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 |
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Recruitment Status :
Recruiting
First Posted : November 20, 2018
Last Update Posted : February 9, 2023
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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 |
This study is a phase 1, open-label, multicenter, dose-escalation study with dose expansion to identify the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D) and to evaluate the safety, tolerability, and preliminary antitumor activity of STRO-002 in adult subjects with advanced epithelial ovarian cancer (EOC), including fallopian or primary peritoneal cancer, and endometrial cancer. Fallopian tube and primary peritoneal cancers are treated in the same manner as epithelial ovarian cancers and are thus included in this phase 1 study. Subjects enrolled in the study will be required to have progressive or recurrent disease after standard approved therapy as defined in the study eligibility criteria. The study has completed dose escalation and is currently in dose expansion, enrolling endometrial and ovarian cancer subjects.
All subjects enrolled on the study are required to have tumor tissue for determining folate receptor alpha (FolRα) expression levels, either from a prior surgery or tumor biopsy or from a biopsy performed during study screening. The testing for FolRα is done via an ICH assay. A minimum level of FolRα expression is required for enrollment for endometrial cancer but not for ovarian cancer.
Study drug, STRO-002, is administered by intravenous (IV) infusion on day 1 of 21-day cycles. Clinical evaluations and/or laboratory tests will be performed at a pre-specified schedule-weekly for cycles 1-4, and at the beginning of every cycle starting with cycle 5 as described in the schedule of assessments. Samples for PK analysis will occur at specific times on days 1, 8, and 15 of cycles 1 and 4, Day 1 of cycles 2, 3, and 5 and at the end of treatment (EOT) visit. The study requires imaging with a CT or MRI scan of the chest abdomen and pelvis at screening, every 6 weeks after enrollment for the first 18 weeks, then every 9 weeks, and at the end of treatment (EOT) visit. Additional X-rays may be required to confirm disease responses and per local institution standard of care.
Additional clinical evaluations and lab testing may occur at the discretion of the investigator.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | N/A |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | The study is a modified 3+3 dose escalation study with a dose expansion. Dose escalation is in advanced ovarian cancer patients with relapsed or refractory disease to standard approved therapy. Dose expansion includes 2 cancer populations, ovarian cancer and endometrial cancer. The ovarian cancer expansion cohorts are Cohort A and Cohort C. Cohort A is a dose ranging design with randomization into 2 dose levels of STRO-002, 4.3 mg/kg and 5.2mg/kg. Cohort C is a single dose cohort design, STRO-002 5.2 mg/kg with prophylactic pegfilgrastim. Dose expansion in endometrial cancer (Cohort B) is a single dose cohort design, STRO-002 5.2 mg/kg. Endometrial subjects with prior pelvic irradiation will start treatment of STRO-002 at 4.3 mg/kg with step up to 5.2 mg/kg. |
| 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 2024 |
| Estimated Study Completion Date : | August 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: STRO-002 treatment
Dose Escalation: STRO-002 at increasing dose levels Dose Expansion: STRO-002 at 4.3 mg/kg and 5.2 mg/kg |
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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:
- Age ≥ 18 years
- Measurable disease per RECIST 1.1
- ECOG performance status (0-1)
- Life expectancy > 3 months
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Pathological confirmation of disease under study (historical information, diagnosis, pathology report, etc)
- Expansion Cohorts A and C: High-grade serous EOC, fallopian tube cancer or primary peritoneal cancer
- Expansion Cohort B: Histologically diagnosed epithelial endometrial cancer (endometrioid and serous adenocarcinomas; undifferentiated carcinoma; mixed epithelial carcinoma; or adenocarcinoma NOS)
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Relapsed and/or progressive disease
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Dose Expansion Cohorts A and C (Ovarian Cancer):
- Platinum resistant and received 1-3 prior regimens or
- Platinum sensitive and either:
- Progressed after 2 prior lines of platinum therapy (regardless of platinum status)and received 2-3 prior regimens or
- Progressed after 1 line of platinum therapy and 1 line of non-platinum therapy and received a total of 2-3 prior regimens if contraindicated to receive second platinum regimen.
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Dose Expansion Cohort B (Endometrial Cancer):
- Relapsed or progression after at least 1 platinum-based chemotherapy regimen or 1 immunotherapy-based regimen but not to exceed more than 3 prior regimens.
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- Fresh or archival tumor tissue samples
Exclusion Criteria:
- Low grade (grade 1) ovarian carcinoma, clear cell, mucinous and sarcomatous ovarian carcinomas (Cohort A).
- Endometrial carcinosarcomas, leiomyosarcoma and stromal sarcomas (Cohort B).
- Prior treatment with a FolRα-targeting ADCs or FolRα-targeting vaccines
- Platinum-refractory during frontline treatment (Cohorts A and C)
- Greater than 3 lines of prior treatment
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
- Preexisting clinically significant ocular disorders, clinically significant pre-exisiting ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
- Metastatic central nervous system or meningeal disease
- 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 | 650-676-4689 | STRO-002ClinDev@sutrobio.com |
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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: | February 9, 2023 |
| Last Verified: | February 2023 |
| 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 |
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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 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 Uterine Neoplasms Uterine Diseases Fallopian Tube Diseases |