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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

PHASE2PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

High grade serous epithelial ovarian cancer, fallopian tube or primary peritoneal cancer

Age ≥ 18 years

ECOG performance status 0 to 1

Positive FOLR1 expression per central laboratory testing

Relapsed platinum-resistant epithelial ovarian cancer and received a total of 1 to 3 prior regimens

Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless subject has documented contraindication

At least 1 measurable target lesion per RECIST v1.1

Adequate organ function

Exclusion criteria

Low grade (Grade 1) ovarian carcinoma, clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas

Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor

Primary platinum-refractory disease

History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment

Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition

Previous solid organ transplantation

History or clinical signs of meningeal or active central nervous system involvement

Concurrent participation in another therapeutic treatment trial

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: Female

Things to know

Study dates

Study start: 2023-07-12

Primary completion: 2027-08-01

Study completion finish: 2028-02-01

Study type

TREATMENT

Phase

PHASE2

PHASE3

Trial ID

NCT05870748

Intervention or treatment

DRUG: Luveltamab tazevibulin

DRUG: Pegfilgrastim

DRUG: Gemcitabine

DRUG: Paclitaxel

DRUG: Pegylated liposomal doxorubicin

DRUG: Topotecan

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer
• Epithelial Ovarian Cancer
• Platinum-resistant Ovarian Cancer

Condition: Ovarian Cancer, Fallopian Tube Cancer and more
DRUG: Luveltamab tazevibulin and other drugs
Camperdown, New South Wales, Australia and more
Sponsor: Sutro Biopharma, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Chris O'Brien Lifehouse

Research sites nearby

Select from list below to view details:

Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Luveltamab tazevibulin dose Cohort A 5.2 mg/kg q3w with prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg q3w for Cycle 3 onwards	DRUG: Luveltamab tazevibulin 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.
EXPERIMENTAL: Luveltamab tazevibulin dose Cohort B 4.3 mg/kg q3w	DRUG: Luveltamab tazevibulin 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.
ACTIVE_COMPARATOR: Part 2: IC Chemotherapy * 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	DRUG: Gemcitabine 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Progression Free Survival (PFS)	time between the date of first dose and the first date of documented progression or death	up to 24 months
Objective Response Rate (ORR)	Best response of complete response (CR) or partial response (PR) per RECIST 1.1.	up to 24 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Overall Survival (OS)	Time between date of first dose and date of death due to an cause or end of study.	up to 24 months
Duration of Response (DOR)	Confirmed CR or PR from the first documented response to the date of documented disease progression or death.	up to 24 months
Incidence and severity of adverse events [Safety and tolerability]	Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities.	up to 24 months
Quality of life (QLQ-OV28)	Quality of Life Questionnaire Ovarian Cancer 28 is a 28-item ovarian cancer supplemental module that evaluates the quality of life of ovarian cancer patients. It assesses abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal/menopausal symptoms, body image, attitude to disease/treatment and sexual functioning.	up to 24 months

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: 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