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Monoclonal Antibodies
STRO-002 + Bevacizumab for Ovarian Cancer
Phase 1
Recruiting
Research Sponsored by Sutro Biopharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through end of study (approximately 24 months)
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective when used with another drug to treat cancer.
Who is the study for?
This trial is for adults over 18 with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. They should have a life expectancy of more than 3 months and at least one measurable lesion. Participants need good kidney, bone marrow, and liver function but can't join if they've had certain treatments like FolRα targeting agents or are pregnant/breastfeeding without using barrier contraception.Check my eligibility
What is being tested?
The study tests STRO-002 combined with Bevacizumab in patients with epithelial ovarian cancer to evaluate safety and early effectiveness. It's a Phase 1 trial where participants' response to the treatment is monitored through various health parameters.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical reactions may include issues related to antibody-drug conjugates such as allergic reactions, lowered blood cell counts leading to increased infection risk or bleeding problems, fatigue, nausea, and potential organ damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline through end of study (approximately 24 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through end of study (approximately 24 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 - Determine the recommended phase 2 dose (RP2D) of STRO-002/bevacizumab
Part 1 - Safety and tolerability of STRO-002/bevacizumab as a combination therapy
Secondary outcome measures
Part 1 - Assess the formation of anti-drug antibodies (ADAs) to STRO-002 when administered with bevacizumab.
Part 1 - Characterize the PK of STRO-002 by measuring the area under the plasma concentration versus time curve (AUC)
Part 1 - Characterize the pharmacokinetics (PK) of STRO-002 by measuring the maximum plasma concentration (Cmax).
Side effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental :STRO-002 treatment in combination with BevacizumabExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
Sutro Biopharma, Inc.Lead Sponsor
4 Previous Clinical Trials
962 Total Patients Enrolled
2 Trials studying Ovarian Cancer
760 Patients Enrolled for Ovarian Cancer
Arturo Molina, MDStudy ChairSutro Biopharma
2 Previous Clinical Trials
230 Total Patients Enrolled
1 Trials studying Ovarian Cancer
160 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- For the part of the study where the dose is increased: specific rules about how your cancer has responded to previous treatments and how it has reacted to platinum-based chemotherapy.You have at least one specific tumor that can be measured according to certain guidelines.Someone who is 18 years or older.You have a low grade (Grade 1) ovarian cancer.You have certain types of ovarian and uterine cancers.You have received a specific type of drug that contains a tubulin inhibitor in the past.To increase the amount of the drug given, the doctors may use a small piece of tissue from a previous tumor or take a new biopsy during the screening process.You need to have a test for FolRα expression in your tumor tissue before joining the study.You have good physical activity and can carry out light activities.Your kidneys work well enough, with a certain level of a substance called creatinine in your blood or a certain amount of creatinine cleared from your body.You have a specific type of ovarian, fallopian tube, or peritoneal cancer confirmed by a pathology report.You are expected to live for more than 3 months.For increasing the dose: specific requirements related to previous treatment not working and sensitivity to platinum-based chemotherapy.There are certain rules about the treatments you have had before, the side effects you experienced, and your medical history.Your bone marrow is working well, with enough white blood cells, red blood cells, and platelets in your blood.Your liver is working well, with certain levels of liver enzymes and bilirubin within normal limits.To be eligible for the dose expansion part of the study, patients must have tumor tissue from both an archival tumor sample and a biopsy done during screening.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental :STRO-002 treatment in combination with Bevacizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are enlisted for this clinical investigation?
"Sutro Biopharma, Inc. is the sponsor of this trial and they must recruit 58 patients that meet its inclusion criteria to carry out the study. The investigation will take place at multiple medical centres including University of South Florida in Tampa, Florida and Medical College of Wisconsin located in Milwaukee, Wisconsin."
Answered by AI
Has the Federal Drug Administration green-lit STRO-002?
"STRO-002's safety has been assessed by our team at Power and given a value of 1 due to its analytical stage. This is a Phase 1 Trial, in which there are limited data supporting efficacy and the drug's security."
Answered by AI
Are there any vacancies open to participants of this research endeavor?
"Affirmative. Documents published on clinicaltrials.gov show that this medical study launched on March 22nd 2022 and is actively recruiting patients. The experiment seeks 58 participants from 6 distinct medical centres."
Answered by AI
How many hospitals are currently participating in this clinical experiment within the state?
"Currently, the study is recruiting from 6 different medical sites. These are located in Tampa, Milwaukee and Nashville plus an additional trio of locations. To reduce time spent travelling to appointments, it may be beneficial to select a centre near you."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Virginia Cancer Specialists
What portion of applicants met pre-screening criteria?
Met criteria
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