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Monoclonal Antibodies

STRO-002 for Ovarian & Endometrial Cancers

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

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

ECOG performance status (0-1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is to study if a new medication is safe and effective when given intravenously every 3 weeks.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sutro Biopharma, Inc.Lead Sponsor

4 Previous Clinical Trials

860 Total Patients Enrolled

2 Trials studying Ovarian Cancer

658 Patients Enrolled for Ovarian Cancer

Arturo Molina, MDStudy ChairSutro Biopharma

2 Previous Clinical Trials

128 Total Patients Enrolled

1 Trials studying Ovarian Cancer

58 Patients Enrolled for Ovarian Cancer

Media Library

STRO-002 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03748186 — Phase 1

Ovarian Cancer Research Study Groups: STRO-002 treatment

Ovarian Cancer Clinical Trial 2023: STRO-002 Highlights & Side Effects. Trial Name: NCT03748186 — Phase 1

STRO-002 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03748186 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this experiment?

"Sutro Biopharma, Inc. is overseeing this trial and requires 160 qualifying individuals to participate in order for it to be completed successfully. The research will take place at Sarah Cannon Research Institute in Nashville, Tennessee and University of South Florida in Tampa, Florida among other sites."

Answered by AI

What are the key goals of this scientific investigation?

"According to the study sponsor, Sutro Biopharma Inc., this clinical trial will span a period of 18 months and its primary objective is to establish the maximum tolerated dose (MTD) of STRO-002. Additionally, it seeks to assess secondary outcomes such as characterizing the pharmacokinetic profile by measuring Cmax after drug administration, determining any anti-drug antibodies formed towards STRO-002, and monitoring treatment-emergent adverse events related to STRO-002 usage."

Answered by AI

Is the use of STRO-002 associated with any health risks?

"The safety of STRO-002 has been given a score of 1 due to its status as a Phase I trial, indicating limited evidence for both its efficacy and security."

Answered by AI

Are there any available slots in this medical research endeavor?

"As per the information on clinicaltrials.gov, this investigation is actively seeking test subjects. The trial was initially advertised in February 2019 and its criteria were last modified in December 2021."

Answered by AI

How many settings are hosting this experiment?

"Currently, 22 medical centres are actively running this trial. Prospective participants should select the closest location among Nashville, Tampa and Spokane as well as other 19 locations to minimise travel expenses."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody Drug Conjugate in Ovarian & Endometrial Cancers

2019. "Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody Drug Conjugate in Ovarian & Endometrial Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03748186.

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