Luveltamab Tazevibulin for Ovarian Cancer
Recruiting at 39 trial locations
CB
JB
Overseen ByJoseph Buscema, MD
Age: 18+
Sex: Female
Trial Phase: Phase 2 & 3
Sponsor: Sutro Biopharma, Inc.
Must be taking: Bevacizumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that prior bevacizumab treatment is required unless there's a contraindication, which suggests some medications might be necessary.
What makes the drug Luveltamab Tazevibulin unique for treating ovarian cancer?
Eligibility Criteria
This trial is for women aged 18+ with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. Participants must have FOLR1-positive tumors, be somewhat active (ECOG 0-1), and have had 1-3 prior treatments including bevacizumab unless contraindicated. They can't join if they've had severe allergies to monoclonal antibodies, certain serious health conditions, previous organ transplants, CNS involvement, are in another treatment trial or have specific types of ovarian carcinoma.Inclusion Criteria
My organs are working well.
I can carry out all my usual activities without help.
I have high grade serous cancer in my ovary, fallopian tube, or peritoneum.
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Exclusion Criteria
Concurrent participation in another therapeutic treatment trial
You have had a solid organ transplant in the past.
I have been treated with specific targeted therapy for cancer.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Part 1
Participants receive luveltamab tazevibulin in two dosing cohorts to select the optimized dosing regimen
6-9 weeks
Every 3 weeks
Treatment Part 2
Evaluation of the selected dosing regimen versus Investigator's Choice chemotherapy
up to 24 months
Every 3-4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
up to 24 months
Treatment Details
Interventions
- Luveltamab Tazevibulin
Trial OverviewThe study tests Luveltamab tazevibulin's effectiveness and safety on women with certain types of ovarian cancer expressing FOLR1. It's a Phase 2 trial where participants also receive Pegfilgrastim to help reduce infection risk from low white blood cell counts.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Luveltamab tazevibulin dose Cohort BExperimental Treatment1 Intervention
4.3 mg/kg q3w
Group II: Luveltamab tazevibulin dose Cohort AExperimental Treatment2 Interventions
5.2 mg/kg q3w with prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg q3w for Cycle 3 onwards
Group III: Part 2: IC ChemotherapyActive Control4 Interventions
* 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sutro Biopharma, Inc.
Lead Sponsor
Trials
7
Recruited
1,100+
GOG Foundation
Collaborator
Trials
48
Recruited
18,500+
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
Trials
41
Recruited
19,200+
Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
Collaborator
Trials
3
Recruited
1,200+
Gynecologic Oncology Group
Collaborator
Trials
251
Recruited
65,400+
Findings from Research
Oregovomab, a monoclonal antibody targeting the CA125 antigen, has shown significant improvements in progression-free and overall survival for patients with advanced ovarian cancer when used alongside first-line chemotherapy, as indicated by preclinical and clinical data.
The ongoing phase III trial is exploring the effectiveness of oregovomab in combination with other treatments, and its manageable toxicity profile suggests it could be a strong candidate for combination therapies in ovarian cancer management.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Oregovomab: an investigational agent for the treatment of advanced ovarian cancer.Pietragalla, A., Duranti, S., Daniele, G., et al.[2021]
In a phase II study involving 33 women with recurrent estrogen receptor-positive ovarian cancer, letrozole showed a clinical benefit in 26% of patients, with one achieving a partial response and seven having stable disease.
Letrozole was well-tolerated, with no severe toxicities reported, and the most common side effects were mild, such as fatigue and sweating, indicating a favorable safety profile for this treatment in a challenging patient population.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy of letrozole in the treatment of recurrent platinum- and taxane-resistant high-grade cancer of the ovary or peritoneum.Ramirez, PT., Schmeler, KM., Milam, MR., et al.[2018]
The combination of mirvetuximab soravtansine and bevacizumab shows promising efficacy in treating women with recurrent ovarian cancer that has high folate receptor alpha (FRα) expression, achieving a 64% objective response rate.
Patients treated with this combination therapy experienced a median progression-free survival of 10.6 months, indicating a significant benefit regardless of their platinum sensitivity status.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
"Significant Activity" for ADC in Ovarian Cancer.[2022]
References
Oregovomab: an investigational agent for the treatment of advanced ovarian cancer. [2021]
Efficacy of letrozole in the treatment of recurrent platinum- and taxane-resistant high-grade cancer of the ovary or peritoneum. [2018]
"Significant Activity" for ADC in Ovarian Cancer. [2022]
Dramatic response to single-agent atezolizumab in a patient with MSI-H serous ovarian cancer. [2022]
Safety and Clinical Activity of Atezolizumab Plus Bevacizumab in Patients with Ovarian Cancer: A Phase Ib Study. [2021]
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