hSTC810 + Paclitaxel for Lung Cancer

No longer recruiting at 13 trial locations

Overseen By Jiwon Hur, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: STCube, Inc.

Must not be taking: Immunotherapy, Chemotherapy, Steroids, others

Disqualifiers: CNS metastases, Autoimmune disease, Hepatitis, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment combining hSTC810 (an experimental treatment) with paclitaxel for individuals with small cell lung cancer (SCLC) that has returned or hasn't responded to initial treatment. The study includes two groups: one receiving a lower dose and the other a higher dose of hSTC810, both combined with paclitaxel. It targets those diagnosed with extensive stage SCLC whose disease has progressed after chemotherapy. Participants must have at least one measurable tumor and should not have conditions like active brain involvement or recent major surgeries. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you have not received immunotherapy, chemotherapy, targeted small molecule therapy, or any other investigational agent within 14 days before starting the study treatment. This means you may need to stop certain medications before joining the trial.

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

Research shows that the treatment hSTC810, when combined with paclitaxel, has promising safety results. In earlier studies, hSTC810, also known as nelmastobart, was generally well-tolerated by patients. Some patients experienced anti-tumor effects, indicating that the treatment works without causing excessive harm.

Paclitaxel has FDA approval for treating other types of cancer, so its safety profile is well-known, though side effects can still occur. Overall, both treatments have been found tolerable, with ongoing research to further confirm the safety of hSTC810. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for lung cancer, like chemotherapy and radiation, work by targeting rapidly growing cancer cells, but they often affect healthy cells too. Researchers are excited about hSTC810 because it offers a potentially more targeted approach. hSTC810 is a novel compound that might work differently by enhancing the effect of Paclitaxel, a well-known chemotherapy drug, without increasing toxicity. The trial explores doses of 400 mg and 800 mg of hSTC810 combined with Paclitaxel, aiming to boost effectiveness while minimizing side effects. This combination could lead to more efficient cancer cell targeting, offering new hope for lung cancer patients.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Studies have shown that paclitaxel is effective for patients with small cell lung cancer, even those who have relapsed. In this trial, participants will receive a combination of hSTC810 and paclitaxel. Research indicates that hSTC810, when combined with paclitaxel, is safe and may show early signs of effectiveness. hSTC810 targets a specific protein, which may help control cancer growth. Although data on hSTC810's effects remain limited, early findings suggest that the combination with paclitaxel looks promising. These results indicate that this treatment approach could benefit lung cancer patients. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with small cell lung cancer that has come back or didn't respond to platinum-based chemo. They should have a life expectancy of at least 3 months, be able to understand the study and agree to use contraception. They must have at least one tumor that can be measured and be in fairly good health (ECOG PS of 0 or 1).

Inclusion Criteria

You are able to comprehend and sign a document detailing the risks associated with participation.

I am fully active or restricted in physically strenuous activity but can do light work.

My small cell lung cancer diagnosis was confirmed through lab tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase Ib Treatment

Evaluation of the safety of hSTC810 with paclitaxel using a 3+3 dose escalation design

21 days

Multiple visits for dose escalation and monitoring

Phase II Treatment

Evaluation of the efficacy of hSTC810 + paclitaxel combination therapy using a Simon 2-stage method

24 weeks

Regular visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• hSTC810
• Paclitaxel

Trial Overview The trial is testing two different doses of hSTC810 combined with Paclitaxel in patients whose extensive stage small cell lung cancer has relapsed or hasn't responded after initial treatment. The goal is to see how safe this combination is and how well it works.

How Is the Trial Designed?

Group I: hSTC810 800 mg + Paclitaxel Experimental Treatment 1 Intervention

hSTC810 800 mg will be administered with a standard dose of paclitaxel

Group II: hSTC810 400 mg + Paclitaxel Experimental Treatment 1 Intervention

hSTC810 400 mg will be administered with a standard dose of paclitaxel

Who Is Running the Clinical Trial?

STCube, Inc.

Lead Sponsor

Trials

3

Recruited

250+

Published Research Related to This Trial

In a phase II trial involving 120 patients with extensive-stage small cell lung cancer, the combination of paclitaxel, carboplatin, and etoposide showed a significantly higher overall response rate of 78% compared to 48% for the paclitaxel and topotecan combination.

The paclitaxel-carboplatin-etoposide regimen also resulted in a longer median time to progression (7.6 months) compared to the paclitaxel-topotecan group (5.5 months), indicating it may be a more effective initial treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel/carboplatin/etoposide versus paclitaxel/topotecan for extensive-stage small cell lung cancer: a Minnie Pearl Cancer Research Network randomized, prospective phase II trial. Greco, FA., Thompson, DS., Morrissey, LH., et al.[2015]

Paclitaxel has shown significant efficacy in treating advanced non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with response rates of 20-25% in NSCLC and over 50% in SCLC, along with median survival times of approximately 40 weeks and 10 months, respectively.

When combined with cisplatin or carboplatin, paclitaxel increases response rates in advanced NSCLC to 39-42% and slightly improves median survival times, demonstrating its potential as a more effective treatment option compared to single-agent therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the role of paclitaxel in lung cancer: summary of recent studies and implications for future directions. Bunn, PA.[2015]

In a study involving 191 patients with advanced non-small-cell lung cancer (NSCLC), ixabepilone did not show any significant improvement in progression-free survival (PFS) or overall survival (OS) compared to paclitaxel, regardless of the tumor's beta-3 tubulin (β3T) expression status.

The presence of β3T expression was associated with worse PFS outcomes, indicating it is a negative prognostic factor in NSCLC, but it did not predict the effectiveness of ixabepilone or paclitaxel treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized phase II study of ixabepilone or paclitaxel plus carboplatin in patients with non-small-cell lung cancer prospectively stratified by beta-3 tubulin status. Edelman, MJ., Schneider, CP., Tsai, CM., et al.[2015]

Ixabepilone is an effective treatment option for patients with metastatic breast cancer who are refractory to taxane therapies, showing activity in clinical trials specifically for this group.

The safety profile of ixabepilone is comparable to that of traditional taxanes, with dose-limiting toxicities primarily including neuropathy and neutropenia, indicating a need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixabepilone: a new chemotherapeutic option for refractory metastatic breast cancer. Puhalla, S., Brufsky, A.[2021]

Nab-PTX (Abraxane®) was administered to 31 breast cancer patients without any allergic reactions, indicating it is well tolerated, even in those with alcohol intolerance.

Among patients with locally advanced operable breast cancer, higher doses (260 mg/m²) resulted in a better response rate, with 10 out of 13 showing a partial response, suggesting its efficacy in treating advanced stages of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical experience of nab-Paclitaxel treatment in 31 patients with breast cancer]. Tauchi, Y., Kashiwagi, S., Ishihara, S., et al.[2015]

In a phase III trial involving 360 patients with advanced non-small-cell lung cancer, the new combination treatment of vinorelbine and paclitaxel showed similar response rates and overall survival compared to the standard carboplatin and paclitaxel treatment.

While both treatments had comparable toxicity profiles, the vinorelbine-paclitaxel combination resulted in significantly higher rates of neutropenia, indicating a potential safety concern with this new regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Front-line paclitaxel-vinorelbine versus paclitaxel-carboplatin in patients with advanced non-small-cell lung cancer: a randomized phase III trial. Stathopoulos, GP., Veslemes, M., Georgatou, N., et al.[2020]

In a study of 458 patients with advanced squamous-cell lung cancer, the nab-paclitaxel-carboplatin (nabpc) regimen showed a significantly longer median overall survival (23.9 months) compared to gemcitabine-platinum (gp) (16.9 months) and sb-paclitaxel-carboplatin (sbpc) (18.3 months).

Despite the differences in overall survival among the first-line treatments, there were no significant differences in progression-free survival or treatment discontinuation rates, and all first-line agents had similar overall survival outcomes in patients who later received second-line immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of first-line treatments in metastatic squamous non-small-cell lung cancer. Levy, BP., Signorovitch, JE., Yang, H., et al.[2022]

A variety of new agents, including taxanes, gemcitabine, and irinotecan, have shown promise in early clinical studies for treating non-small-cell lung cancer (NSCLC), indicating potential for improved treatment options.

Cisplatin remains a key component in combination therapies for NSCLC, being tested alongside these new agents, radiation, and surgery in numerous trials to enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy in metastatic non-small-cell lung cancer. Sandler, A.[2022]

Paclitaxel (TAXOL) has shown promising efficacy in treating lung cancer, with objective response rates of 21% and 24% in patients with non-small cell lung cancer, and a higher response rate of 34% in patients with extensive-stage small cell lung cancer.

Further research is necessary to explore the effectiveness of paclitaxel as a standalone treatment for small cell lung cancer and its potential as a radiosensitizer or in combination with other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of paclitaxel (Taxol) in advanced lung cancer. Ettinger, DS.[2015]

The combination of paclitaxel/carboplatin and bevacizumab significantly increases overall survival in patients with advanced nonsquamous non-small cell lung cancer, with median survival times of 12.3 months for the combination therapy compared to 10.3 months for the chemotherapy alone.

Patients with adenocarcinoma specifically showed an even greater survival benefit from the combination treatment, with a median overall survival of 14.2 months compared to 10.3 months for those receiving only chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment outcomes by tumor histology in Eastern Cooperative Group Study E4599 of bevacizumab with paclitaxel/carboplatin for advanced non-small cell lung cancer. Sandler, A., Yi, J., Dahlberg, S., et al.[2022]

The combination of paclitaxel and vinorelbine was effective as a first-line treatment for untreated patients with metastatic lung adenocarcinoma, with a response rate of 50% and a median survival of 10 months based on a study of 54 patients.

While myelotoxicity was a common side effect affecting 87% of patients, severe neutropenia (grade 4) occurred in only 14.8%, indicating that the treatment regimen was manageable and did not require dose reductions for most patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel and vinorelbine combination in advanced inoperable adenocarcinoma of the lung: a phase II study. Stathopoulos, GP., Veslemes, M., Georgatou, N., et al.[2018]

Ixabepilone, an FDA-approved epothilone B analogue, has shown significant efficacy in treating various solid tumors, particularly in patients with metastatic breast cancer who have become resistant to standard treatments like anthracyclines and taxanes.

In a phase III trial, ixabepilone combined with capecitabine demonstrated superior disease control compared to capecitabine alone in patients with resistant metastatic breast cancer, although treatment is associated with common side effects such as neutropenia and peripheral sensory neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical development of ixabepilone and other epothilones in patients with advanced solid tumors. Rivera, E., Lee, J., Davies, A.[2012]

In a study of 36 patients with extensive-disease small-cell lung cancer (SCLC), paclitaxel demonstrated activity with a 34% partial response rate and a median survival duration of 43 weeks, indicating its potential efficacy as a treatment option.

However, the treatment was associated with significant toxicity, particularly grade 4 leukopenia in 56% of patients, highlighting the need for careful monitoring and consideration of combination therapies to improve safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of paclitaxel in patients with extensive-disease small-cell lung cancer: an Eastern Cooperative Oncology Group study. Ettinger, DS., Finkelstein, DM., Sarma, RP., et al.[2017]

A 55-year-old woman developed corneal disorders, including blurred vision and epithelial defects, after treatment with nab-paclitaxel, indicating that this microtubule inhibitor can cause significant ocular side effects.

After discontinuing nab-paclitaxel, her corneal condition improved dramatically, suggesting that the drug was the likely cause of her symptoms, although the potential contribution of other medications like trastuzumab and pertuzumab should also be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A Case of a Corneal Disorder after Breast Cancer Treatment with Nab-paclitaxel]. Hosotani, Y., Morimatsu, T., Takata, M., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06016270

NCT06016270 | A Study of hSTC810 in Combination With ... The purpose of this clinical study is to assess the safety and efficacy of hSTC810 and paclitaxel combination therapy in patients with relapsed or refractory ...

2. sigma.larvol.com sigma.larvol.com/product.php?e1=909272&tab=newstrac

nelmastobart (STT-003) News Conclusions : Preliminary results from the TMA analysis and Phase 1 trial suggest that targeting BTN1A1 with Nelmastobart is safe and shows early signs of ...

3. synapse.patsnap.com synapse.patsnap.com/drug/69d449a50b434f4c9a88bb477ef95ee1

Nelmastobart - Drug Targets, Indications, Patents Anti STT-003 Ab, Anti-butyrophilin 1A1 mAb(STCube/MD Anderson Cancer Center) ... A Phase Ib/II Study of hSTC810 in Combination With Paclitaxel in Relapsed or ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7293099/

Five‐year safety and efficacy data from a phase Ib study ... Carboplatin/paclitaxel/bevacizumab plus nivolumab showed the highest response rate of the 3 arms in the first‐line setting, and had a relatively large number of ...

5. ar.iiarjournals.org ar.iiarjournals.org/content/42/10/4921

Efficacy and Safety of Paclitaxel/nab- ... Treatment with PTX or nab-PTX is effective and tolerable for patients with relapsed SCLC, including those with interstitial lung disease.

6. asco.org asco.org/abstracts-presentations/ABSTRACT410056

A phase I study of nelmastobart (hSTC810), an anti- ... This phase I study describes the safety and clinical activity of Nelmastobart (hSTC810) ... Current data show evidence of anti-tumor activity and durable SD.

7. delta.larvol.com delta.larvol.com/Products/?ProductId=b8404f74-e88a-4af5-8931-baaf10746a22

nelmastobart (STT-003) / STCube Pharma ... Lung Cancer: Findings From a Phase 1 Trial ... A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer ...