hSTC810 + Paclitaxel for Lung Cancer
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: STCube, Inc.
Must not be taking: Immunotherapy, Chemotherapy, Steroids, others
Disqualifiers: CNS metastases, Autoimmune disease, Hepatitis, others
No Placebo Group
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.
12345Is 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.
678910What 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.
111121314Eligibility 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.
+6 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: hSTC810 800 mg + PaclitaxelExperimental Treatment1 Intervention
hSTC810 800 mg will be administered with a standard dose of paclitaxel
Group II: hSTC810 400 mg + PaclitaxelExperimental Treatment1 Intervention
hSTC810 400 mg will be administered with a standard dose of paclitaxel
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
Tisch Cancer Institute at Mount SinaiNew York, NY
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Who Is Running the Clinical Trial?
STCube, Inc.Lead Sponsor
References
Paclitaxel and vinorelbine combination in advanced inoperable adenocarcinoma of the lung: a phase II study. [2018]The purpose of this study was to determine the efficacy of paclitaxel (PCT) combined with vinorelbine (VRL) in adenocarcinoma of the lung.
Treatment outcomes by tumor histology in Eastern Cooperative Group Study E4599 of bevacizumab with paclitaxel/carboplatin for advanced non-small cell lung cancer. [2022]The combination of paclitaxel/carboplatin (PC) and bevacizumab (B) was previously shown to extend overall survival (OS) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC). An analysis of survival and safety outcomes based on histology is presented here.
Front-line paclitaxel-vinorelbine versus paclitaxel-carboplatin in patients with advanced non-small-cell lung cancer: a randomized phase III trial. [2020]This randomized phase III trial of advanced or metastatic non-small-cell lung cancer (NSCLC) was designed to compare a standard treatment such as carboplatin (CRP)-paclitaxel (PCT) with a new combination, vinorelbine (VRL)-PCT-two agents acting in microtubules.
Effectiveness of first-line treatments in metastatic squamous non-small-cell lung cancer. [2022]Commonly used first-line (1L) chemotherapies for patients with advanced squamous-cell lung cancer (scc) include gemcitabine-platinum (gp), nab-paclitaxel-carboplatin (nabpc), and sb-paclitaxel-carboplatin (sbpc) regimens. However, no head-to-head trials have compared those treatments. In the present study, we compared the efficacy of 1L gp, nabpc, and sbpc in patients with scc and in patients with scc who subsequently received second-line (2L) immunotherapy.
Chemotherapy in metastatic non-small-cell lung cancer. [2022]Over the last decade, a group of new agents with differing mechanisms of action have shown great promise in early clinical studies in non-small-cell lung cancer (NSCLC). These include the taxanes docetaxel (Taxotere) and paclitaxel (Taxol); the nucleoside analog gemcitabine (Gemzar); the vinca alkaloid vinorelbine (Navelbine); the topoisomerase-I inhibitor irinotecan (Camptosar, CPT-11); and the bioreductive agent tirapazamine. Cisplatin (Platinol), which has been the "backbone" of combination chemotherapy in patients with NSCLC because of its proven single-agent activity, has been examined in combination with these agents as well as radiation and surgery in numerous trials. This article summarizes trials of these combination therapies in the treatment of NSCLC.
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]Retrospective studies have reported that tumor expression of the beta-3 tubulin (β3T) isoform is an unfavorable prognostic factor in non-small-cell lung cancer (NSCLC) treated with tubulin-inhibiting chemotherapy. Ixabepilone is a tubulin-inhibiting agent with low susceptibility to multiple resistance mechanisms including β3T isoform expression in several tumor models. This randomized phase II study evaluated ixabepilone-based chemotherapy in stage IIIb/IV NSCLC, compared with paclitaxel-based chemotherapy. Tumor specimens were prospectively evaluated for β3T expression.
[A Case of a Corneal Disorder after Breast Cancer Treatment with Nab-paclitaxel]. [2016]We report a case of a corneal disorder after breast cancer treatment with a microtubule inhibitor, nab-paclitaxel (Abraxane).
Clinical development of ixabepilone and other epothilones in patients with advanced solid tumors. [2012]Chemotherapy efficacy in patients with solid tumors is influenced by primary and acquired multidrug resistance (MDR). Epothilones represent a novel class of microtubule inhibitors with lower susceptibility to drug resistance and efficacy in taxane-resistant tumors. While other epothilones are currently under investigation, ixabepilone is the first epothilone B analogue approved by the U.S. Food and Drug Administration. Ixabepilone has been shown to have preclinical activity in chemotherapy-sensitive and chemotherapy-resistant tumor models, and synergistic antitumor activity with other chemotherapeutic and targeted agents. Single-agent ixabepilone has demonstrated clinical activity in multiple solid tumors including advanced breast, lung, prostate, pancreatic, renal cell, and ovarian cancers. Most notably, efficacy has been demonstrated in patients with metastatic breast cancer (MBC) progressing after treatment with anthracyclines and taxanes. A phase III trial in anthracycline- and taxane-resistant MBC showed superior disease control with ixabepilone plus capecitabine versus capecitabine monotherapy, resulting in its approval. Ixabepilone is also active in chemotherapy-naïve and taxane-resistant hormone-refractory prostate cancer and platinum-resistant non-small cell lung cancer. Neutropenia and peripheral sensory neuropathy are the most common adverse events associated with treatment. This review discusses the challenges of MDR and the data that support the use of epothilones in this setting, focusing on ixabepilone.
[Clinical experience of nab-Paclitaxel treatment in 31 patients with breast cancer]. [2015]Nanoparticle albumin-bound paclitaxel (nab-PTX, Abraxane®) does not require premedication, and it can be used for patients with alcohol intolerance. We administered nab-PTX to 31 patients with breast cancer between October 2010 and April 2013. Eighteen patients had progressive, recurring breast cancers and 13 patients had locally advanced operable breast cancers. The treatment schedules were 175 or 260 mg/m² every 3 weeks (q3w). No patient experienced an allergic reaction. Grade 1-3 sensory neuropathies were observed in 20 patients; however, no patient experienced grade 4 neuropathy. In patients with locally advanced, operable breast cancer, 1 patient treated with 175 mg/m² q3w had a partial response (PR), while of the patients treated with 260 mg/m² q3w, 10 patients showed a PR, and 1 patient had stable disease (SD). Of the patients with progressive, recurring breast cancer, 2 patients showed a PR and 4 patients had SD when treated with 175 mg/m² q3w, whereas 1 patient displayed a PR and 1 patient had SD when treated with 260 mg/m² q3w. Our investigation suggests that nab-PTX is well tolerated, even by patients with advanced breast cancer.
Ixabepilone: a new chemotherapeutic option for refractory metastatic breast cancer. [2021]Taxane therapy is commonly used in the treatment of metastatic breast cancer. However, most patients will eventually become refractory to these agents. Ixabepilone is a newly approved chemotherapeutic agent for the treatment of metastatic breast cancer. Although it targets microtubules similarly to docetaxel and paclitaxel, ixabepilone has activity in patients that are refractory to taxanes. This review summarizes the pharmacology of ixapebilone and clinical trials with the drug both as a single agent and in combination. Data were obtained using searches of PubMed and abstracts of the annual meetings of the American Society of Clinical Oncology and the San Antonio Breast Cancer Symposium from 1995 to 2008. Ixapebilone is a semi-synthetic analog of epothilone B that acts to induce apoptosis of cancer cells via the stabilization of microtubules. Phase I clinical trials have employed various dosing schedules ranging from daily to weekly to 3-weekly. Dose-limiting toxicites included neuropathy and neutropenia. Responses were seen in a variety of tumor types. Phase II studies verified activity in taxane-refractory metastatic breast cancer. The FDA has approved ixabepilone for use as monotherapy and in combination with capecitabine for the treatment of metastatic breast cancer. Ixabepilone is an efficacious option for patients with refractory metastatic breast cancer. The safety profile is similar to that of taxanes, with neuropathy and neutropenia being dose-limiting. Studies are ongoing with the use of both iv and oral formulations and in combination with other chemotherapeutic and biologic agents.
Overview of paclitaxel (Taxol) in advanced lung cancer. [2015]Paclitaxel (TAXOL), a novel diterpene plant product isolated from the western yew Taxus brevifolia, is an active agent in the treatment of lung cancer. In two studies, the drug produced 21% and 24% objective response rates among patients with non-small cell lung cancer. A response rate of 34% was reported in a single trial involving patients with extensive-stage small cell lung cancer. Additional trials are needed to evaluate single-agent paclitaxel in the treatment of small cell lung cancer. Studies also are planned to measure the effect of paclitaxel as a radiosensitizer and in combination regimens with other active agents for the treatment of lung cancer.
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]To compare the combination of paclitaxel (Taxol; Bristol-Myers Squibb, Princeton, NJ, http://www.bms.com) and topotecan (Hycamtin; Glaxo SmithKline, Philadelphia, http://www.gsk.com) with paclitaxel, carboplatin (Paraplatin; Bristol-Myers Squibb), and etoposide (Etopophos, VePesid; Bristol-Myers Squibb) in patients with previously untreated extensive-stage small cell lung cancer.
Defining the role of paclitaxel in lung cancer: summary of recent studies and implications for future directions. [2015]Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) was first reported to have activity in advanced non-small cell lung cancer (NSCLC) in 1993 and in advanced small cell lung cancer (SCLC) in 1995. Since these original reports, single-agent activity has been confirmed in both NSCLC and SCLC. In NSCLC, the 20% to 25% response rate and median survival times (approximately 40 weeks) are superior to previously reported single-agent therapy. In SCLC, the response rate (> or =50%) and median survival (10 months) are similar to the best previously reported agents. Paclitaxel can be combined safely with both cisplatin and carboplatin. In advanced NSCLC, these two drug combinations produce higher response rates (39% to 42%) than either drug alone. The median survival times reported with the combinations (39 to 45 weeks) are slightly longer than with single-agent paclitaxel. Paclitaxel and cisplatin combinations were shown to be superior to cisplatin and podophyllotoxin combinations in randomized trials. Paclitaxel and paclitaxel plus carboplatin combinations can be safely combined with chest radiotherapy in patients with stage III NSCLC. Response rates and survival times are at least as good as prior best therapies and the results of randomized trials are eagerly awaited. Similarly, paclitaxel and carboplatin combinations produce high response rates when given before surgery for operable patients, and the results of randomized trials are needed to confirm the value of this approach. Paclitaxel-based combinations in advanced SCLC can be administered safely and provide high response rates and relatively long survival times. Randomized trials comparing these combinations to older etoposide/cisplatin combinations are in progress.
Phase II study of paclitaxel in patients with extensive-disease small-cell lung cancer: an Eastern Cooperative Oncology Group study. [2017]To evaluate the efficacy and safety of paclitaxel (Taxol; Bristol-Myers Squibb Co, Princeton, NJ), a novel diterpene plant product in the treatment of previously untreated patients with extensive-disease small-cell lung cancer (SCLC).