) of STRO-002 [ Time Frame: 18 months ]Frequency of dose-limiting toxicity and exposure across STRO-002 dose levels
- Part 2: Evaluate preliminary anti-tumor activity (ovarian, Fallopian and primary peritoneal cancer patients) [ Time Frame: 24 months ]Objective response rate per RECIST 1.1
- Part 2: Evaluate preliminary anti-tumor activity (endometrial cancer patients) [ Time Frame: 24 months ]Objective response rate per RECIST 1.1
- Part 1: Characterize the pharmacokinetics (PK) of STRO-002 by measuring the maximum plasma concentration (Cmax) [ Time Frame: 18 months ]Measurement of maximum plasma concentration after the administration of STRO-002
- Part 1: Characterize the PK of STRO-002 by measuring the half-life (t1/2) of STRO-002 [ Time Frame: 18 months ]Measurement of terminal half-life of STRO-002 after the administration of STRO-002
- Part 1: Characterize the PK of STRO-002 measuring the total area under the concentration versus time curve from zero to infinity (AUCinf) [ Time Frame: 18 months ]Measurement of AUC to infinity (AUCinf)
- Part 1: Characterize the PK of STRO-002 by measuring the clearance (CL) [ Time Frame: 18 months ]Measurement of total body clearance
- Part 1: Characterize the PK of STRO-002 by measuring the the steady state volume of distribution (Vss) [ Time Frame: 18 months ]Measurement of steady state volume of distribution
- Part 1: Assess the formulation of anti-drug antibodies to STRO-002 [ Time Frame: 18 months ]Circulating anti-drug antibodies (ADAs) formed to STRO-002
- Part 2: Further evaluate the incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-002) [ Time Frame: 24 months ]Number of patients with abnormal laboratory values and/or adverse events related to STRO-002 treatment
- Part 2: Evaluate preliminary anti-tumor efficacy with a time-to-event analysis of duration of response (DOR) in patients treated with STRO-002 [ Time Frame: 24 months ]Duration of response per RECIST 1.1
- Part 2: Evaluate preliminary anti-tumor efficacy with a time-to-event analysis of progression-free survival (PFS) in patients treated with STRO-002 [ Time Frame: 24 months ]Progression-free survival per RECIST 1.1
- Part 2: Evaluate preliminary effect of STRO-002 treatment on CA-125 levels [ Time Frame: 24 months ]Response assessment based on the Gynecologic Cancer Intergroup (GCIG) criteria
- Part 2: Characterize the PK of STRO-002 by measuring the maximum plasma concentration (Cmax) [ Time Frame: 24 months ]Measurement of maximum plasma concentration (Cmax) after the administration of STRO-002
- Part 2: Characterize the PK of STRO-002 by measuring the area under the plasma concentration versus time curve (AUC) [ Time Frame: 24 months ]Measurement of AUC to infinity (AUC inf)
- Part 2: Characterize the PK of STRO-002 by measuring the clearance (CL) [ Time Frame: 24 months ]Measurement of total body clearance
- Part 1: Preliminary assessment of the anti-tumor activity of STRO-002 [ Time Frame: 18 months ]Objective response rate per RECIST 1.1

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Patients are required to have ovarian, fallopian, primary peritoneal or endometrial cancer. |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmation of diagnosis
- Evidence of measureable disease as defined by RECIST 1.1
- Age ≥ 18 years
- ECOG performance status (0-1)
- Life expectancy > 3 months
- Toxicities related to prior therapy, such as peripheral neuropathy and arthralgias must return to gr. 1 or less, except for alopecia, which can be gr. 2 or less at time of enrollment
- Adequate bone marrow, liver and renal functions
- QTcF <500 msec
- Ability to comply with treatment, PK and test schedules
- Negative pregnancy test within 7 days and use a method of birth control
- Relapsed and/or progressive disease: progressed after treatment with at least 2 platinum containing regimens or refractory to treatment with platinum containing therapy and with no other approved treatment options
-
Pathological confirmation of disease under study (historical information, diagnosis, pathology report, etc)
a. Cohort A: High-grade serous EOC, fallopian tube cancer or primary peritoneal cancer
-
Relapsed and/or progressive disease
Cohort A (EOC):
- Platinum resistant and received 1-3 prior regimens or
- Progressed after 2 prior lines of platinum therapy (regardless of platinum status) and received 2-3 prior regimens
-
Fresh or archival tumor tissue samples must be provided to Sponsor for FolRα expression analysis as part of eligibility criteria for study entry and prior to study treatment
- FFPE blocks (preferably) or 10 unstained slides from the same block are required for study entry
- Cohort A (EOC): FolRα expression is not required for eligibility and will be assessed retrospectively post enrollment
Exclusion Criteria:
- Low grade ovarian carcinoma (Grade 1).
- Clear cell, mucinous and sarcomatous ovarian carcinomas.
- Prior treatment with a FolRα-targeting ADCs or FolRα-targeting vaccines
- Subjects who are platinum-refractory (no response or disease progression within 3 months of completion of therapy) during frontline treatment are excluded (Expansion Cohort A [ovarian cancer] only) History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
- Greater than 3 lines of prior treatment (Expansion Cohort A [ovarian cancer] only)
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
- Prior anticancer therapy (prior to first dose of study drug): chemotherapy within 3 weeks, PARP inhibitor within 2 weeks, other therapeutic anticancer antibodies within 3 weeks, radio- or toxin-immunoconjugates (eg. ADCs) within 10 weeks, or radiation therapy/ major surgery within 2 weeks
- Preexisting clinically significant ocular disorders including, but not limited to: active or chronic corneal disorders, cataracts (except minor cataracts without significant visual impairment which are allowed),, glaucoma, keratitis, retinopathy, uveitis and Sjogrens syndrome. Myopia, "floaters", watering eyes are not exclusion criteria
- Previous solid organ transplantation
- Sensory or motor neuropathy ≥ grade 2
- Potentially fatal concurrent or recent malignancy. Subjects with past or current malignancy need to be discussed with the sponsor to determine eligibility. Examples of non-exclusionary malignancies include: cervical carcinoma Stage 1B or less; noninvasive basal cell and squamous cell skin carcinoma; localized malignant melanoma with a complete response of a duration of >10 years; low-risk in situ breast cancer treated with curative intent; superficial noninvasive bladder cancer treated with curative intent
- Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
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Ongoing immunosuppressive therapy, including systemic corticosteroids. Note:
Physiologic replacement and use of topical or inhaled corticosteroids are allowed.
- Clinically significant cardiac disease
- Clinically significant pre-exisiting ocular disorders
- Significant concurrent, uncontrolled medical condition
- History or clinical signs of meningeal or active CNS involvement
- Known severe chronic obstructive pulmonary disease or asthma
- History of significant cerebrovascular disease
- Known Human Immunodeficiency Virus seropositivity
- Females who are pregnant or breastfeeding, and all women of child bearing potential unwilling to use adequate barrier contraception while on treatment and for 16 weeks after last dose
- Positive serology for hepatitis B defined by a positive test for HBsAg
- Concurrent participation in another therapeutic treatment trial

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748186
Contact: Craig Berman, MD | 650-801-6417 | STRO-002ClinDev@sutrobio.com | |
Contact: Michael Palumbo | 6506764689 | STRO-002ClinDev@sutrobio.com |
United States, Colorado | |
Rocky Mountain Cancer Center | Recruiting |
Aurora, Colorado, United States, 80012 | |
Contact: Patty Gibson, RN, BSN 303-418-7639 Patricia.Gibson@usoncology.com | |
Principal Investigator: Sami Diab, MD | |
United States, Florida | |
Miami Cancer Institue, Baptist Health South Florida | Recruiting |
Miami, Florida, United States, 33176 | |
Contact: Isabel Moya, BSCR, CCRP 786-527-8861 IsabelMoy@baptisthealth.net | |
Principal Investigator: John Diaz, MD | |
University of South Florida | Recruiting |
Tampa, Florida, United States, 33606 | |
Contact: Matthew Anderson 813-974-1806 mlander5@usf.edu | |
Principal Investigator: Matthew Anderson | |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Hatti Koning 773-834-5722 hkoning@medicine.bsd.uchicago.edu | |
Principal Investigator: John Moroney, MD | |
United States, Nevada | |
Comprehensive Cancer Centers of Nevada | Recruiting |
Las Vegas, Nevada, United States, 89169 | |
Contact: Karyn Mianulli, BSN, RN 702-952-3443 karyn.mianulli@usoncology.com | |
Principal Investigator: Fadi Braiteh, MD | |
United States, North Carolina | |
Levine Cancer Institute | Recruiting |
Charlotte, North Carolina, United States, 28204 | |
Contact: Heather Neagle, RN, BSN 980-442-2303 Heather.Neagle@atriumhealth.org | |
Principal Investigator: R. Wendel Naumann, MD | |
United States, Ohio | |
Ohio State University, James Cancer Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Molly Myers 614-293-3873 Molly.Myers@osumc.edu | |
Principal Investigator: David O'Malley, MD | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Diego Rodgriguez 215-614-0234 diegorod@pennmedicine.upenn.edu | |
Principal Investigator: Lainie Martin, MD | |
Thomas Jefferson University | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Cynthia Perez, BS, CCRP 215-955-6407 cynthia.perez@jefferson.edu | |
Principal Investigator: Russell Schilder, MD | |
United States, Tennessee | |
Sarah Cannon Research Institute | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Sheetal Champaneria 615-329-6875 sheetal.champaneria@sarahcannon.com | |
Principal Investigator: Erika Hamilton, MD | |
United States, Wisconsin | |
Medical College of Wisconsin | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Suki Skandarajah 414-805-5337 sskandarajah@mcw.edu | |
Principal Investigator: Denise Uyar, MD |
Study Chair: | Arturo Molina, MD | Sutro Biopharma |
Responsible Party: | Sutro Biopharma, Inc. |
ClinicalTrials.gov Identifier: | NCT03748186 |
Other Study ID Numbers: |
STRO-002-GM1 |
First Posted: | November 20, 2018 Key Record Dates |
Last Update Posted: | January 6, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endometrial Neoplasms Fallopian Tube Neoplasms Carcinoma, Endometrioid Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Endocrine Gland Neoplasms |
Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Uterine Neoplasms Uterine Diseases Fallopian Tube Diseases |