TUB-030 for Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Tubulis GmbH
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are:
To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose.
Participants will:
Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it does require that any previous anti-cancer treatments be stopped at least 4 weeks before starting the trial. It's best to discuss your specific medications with the trial team.
What safety data exists for TUB-030 or similar treatments in humans?
Paclitaxel, a drug similar to TUB-030, has been studied for safety in various cancers. It can cause side effects like neutropenia (low white blood cell count), neurotoxicity (nerve damage), and fatigue, but these are generally manageable. A new formulation, Lipusu, shows a better safety profile with fewer hypersensitivity reactions.
12345Eligibility Criteria
This trial is for adults with advanced solid tumors, including specific cancers like breast cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and small cell lung cancer. Participants must be able to visit the clinic every three weeks and complete questionnaires about their symptoms.Inclusion Criteria
Have a life expectancy of >12 weeks for disease-related mortality
My organs are working well.
I am able to understand and willing to sign the consent form.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Participants receive TUB-030 via IV infusion to determine the maximum tolerated dose
Varies
Every 3 weeks
Dose Optimization
Participants receive TUB-030 via IV infusion to optimize dosing for NSCLC and HNSCC
Varies
Every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The drug TUB-030 is being tested for its effectiveness in treating various solid tumors. The study will determine the safest high dose of TUB-030 when given alone. It will also assess how well it works specifically on head and neck as well as non-small cell lung cancers.
2Treatment groups
Experimental Treatment
Group I: Phase 2: dose optimization in NSCLC and HNSCCExperimental Treatment1 Intervention
Drug TUB-030, administered by intravenous (IV) infusion NSCLC Cohort: Patients will be randomized to receive one of two doses administered by IV infusion HNSCC Cohort: Patients will be randomized to receive one of two doses administered by IV infusion
Group II: Phase 1: dose escalationExperimental Treatment1 Intervention
Drug TUB-030, administered by intravenous (IV) infusion
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NEXT Oncology AustinAustin, TX
NEXT Oncology - DallasIrving, TX
NEXT Oncology - San AntonioSan Antonio, TX
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Who Is Running the Clinical Trial?
Tubulis GmbHLead Sponsor
References
A systemic review of taxanes and their side effects in metastatic breast cancer. [2022]Taxanes-containing chemotherapy constitutes an essential backbone for both early and metastatic breast cancer (mBC). However, the two major taxane drugs-paclitaxel and docetaxel-have distinct safety profiles. In this review, we summarize the safety outcome and management following treatment with both taxanes from selected clinical trials. We utilized PubMed to perform literature search before April 2021. Five phase III randomized controlled trials with reports of individual taxane adverse events (AEs) were included in this review. Grade 3/4 AEs were summarized and discussed extensively. The rates of grade 3/4 neutropenia were higher with docetaxel than with paclitaxel. For non-hematologic grade 3/4 AEs, peripheral neuropathy was more frequent with paclitaxel while fluid retention was more frequent with docetaxel. Compared to paclitaxel, docetaxel had a higher rate of grade 3/4 gastrointestinal AEs. Grade 3/4 myalgia were generally comparable between the two taxanes. Except for neutropenia, the incidence rate of grade 3/4 AEs of taxanes was generally manageable. Peripheral neuropathy was more common with paclitaxel while grade 3/4 neutropenia was more common with docetaxel.
Hypersensitivity reaction studies of a polyethoxylated castor oil-free, liposome-based alternative paclitaxel formulation. [2021]The commercial drug paclitaxel (Taxol) may introduce hypersensitivity reactions associated with the polyethoxylated castor oil-ethanol solvent. To overcome these problems, we developed a polyethoxylated castor oil-free, liposome-based alternative paclitaxel formulation, known as Lipusu. In this study, we performed in vitro and in vivo experiments to compare the safety profiles of Lipusu and Taxol, with special regard to hypersensitivity reactions. First, Swiss mice were used to determine the lethal dosages, and then to evaluate hypersensitivity reactions, followed by histopathological examination and enzyme-linked immunosorbent assays (ELISAs) of serum SC5b-9 and lung histamine. Additionally, healthy human serum was used to analyze in vitro complement activation. Finally, an MTT assay was used to determine the in vitro anti-proliferation activity. Our data clearly showed that Lipusu displayed a much higher safety margin and did not induce hypersensitivity or hypersensitivity-related lung lesions, which may be associated with the fact that Lipusu did not activate complement or increase histamine release in vivo. Moreover, Lipusu did not promote complement activation in healthy human serum in vitro, and demonstrated anti-proliferative activity against human cancer cells, similar to that of Taxol. Therefore, the improved formulation of paclitaxel, which exhibited a much better safety profile and comparable cytotoxic activity to Taxol, may bring a number of benefits to cancer patients.
Docetaxel Skin Exposure and Micronucleation Contributes to Skin Toxicity Caused by CPC634. [2021]Docetaxel entrapped nanoparticle CPC634 is associated with dose-related skin toxicity that resembles conventional docetaxel (Cd)-related skin toxicity. This study compared the cutaneous pharmacokinetics and pharmacodynamics of docetaxel and CPC634. In this randomised cross-over study, patients with solid tumours received one cycle of CPC634 and Cd (both at 75 mg/m2). Skin biopsies were taken at baseline and at day 8 of both cycles. Released and total docetaxel (released docetaxel plus entrapped docetaxel) concentrations and histopathological changes in the skin biopsies were evaluated. Twenty patients underwent paired skin biopsies for pharmacokinetic analysis and 10 patients had biopsies available for histopathological assessment. The total skin docetaxel concentration was 369% (95%CI: 229% to 569%, p < 0.001) higher after CPC634 administration compared to Cd while the released docetaxel concentrations were not statistically different (95%CI: -9% to 63%, p = 0.169). The CPC634 released docetaxel concentration in the skin was positively correlated with plasma concentrations (Pearson's correlation 0.48, p = 0.03). Histopathological examination revealed increased apoptosis, mitotic cells with nuclear atypia, and micronucleation with an enhanced Ki-67 index for both compounds. In conclusion, both CPC634 and Cd treatment result in docetaxel exposure in the skin causing cutaneous anti-mitotic effects such as micronucleation, which could induce an inflammatory reaction leading to skin toxicity.
The role of paclitaxel in the therapy of bladder cancer. [2015]Although significant strides have been made in the development of effective chemotherapy for metastatic bladder cancer, those benefits have plateaued and prompted a search for new, active agents. The most active of a new generation of investigational agents is paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ). The only single-agent phase II trial to date, which used paclitaxel at a dose of 250 mg/m2 by 24-hour infusion every 3 weeks, resulted in a 42% response rate and a 27% complete response rate in previously untreated patients. With granulocyte colony-stimulating factor support, this therapy was well tolerated, with fewer than 10% of patients developing neurtropenic fever during therapy. Paclitaxel's potential as a radiation sensitizer and its relatively low renal excretion make it an attractive agent for use in patients with urothelial carcinoma. The goal of ongoing and planned clinical trials will be to (1) identify potential paclitaxel-containing combination regimens, (2) define the optimal dose and schedule of administration in patients with bladder cancer, and (3) define the activity of paclitaxel in previously treated patients.
The role of paclitaxel in chemosensitive urological malignancies: current strategies in bladder cancer and testicular germ-cell tumors. [2020]Recent results demonstrate an emerging role for paclitaxel in patients with urothelial-tract cancer and in patients with testicular cancer. Yielding response rates in the range of 40-50% as a single agent, paclitaxel is one of the most active drugs in metastatic bladder cancer. Ongoing trials of paclitaxel combination chemotherapy with cisplatin or cisplatin and ifosfamide demonstrate substantial objective remission rates above 70% and, in addition, a high range of complete responses. Thus, paclitaxel appears to be an important drug when used as part of first-line combination chemotherapy for metastatic bladder cancer. Ongoing clinical trials focus on the combination of paclitaxel with cisplatin, ifosfamide, gemcytabine, and carboplatin. Furthermore, paclitaxel administration has been demonstrated to be easily applicable to patients with reduced renal function, requiring no dose reduction and producing no increase in toxicity. Future strategies will have to compare the most active paclitaxel combination regimen with first-line MVAC (methotrexate, vinblastine, adriamycin, cisplatin) chemotherapy. Finally, the role of paclitaxel combination regimens needs to be explored in the adjuvant and neoadjuvant setting in patients with bladder cancer. In testicular cancer, paclitaxel has initially been tested in patients with cisplatin-refractory disease. Among 4 consecutive trials involving a total of 83 patients a response rate of 26% has been observed using dose schedules varying from 3-h to 24-h infusions and doses ranging from 175 to 250 mg/m2. The major toxicities of paclitaxel include neutropenia, neurotoxicity, and fatigue syndrome. Currently, combinations of paclitaxel with cisplatin +/- ifosfamide are used as first- or second-line salvage therapy in patients with relapsed metastatic testicular cancer. The German Testicular Cancer Study Group uses a paclitaxel (Taxol, ifosfamide, cisplatin; TIP) combination regimen as salvage treatment. Following the TIP regimen and the application of granulocyte colony-stimulating factor (G-CSF), peripheral blood stem cells (PBSC) are harvested and the patients subsequently receive high-dose chemotherapy with PBSC rescue. Since only a few drugs have demonstrated substantial activity in cisplatin-refractory disease, paclitaxel will be used in early salvage strategies and, possibly, as first-line chemotherapy as a part of platinum-based combination regimens in patients with testicular cancer. Further trials confirming the important role of paclitaxel in this highly curable malignancy and a thorough investigation of its acute and long-term toxicity will be the future tasks.