Luveltamab Tazevibulin for Ovarian Cancer

Recruiting at 70 trial locations

Overseen By Joseph Buscema, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Sutro Biopharma, Inc.

Must be taking: Bevacizumab

Must not be taking: FOLR1 ADCs, Tubulin ADCs

Disqualifiers: Low grade carcinoma, Ocular disorders, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called luveltamab tazevibulin (also known as Luvelta or STRO-002) for women with certain types of ovarian cancer. Researchers aim to determine if this treatment is more effective and safer than standard chemotherapy options. Participants will receive either one of two doses of the new treatment or standard chemotherapy for comparison. Women with relapsed ovarian cancer that no longer responds to platinum-based treatments and who have a specific protein (FOLR1) on their cancer cells might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from an innovative therapy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that luveltamab tazevibulin is generally safe for patients with ovarian cancer. At doses between 4.3 to 5.2 mg/kg, patients tolerated the treatment well. Most side effects were mild or manageable. Luveltamab tazevibulin targets specific cancer cells, limiting its impact on healthy cells. Although still under study, the safety data so far appears promising for those considering joining the clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ovarian cancer, which often include chemotherapy drugs like gemcitabine, paclitaxel, and doxorubicin, Luveltamab Tazevibulin offers a fresh approach by focusing on a unique mechanism of action. This investigational drug is designed to target and disrupt specific cancer cell processes, potentially leading to more effective tumor control with fewer side effects. Researchers are particularly excited about Luveltamab Tazevibulin because it’s administered in a way that could enhance patient outcomes by reducing the need for more aggressive chemotherapy regimens, thus potentially improving the quality of life for those affected by ovarian cancer.

What evidence suggests that luveltamab tazevibulin might be an effective treatment for ovarian cancer?

Research shows that luveltamab tazevibulin, which participants in this trial may receive, may effectively treat ovarian cancer, especially in patients whose cancer has a protein called folate receptor alpha (FRα). In earlier studies, this treatment helped shrink tumors in 32% of patients and controlled the disease in 96% of patients with platinum-resistant ovarian cancer and FRα levels above 25%. This means the treatment can reduce tumor size and slow the disease in many patients. Luveltamab tazevibulin works by attaching to the folate receptor, often found on ovarian cancer cells. This targeted approach is why it is expected to be effective for this type of cancer. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Luveltamab Tazevibulin

Trial Overview The 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.

How Is the Trial Designed?

Group I: Luveltamab tazevibulin dose Cohort B Experimental Treatment 1 Intervention

4.3 mg/kg q3w

Group II: Luveltamab tazevibulin dose Cohort A Experimental Treatment 2 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 Chemotherapy Active Control 4 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

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+

Published Research Related to This Trial

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]

A 64-year-old woman with recurrent ovarian cancer, previously unresponsive to standard therapies, showed a near-complete response to the immunotherapy atezolizumab after three cycles, indicating potential efficacy in this patient population.

The patient's tumor exhibited loss of MLH1 and PMS2 proteins, suggesting that identifying specific biomarkers may be crucial for selecting effective treatments for ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dramatic response to single-agent atezolizumab in a patient with MSI-H serous ovarian cancer. Ak, N., Vatansever, S.[2022]

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]

In a phase Ib study involving 20 patients with platinum-resistant ovarian cancer, the combination of atezolizumab and bevacizumab demonstrated a safety profile consistent with the individual drugs, with 95% experiencing treatment-related adverse events, but no grade 5 events reported.

The treatment resulted in a 15% overall response rate, with some patients achieving durable responses lasting up to 18.9 months, and a disease control rate of 55%, indicating potential efficacy in managing this challenging cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Clinical Activity of Atezolizumab Plus Bevacizumab in Patients with Ovarian Cancer: A Phase Ib Study. Moroney, JW., Powderly, J., Lieu, CH., et al.[2021]

Citations

1. sutrobio.com sutrobio.com/wp-content/uploads/2025/03/SGO2025_REFRaME-O1-Oral-Presentation-FINAL.pdf

Efficacy and safety of luveltamab tazevibulin in This presentation describes the outcomes from Phase 2 (dose optimization) of a phase 2/3 study of luveltamab tazevibulin currently under investigation for use ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.5508

Luveltamab tazevibulin (STRO-002), an anti-folate receptor ... These dose expansion data confirm activity of luvelta at starting doses ranging from 4.3-5.2 mg/kg in recurrent OC with FolRα expression as low as TPS>25%.

3. onclive.com onclive.com/view/luveltamab-tazevibulin-produces-responses-in-platinum-resistant-ovarian-cancer-with-low-medium-fr-expression

Luveltamab Tazevibulin Produces Responses in Platinum ... Luveltamab tazevibulin showed a 32% ORR and 96% DCR in platinum-resistant ovarian cancer with FRα expression over 25%. · Patients with low-to- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05870748

NCT05870748 | REFRaME-O1: A Study to Investigate the ... 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 ...

5. sutrobio.com sutrobio.com/wp-content/uploads/2023/01/Sutro-STRO-002-Luvelta-update-Jan-9-2023-FINAL.pdf

Luveltamab Tazevibulin (Luvelta, STRO-002) Phase 1 ... Cohort C data are as of December 8, 2022. Potential to treat ~80% of patients with platinum- resistant ovarian cancer. Efficacy demonstrated by ...

6. sutrobio.com sutrobio.com/sutro-biopharma-presents-data-from-dose-optimization-portion-of-refr%CE%B1me-o1-trial-in-patients-with-platinum-resistant-ovarian-cancer-at-sgo-2025/

Mar 15, 2025 At the selected optimized dose (5.2 mg/kg), luvelta achieved an ORR of 32%1 and a disease control rate (DCR) of 96% compared to an ORR of 13.8% ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24163608

TP010/#1537 Efficacy and safety of luveltamab tazevibulin ... Luveltamab tazevibulin (luvelta) is a FRα-targeting antibody-drug conjugate designed to treat cancers with a broad range of FRα expression.