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5.2 mg/kg q3w with prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg q3w for Cycle 3 onwards

* Gemcitabine 1000 mg/m2 on Days 1, 8, and 15 q4w or 1000mg/m2 on Days 1 and 8 q3w
* Paclitaxel 80 mg/m2 on Days 1, 8, and 15 q4w
* Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 q4w
* Topotecan 4.0 mg/m2on Day 1, 8, and 15 q4w or 1.25 mg/m2 on Days 1 - 5 q3w

Luveltamab tazevibulin is an antibody-drug conjugate targeting FOLR1. It consists of an IgG1 antibody (SP8166) conjugated to cleavable 3-3-aminophenyl hemiasterlin drug-linkers at 4 sites. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death.

Luveltamab tazevibulin

Pegfilgrastim or pegylated G-CSF is approved and used to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs. It increases the proliferation and differentiation of neutrophils.

Pegfilgrastim

Gemcitabine is a chemotherapy regimen used for treating platinum-resistant ovarian cancer. It inhibits ribonucleotide reductase and DNA polymerase, hindering tumor cell growth and promoting cell death.

Paclitaxel is a chemotherapy regimen approved for treatment of previously treated ovarian cancer. It stabilizes microtubules, inhibiting tumor cell replication.

Pegylated liposomal doxorubicin is a chemotherapy regimen approved for treating platinum-resistant ovarian cancer. It inhibits DNA and RNA synthesis by intercalating between base pairs, obstructing tumor cell division.

Pegylated liposomal doxorubicin

Topotecan is a chemotherapy regimen approved for treatment of metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. It binds to topoisomerase I inducing DNA breaks and subsequent tumor cell apoptosis.

Craig Berman, MD

Stacey Kimbell

Joseph Buscema, MD

Julia Rivera Penafiel

John Chan, MD

Hiwot Guebre-Xabiher

Ebony Hoskins, MD

Hany Fleitas

John Diaz, MD

Kathleen Murillo

Matthew Anderson, MD

Melissa Loomis

Pallavi Kumar, MD

Lindsey Allen

Susan Zweizig, MD

Nykole Starks

Lauren Bollinger, MD

Khaliq Nasrati

Brent Tierney, MD

Katy Chalamidas

Karen Finkelstein, MD

Keith Kallas

Bhavana Pothuri, MD

Stephanie Solito

Yi-Chun Lee, MD

Cara King

Amanda Jackson, MD

Jordyn Burks

Floor Backes, MD

Daniel Geyer

Thomas Reid, MD

Daniel Marangoni, PhD

Michael Gold, MD

Tawna Kiely

Charles Anderson, MD

Christopher Darus

Christopher Darus, MD

Krista Budzik

Bethany Bustamante, MD

Ashley Douglas

Russell Schilder, MD

Morgan Heim

Kristi McIntyre, MD

Dominique Marquez

Brandon Sawyer, MD

Alice Bock

Antonio Santillan-Gomez, MD

Melissa Howell

Christine Lee, MD

Kristi Ben-Barka

Chao Yin, MD

Shuo Zhang

Michelle Harrison

Emma Cet

Yeh Chen Lee

Kate Campbell

Bo Gao

Laura Pietrantonio

Lucy Gilbert, MD

Riya Agrawal

Amit Oza, MD

Anna Rapoport

Ronnie Shapira, MD

Seungyeon Kwon

Kidong Kim, MD

MyoungHee Kim

Chi-Heum Cho, MD

Seonhwa Lee

Myong Cheol Lim, MD

So Hee Choi

Young Saing Kim, MD

Saebom Kim

Vera Chia

John Chia, MD

Kathyleen Garcia David

Elaine Lim, MD

A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.

This is a randomized, multicenter, international, open-label, 2-part, Phase 2/3 study designed to assess the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in subjects with relapsed platinum-resistant epithelial ovarian cancer expressing FOLR1.

Part 1 will consist of 2 luveltamab tazevibulin dosing cohorts (Cohort A and Cohort B), with subjects randomized 1:1. Part 1 will be used to select the optimized dosing regimen.

Part 2 will further evaluate the efficacy and safety of the selected dosing regimen versus IC chemotherapy.

Luveltamab tazevibulin will be administered intravenously (IV) over a 1-hour infusion time every 3 weeks.

REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)

time between the date of first dose and the first date of documented progression or death

Best response of complete response (CR) or partial response (PR) per RECIST 1.1.

Time between date of first dose and date of death due to an cause or end of study.

Confirmed CR or PR from the first documented response to the date of documented disease progression or death.

Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities.

GOG Foundation

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Asia-Pacific Gynecologic Oncology Trials Group (APGOT)

Sutro Biopharma, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1	NCT05870748	Ovarian Cancer Epithelial Ovar... Fallopian Tube ... Primary Periton... Platinum-resist...	Luveltamab taze... Pegfilgrastim Gemcitabine Paclitaxel Pegylated lipos... Topotecan	18 Years -	Sutro Biopharma, Inc.
REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1	NCT05870748	Ovarian Cancer Epithelial Ovar... Fallopian Tube ... Primary Periton... Platinum-resist...	Luveltamab taze... Pegfilgrastim Gemcitabine Paclitaxel Pegylated lipos... Topotecan	18 Years -	Sutro Biopharma, Inc.

Spots Global Cancer Trial Database for luveltamab tazevibulin