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Monoclonal Antibodies
STRO-002 + Bevacizumab for Ovarian Cancer
Phase 1
Waitlist Available
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
Summary
This trial tests the safety and effectiveness of combining STRO-002 and Bevacizumab in patients with advanced ovarian cancer that hasn't responded to standard treatments. STRO-002 targets cancer cells directly, and Bevacizumab stops blood vessel growth to tumors.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 2019 Phase 3 trial • 660 Patients • NCT0162724918%
Vitreous floaters
17%
Vision blurred
13%
Conjunctival haemorrhage
12%
Eye pain
12%
Nasopharyngitis
11%
Hypertension
8%
Visual acuity reduced
7%
Headache
7%
Lacrimation increased
6%
Eye irritation
6%
Vitreous haemorrhage
6%
Dry eye
6%
Cataract
5%
Sinusitis
5%
Eye pruritus
2%
Renal failure chronic
2%
Renal failure
2%
Vomiting
1%
Osteomyelitis
1%
myocardial infarction
1%
coronary artery disease
1%
hypertensive heart disease
1%
Diabetic gastroparesis
1%
Cough
1%
Pneumonia
1%
Cellulitis
1%
Peripheral vascular disorder
1%
Diabetic ketoacidosis
1%
Dyspnoea
1%
Hypoglycaemia
1%
anaemia
1%
Chest pain
1%
Localised infection
1%
Sepsis
1%
Urinary tract infection
1%
Acute respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aflibercept
Bevacizumab
Ranibizumab
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
STRO-002
2019
Completed Phase 1
~140
Bevacizumab
2013
Completed Phase 4
~5540
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
STRO-002 is an antibody-drug conjugate that targets folate receptor alpha, delivering cytotoxic agents directly to ovarian cancer cells, thereby minimizing damage to healthy cells. Bevacizumab, on the other hand, is a monoclonal antibody that inhibits VEGF, preventing the formation of new blood vessels that tumors need for growth and metastasis.
These targeted therapies are significant for ovarian cancer patients as they offer the potential for improved efficacy and reduced side effects compared to traditional chemotherapy.
Find a Location
Who is running the clinical trial?
Sutro Biopharma, Inc.Lead Sponsor
5 Previous Clinical Trials
981 Total Patients Enrolled
2 Trials studying Ovarian Cancer
736 Patients Enrolled for Ovarian Cancer
Arturo Molina, MDStudy ChairSutro Biopharma
2 Previous Clinical Trials
206 Total Patients Enrolled
1 Trials studying Ovarian Cancer
136 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.
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