hSTC810 + Paclitaxel for Lung Cancer

Recruiting at 7 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

130 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug (hSTC810) combined with an existing chemotherapy drug (paclitaxel) in patients whose lung cancer has returned or did not respond to previous treatments. The goal is to determine if this combination is safe and effective. Paclitaxel is a well-known chemotherapy drug used to treat lung cancer and has been used in various combinations to improve treatment outcomes and survival times.

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.

What data supports the effectiveness of the drug hSTC810 + Paclitaxel for lung cancer?

Research shows that paclitaxel, when combined with other drugs like carboplatin, can improve survival in patients with advanced non-small cell lung cancer. This suggests that paclitaxel is effective in treating certain types of lung cancer. ^{1 2 3 4 5}

Is the combination of hSTC810 and Paclitaxel safe for humans?

Paclitaxel, also known as Abraxane, has been used in various cancer treatments and is generally well tolerated, though it can cause side effects like sensory neuropathy (nerve damage causing tingling or numbness) and, in rare cases, corneal disorders (eye issues). There is no specific safety data available for hSTC810, but Paclitaxel's safety profile is well-documented in cancer treatments. ^{6 7 8 9 10}

What makes the drug hSTC810 + Paclitaxel unique for lung cancer treatment?

The combination of hSTC810 and Paclitaxel is unique because it involves a novel antibody treatment (hSTC810) that targets specific proteins in cancer cells, potentially enhancing the effectiveness of Paclitaxel, a well-established chemotherapy drug for lung cancer. This combination may offer a new approach by potentially improving response rates and survival times compared to existing treatments. ^{1 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Paclitaxel and vinorelbine combination in advanced inoperable adenocarcinoma of the lung: a phase II study. [2018]

2. United States 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. [2022]

3. England 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. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of first-line treatments in metastatic squamous non-small-cell lung cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States 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. [2015]

7. Japan pubmed.ncbi.nlm.nih.gov

[A Case of a Corneal Disorder after Breast Cancer Treatment with Nab-paclitaxel]. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Clinical development of ixabepilone and other epothilones in patients with advanced solid tumors. [2012]

9. Japan pubmed.ncbi.nlm.nih.gov

[Clinical experience of nab-Paclitaxel treatment in 31 patients with breast cancer]. [2015]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Ixabepilone: a new chemotherapeutic option for refractory metastatic breast cancer. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. England 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. [2015]

13. United States pubmed.ncbi.nlm.nih.gov

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

14. United States 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. [2017]