STRO-002 + Bevacizumab for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Sutro Biopharma, Inc.

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Low grade ovarian carcinoma, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, ongoing immunosuppressive therapy and certain conditions like uncontrolled hypertension or active infections may affect eligibility.

What data supports the effectiveness of the drug Bevacizumab (Avastin) for ovarian cancer?

Bevacizumab, when combined with chemotherapy, has been shown to significantly prolong progression-free survival (the time during which the cancer does not get worse) in women with newly diagnosed advanced ovarian cancer and in those with recurrent disease. It is approved for use in combination with other drugs for these conditions, and studies have confirmed its activity in ovarian cancer treatment. ^{1 2 3 4 5}

Is the combination of STRO-002 and Bevacizumab safe for treating ovarian cancer?

Bevacizumab, also known as Avastin, has been used in treating ovarian cancer and is generally safe, but it can cause side effects like high blood pressure, bleeding, and protein in the urine. Serious but rare side effects include blood clots, wound healing problems, and gastrointestinal issues. These side effects are usually manageable by doctors. ^{1 6 7 8 9}

How is the drug STRO-002 + Bevacizumab unique for treating ovarian cancer?

The combination of STRO-002 and Bevacizumab is unique because it targets the vascular endothelial growth factor (VEGF) to inhibit tumor blood vessel growth, which is a novel approach compared to traditional chemotherapy. Bevacizumab, already used in combination with other drugs for ovarian cancer, is being explored with STRO-002 to potentially enhance its effectiveness and offer a new treatment option. ^{1 2 10 11 12}

Research Team

Arturo Molina, MD

Principal Investigator

Sutro Biopharma

Eligibility Criteria

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.

Inclusion 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.

Exclusion Criteria

Prior treatment with other FolRα targeting agents unless approved by a Sutro medical monitor or designee

Significant concurrent, uncontrolled medical condition

You have a low grade (Grade 1) ovarian cancer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Dose Escalation

STRO-002 is administered at increasing dose levels with bevacizumab to determine the recommended phase 2 dose (RP2D)

Approximately 24 months

Every 3 weeks (in-person)

Dose Expansion

Approximately 40 subjects receive STRO-002 at RP2D with bevacizumab to assess safety and preliminary efficacy

Approximately 24 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• STRO-002 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Experimental :STRO-002 treatment in combination with Bevacizumab Experimental Treatment 2 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

Bevacizumab is already approved in Japan, Canada for the following indications:

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of South Florida, Tampa, FL

Thomas Jefferson University Philadelphia, PA

University of Pennsylvania Philadelphia, PA

Tennessee Oncology Nashville, TN

More Trial Locations

Who Is Running the Clinical Trial?

Sutro Biopharma, Inc.

Lead Sponsor

Trials

7

Recruited

1,100+

Findings from Research

Bevacizumab, an anti-VEGF monoclonal antibody, has been shown to be effective in treating recurrent high-grade serous ovarian cancer, leading to its regulatory approval in many countries, including the US in 2014.

While bevacizumab is widely used and integrated into ovarian cancer treatment guidelines, it does not increase cure rates, highlighting the need for predictive biomarkers to better tailor treatments and weigh the benefits against costs and potential toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-angiogenic agents in ovarian cancer: past, present, and future. Monk, BJ., Minion, LE., Coleman, RL.[2023]

Bevacizumab has been shown to be effective in managing epithelial ovarian cancer, particularly when combined with cytotoxic chemotherapy, as indicated by phase III trial data that demonstrate improved progression-free survival.

There is a compelling argument for using bevacizumab as a single agent in patients with platinum-resistant ovarian cancer, suggesting a more rational and potentially cost-effective approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of bevacizumab in the management of ovarian cancer: an argument for single-agent rather than combination therapy. Markman, M.[2020]

Bevacizumab, an anti-VEGF therapy, has shown efficacy in treating epithelial ovarian cancers, both as a standalone treatment and in combination with other therapies, based on evidence from Phase II trials involving various patient populations.

While most side effects of bevacizumab, such as proteinuria and hypertension, are mild and manageable, there are serious but rare risks like arterial thromboembolism and gastrointestinal perforation, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with bevacizumab in the management of epithelial ovarian cancer. Burger, RA.[2015]

Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor-A, has shown response rates of 16-21% as a single-agent treatment for recurrent ovarian cancer, indicating its efficacy in this context.

In combination with standard chemotherapy for advanced ovarian cancer, bevacizumab significantly improves progression-free survival, although it does not enhance overall survival; the main safety concern is hypertension, with rare but serious risks including gastrointestinal perforation and toxicity to the kidneys and central nervous system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab and ovarian cancer. Garcia, A., Singh, H.[2021]

In a phase II clinical trial involving 62 women with advanced ovarian cancer, the combination of carboplatin, paclitaxel, and bevacizumab showed promising efficacy, with 75% of patients experiencing radiographic responses and a 36-month progression-free survival rate of 58%.

The treatment regimen was generally safe, with mild toxicity reported; however, there were instances of serious side effects, including two pulmonary embolisms and two gastrointestinal perforations, all occurring during the chemotherapy phase, indicating the need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of carboplatin, paclitaxel, and bevacizumab with maintenance bevacizumab as first-line chemotherapy for advanced mullerian tumors. Penson, RT., Dizon, DS., Cannistra, SA., et al.[2022]

Bevacizumab (BV) has been shown to significantly improve progression-free survival in patients with advanced ovarian cancer when combined with standard chemotherapy, although it does not extend overall survival.

While BV is associated with some adverse events like hypertension and bleeding, these can generally be managed effectively, and it also enhances the quality of life for patients with recurrent ovarian cancer, particularly regarding abdominal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab in ovarian cancer: A critical review of phase III studies. Rossi, L., Verrico, M., Zaccarelli, E., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Bevacizumab combination therapy: a review of its use in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Bevacizumab and its use in epithelial ovarian cancer. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Anti-angiogenic agents in ovarian cancer: past, present, and future. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Integrating bevacizumab into the management of epithelial ovarian cancer: the controversy of front-line versus recurrent disease. [2020]

5. England pubmed.ncbi.nlm.nih.gov

The use of bevacizumab in the management of ovarian cancer: an argument for single-agent rather than combination therapy. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Experience with bevacizumab in the management of epithelial ovarian cancer. [2015]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Critical appraisal of bevacizumab in the treatment of ovarian cancer. [2018]

8. Greece pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With Long-term Treatment of Epithelial Ovarian Cancer With Bevacizumab and Chemotherapy. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Bevacizumab and ovarian cancer. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Phase II study of carboplatin, paclitaxel, and bevacizumab with maintenance bevacizumab as first-line chemotherapy for advanced mullerian tumors. [2022]

11. India pubmed.ncbi.nlm.nih.gov

Low-dose (7.5 mg/kg) bevacizumab may be a viable option in recurrent ovarian cancer: A retrospective study. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Bevacizumab in ovarian cancer: A critical review of phase III studies. [2022]