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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
Sponsor:
Information provided by (Responsible Party):
Sutro Biopharma, Inc.

Brief Summary:
Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-002 given intravenously every 3 weeks.

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

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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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Part 2: Evaluate preliminary anti-tumor activity (endometrial cancer patients) [ Time Frame: 24 months ]
    Objective response rate per RECIST 1.1


Secondary Outcome Measures :
  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

  2. 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

  3. 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)

  4. Part 1: Characterize the PK of STRO-002 by measuring the clearance (CL) [ Time Frame: 18 months ]
    Measurement of total body clearance

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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)

  13. Part 2: Characterize the PK of STRO-002 by measuring the clearance (CL) [ Time Frame: 24 months ]
    Measurement of total body clearance


Other Outcome Measures:
  1. Part 1: Preliminary assessment of the anti-tumor activity of STRO-002 [ Time Frame: 18 months ]
    Objective response rate per RECIST 1.1



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Confirmation of diagnosis
  2. Evidence of measureable disease as defined by RECIST 1.1
  3. Age ≥ 18 years
  4. ECOG performance status (0-1)
  5. Life expectancy > 3 months
  6. 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
  7. Adequate bone marrow, liver and renal functions
  8. QTcF <500 msec
  9. Ability to comply with treatment, PK and test schedules
  10. Negative pregnancy test within 7 days and use a method of birth control
  11. 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
  12. 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

  13. 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
  14. 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

    1. FFPE blocks (preferably) or 10 unstained slides from the same block are required for study entry
    2. Cohort A (EOC): FolRα expression is not required for eligibility and will be assessed retrospectively post enrollment

Exclusion Criteria:

  1. Low grade ovarian carcinoma (Grade 1).
  2. Clear cell, mucinous and sarcomatous ovarian carcinomas.
  3. Prior treatment with a FolRα-targeting ADCs or FolRα-targeting vaccines
  4. 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
  5. Greater than 3 lines of prior treatment (Expansion Cohort A [ovarian cancer] only)
  6. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
  7. 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
  8. 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
  9. Previous solid organ transplantation
  10. Sensory or motor neuropathy ≥ grade 2
  11. 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
  12. 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
  13. Ongoing immunosuppressive therapy, including systemic corticosteroids. Note:

    Physiologic replacement and use of topical or inhaled corticosteroids are allowed.

  14. Clinically significant cardiac disease
  15. Clinically significant pre-exisiting ocular disorders
  16. Significant concurrent, uncontrolled medical condition
  17. History or clinical signs of meningeal or active CNS involvement
  18. Known severe chronic obstructive pulmonary disease or asthma
  19. History of significant cerebrovascular disease
  20. Known Human Immunodeficiency Virus seropositivity
  21. 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
  22. Positive serology for hepatitis B defined by a positive test for HBsAg
  23. Concurrent participation in another therapeutic treatment trial

Information from the National Library of Medicine

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


Contacts
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Contact: Craig Berman, MD 650-801-6417 STRO-002ClinDev@sutrobio.com
Contact: Michael Palumbo 6506764689 STRO-002ClinDev@sutrobio.com

Locations
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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         
Sponsors and Collaborators
Sutro Biopharma, Inc.
Investigators
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Study Chair: Arturo Molina, MD Sutro Biopharma
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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