What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, particularly monoclonal antibodies and targeted therapies, often have side effects such as nausea, fatigue, anemia, and gastrointestinal issues. For example, olaparib, a PARP inhibitor, is associated with nausea, fatigue, vomiting, and anemia. Bevacizumab, another targeted therapy, can cause hypertension, proteinuria, and increased risk of bleeding. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

FDA-approved treatments for ovarian cancer that are similar to the monoclonal antibody STRO-002 include bevacizumab, a monoclonal antibody targeting VEGF, and PARP inhibitors like olaparib, niraparib, and rucaparib. Bevacizumab is used in combination with chemotherapy for both platinum-sensitive and platinum-resistant ovarian cancer. PARP inhibitors are used as maintenance therapy in patients with BRCA mutations or those with platinum-sensitive relapsed disease.

What other types of research exist?

Promising novel alternatives to STRO-002 for ovarian cancer patients include: 1) Olaparib, a PARP inhibitor, which has shown efficacy as maintenance therapy in platinum-sensitive relapsed ovarian cancer, particularly in patients with BRCA mutations. 2) Rucaparib, another PARP inhibitor, effective as both maintenance therapy and monotherapy for recurrent, platinum-sensitive ovarian cancer. 3) Niraparib, a PARP inhibitor, which has demonstrated benefits in progression-free survival for patients with platinum-sensitive ovarian cancer. These therapies have been supported by clinical trials and offer targeted treatment options for ovarian cancer patients.

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Monoclonal Antibodies

STRO-002 for Ovarian & Endometrial Cancers

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

Pathological confirmation of disease under study (historical information, diagnosis, pathology report, etc)

ECOG performance status (0-1)

Must not have

Metastatic central nervous system or meningeal disease

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of STRO-002, a new IV drug, in adults with advanced ovarian and related cancers that have not responded to other treatments. The drug targets a specific protein on cancer cells to help stop their growth.

Who is the study for?

This trial is for adults with certain types of ovarian and endometrial cancers who have relapsed or progressed after treatment. They should be in good physical condition, have a life expectancy over 3 months, and not exceed three prior cancer treatments. Those with severe chronic diseases, more than three lines of previous treatments, or specific cancer subtypes are excluded.

What is being tested?

The study tests STRO-002, an experimental drug targeting FolRα given every 3 weeks intravenously. It's a Phase 1 trial focusing on the safety profile, how the body processes the drug (pharmacokinetics), and its preliminary effectiveness against ovarian and endometrial cancers.

What are the potential side effects?

While specific side effects for STRO-002 aren't listed here, common ones for similar drugs include allergic reactions to infusion, fatigue, nausea or vomiting. Since it targets cancer cells using antibodies linked to chemotherapy drugs (ADCs), there may also be typical chemo-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis is confirmed by a pathology report.

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My cancer has returned or gotten worse.

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I have been diagnosed with a specific type of endometrial cancer.

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My endometrial cancer returned after 1-3 treatments including platinum or immunotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or its coverings.

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I do not have severe eye, lung, heart, brain disorders, or other serious health issues.

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My cancer did not respond to initial platinum-based chemotherapy.

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I have had more than 3 different treatments for my condition.

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I have previously been treated with FolRα-targeting drugs.

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My cancer is a type of uterine sarcoma.

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My ovarian cancer is low grade or is a specific type like clear cell.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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: Define the maximum tolerated dose (MTD) of STRO-002

Part 1: Define the recommended phase 2 dose (RP2D) of STRO-002

Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-002)

+2 more

Secondary study objectives

Part 1: Assess the formulation of anti-drug antibodies to STRO-002

Part 1: Characterize the PK of STRO-002 by measuring the clearance (CL)

Part 1: Characterize the PK of STRO-002 by measuring the half-life (t1/2) of STRO-002

+10 more

Other study objectives

Part 1: Preliminary assessment of the anti-tumor activity of STRO-002

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: STRO-002 treatmentExperimental Treatment1 Intervention

Dose Escalation: STRO-002 at increasing dose levels Dose Expansion: STRO-002 at 4.3 mg/kg and 5.2 mg/kg

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

STRO-002

2019

Completed Phase 1

~140

0 / 13Eligibility criteria met

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

Targeted therapies and monoclonal antibodies, such as those being studied in the trial STRO-002, work by specifically targeting cancer cells while sparing normal cells. These treatments often focus on specific proteins or pathways that are overexpressed or mutated in cancer cells. For example, bevacizumab is an angiogenesis inhibitor that targets the vascular endothelial growth factor (VEGF) to prevent tumor blood vessel formation, while PARP inhibitors like olaparib target DNA repair mechanisms in cancer cells with BRCA mutations. These targeted approaches are crucial for ovarian cancer patients as they can potentially reduce side effects and improve treatment efficacy by directly attacking cancer cells and minimizing damage to healthy tissues.