What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as Bevacizumab combined with chemotherapy agents like carboplatin and paclitaxel, have known side effects. Bevacizumab can cause hypertension, proteinuria, gastrointestinal perforations, and thromboembolic events. Chemotherapy agents often lead to myelosuppression, neuropathy, alopecia, and gastrointestinal symptoms. The combination with novel agents like STRO-002 may introduce additional side effects, but specific data on STRO-002 is not detailed.

What prior FDA approvals exist?

Bevacizumab, a VEGF inhibitor, has received FDA approval for use in combination with chemotherapy for the treatment of ovarian cancer, demonstrating significant improvements in progression-free survival (PFS) and overall survival (OS). Other approved treatments for ovarian cancer include angiogenesis inhibitors and PARP inhibitors, which are used as maintenance therapy in platinum-sensitive recurrent cases. These therapies aim to inhibit tumor growth and extend patient survival.

What other types of research exist?

Promising alternatives to STRO-002 in combination with Bevacizumab for ovarian cancer patients include: 1) Pembrolizumab and Lenvatinib, which have shown improvements in progression-free survival and overall survival in endometrial cancer and may be applicable to ovarian cancer. 2) Carboplatin and Paclitaxel with Bevacizumab, which has demonstrated improved progression-free survival in advanced epithelial ovarian cancer. These alternatives offer different mechanisms of action and have shown efficacy in clinical trials.

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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

No Placebo-Only Group

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through end of study (approximately 24 months) for reporting.

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 • NCT01627249

18%

Vitreous floaters

17%

Vision blurred

13%

Conjunctival haemorrhage

12%

Eye pain

12%

Nasopharyngitis

11%

Hypertension

Visual acuity reduced

Headache

Lacrimation increased

Eye irritation

Vitreous haemorrhage

Dry eye

Cataract

Sinusitis

Eye pruritus

Renal failure chronic

Renal failure

Vomiting

Osteomyelitis

myocardial infarction

coronary artery disease

hypertensive heart disease

Diabetic gastroparesis

Cough

Pneumonia

Cellulitis

Peripheral vascular disorder

Diabetic ketoacidosis

Dyspnoea

Hypoglycaemia

anaemia

Chest pain

Localised infection

Sepsis

Urinary tract infection

Acute respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Aflibercept

Bevacizumab

Ranibizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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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.