Luveltamab Tazevibulin for Lung Cancer

No longer recruiting at 10 trial locations

Overseen By Jennifer Oliver, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sutro Biopharma, Inc.

Must not be taking: Immunosuppressants, Monoclonal antibodies

Disqualifiers: CNS metastases, COPD, Cardiac disease, 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: 3

Duration: up to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Luveltamab Tazevibulin for individuals with advanced or metastatic non-small cell lung cancer that expresses a specific protein, FOLR1. The goal is to determine the treatment's effectiveness in slowing or stopping cancer growth. Participants receive the treatment every three weeks, with a possible dose increase if deemed safe. Suitable candidates have previously tried several treatments for this type of lung cancer and experienced disease progression. Participants must have undergone at least two prior treatments and have this specific type of lung cancer with the FOLR1 protein. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Luveltamab Tazevibulin is likely to be safe for humans?

Research has shown that luveltamab tazevibulin has been tested for safety in people with advanced cancers. In a previous study, no new safety issues emerged, and the results aligned with earlier safety data. Common side effects resembled those of other treatments, such as tiredness and nausea.

The current trial is in Phase 2, indicating that the treatment has undergone earlier trials and proved safe enough for further study. However, while these results are encouraging, more information is needed to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Luveltamab tazevibulin is unique because it targets lung cancer in a novel way by combining an antibody with a microtubule inhibitor. Most current treatments for lung cancer, like chemotherapy and immunotherapy, work by broadly attacking cancer cells or boosting the immune system to fight them. However, Luveltamab tazevibulin specifically binds to cancer cells with its antibody component and then uses its microtubule inhibitor to disrupt cell division, which may result in more precise targeting of cancer cells and potentially fewer side effects. Researchers are excited about its potential to improve treatment outcomes and provide a more targeted approach compared to standard chemotherapy regimens.

What evidence suggests that Luveltamab Tazevibulin might be an effective treatment for lung cancer?

Studies have shown that Luveltamab Tazevibulin, the treatment tested in this trial, shows promise for treating non-small cell lung cancer (NSCLC), particularly when cancer cells contain the protein FOLR1. Research indicates that this treatment has produced positive results in lab tests, demonstrating effectiveness in controlled settings before human trials. It targets specific cancer cells, potentially slowing tumor growth. Early results in other similar cancers have also been positive, suggesting it could be effective for this type of lung cancer as well. While more information is needed, these findings offer hope for its effectiveness in treating advanced NSCLC. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults with advanced or metastatic non-small cell lung cancer who've had at least 2 but no more than 4 prior treatments can join. They must have a certain type of tumor marker (FOLR1), measurable disease, good performance status, and organ function. Excluded are those with previous transplants, other ongoing trials, specific past treatments for FOLR1, untreated brain metastases, severe allergies to monoclonal antibodies or immunosuppressive therapy.

Inclusion Criteria

At least 1 measurable target lesion per RECIST 1.1

I am fully active or can carry out light work.

My organs are working well.

Exclusion Criteria

Concurrent participation in another therapeutic treatment trial

I have had a solid organ transplant.

I have been treated with a specific type of cancer drug targeting FOLR1 or drugs that contain a substance to stop cancer cells from growing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive luveltamab tazevibulin intravenously every 3 weeks until disease progression, intolerable toxicity, elective withdrawal, or study termination

up to 24 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Luveltamab Tazevibulin

Trial Overview The trial is testing Luveltamab tazevibulin in patients who have previously treated non-small cell lung cancer expressing FOLR1. It's a Phase 2 study which means they're looking at how effective this treatment is and gathering more information on its safety.

How Is the Trial Designed?

Group I: Luveltamab tazevibulin Experimental Treatment 1 Intervention

4.3 mg/kg q3w Eligible subjects with stable disease (SD) may escalate to 5.2 mg/kg q3w after Cycle 4, with Sponsor approval.

Who Is Running the Clinical Trial?

Sutro Biopharma, Inc.

Lead Sponsor

Trials

7

Recruited

1,100+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40293943/

The Anti-FRα Antibody-Drug Conjugate Luveltamab ... The Anti-FRα Antibody-Drug Conjugate Luveltamab Tazevibulin Demonstrates Efficacy in Non-Small Cell Lung Cancer Preclinical Models and Induces ...

2. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/3299/761081/Abstract-3299-Anti-FR-antibody-drug-conjugate

Abstract 3299: Anti-FRα antibody-drug conjugate luveltamab ... Here, we report preclinical data to support therapeutic targeting of advanced non-small cell lung cancer (NSCLC), for which there remains an ...

3. sutrobio.com sutrobio.com/sutro-biopharma-announces-initiation-of-refr%CE%B1me-l1-phase-2-trial-with-luvelta-for-patients-with-non-small-cell-lung-cancer/

Sutro Biopharma Announces Initiation of REFRαME-L1 ... REFRαME-L1 is a Phase 2 trial evaluating the safety and efficacy of luvelta in adult patients with previously treated advanced or metastatic NSCLC with FRα ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS5637

The REFRaME-01 (GOG-3086, ENGOT-79ov, and APGOT ... Luvelta was designed to treat multiple cancers with a broad range of FRα expression. Luvelta demonstrated preliminary antitumor activity in ...

5. sutrobio.com sutrobio.com/sutro-biopharma-announces-updated-data-from-phase-1b-study-of-luvelta-in-combination-with-bevacizumab-at-esmo-2024/

Sutro Biopharma Announces Updated Data from Phase 1b ... In this study, luvelta plus bevacizumab has demonstrated encouraging antitumor activity in patients with late-stage ovarian cancer irrespective of Folate ...

6. 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%.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12402782/

The Anti-FRα Antibody–Drug Conjugate Luveltamab ... Aggregating the data from the lung cancer microarrays, we observed a prevalence of 48% and 16% FRα-expressing tumors (TPS ≥1%) in non-squamous and squamous ...