TUB-030 for Cancer

Recruiting at 2 trial locations

Overseen By Tubulis Clinical Trial Inquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Tubulis GmbH

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

Compensation: Varies

Number of Visits: 6

130 Participants Needed

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. ^{1 2 3 4 5}

Research Team

Gunter Fingerle-Rowson, MD, PhD

Principal Investigator

Tubulis GmbH

Eligibility 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.

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

Treatment Details

Interventions

• TUB-030

Trial Overview 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.

Participant Groups

Group I: Phase 2: dose optimization in NSCLC and HNSCC Experimental Treatment 1 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 escalation Experimental Treatment 1 Intervention

Drug TUB-030, administered by intravenous (IV) infusion

Who Is Running the Clinical Trial?

Tubulis GmbH

Lead Sponsor

Trials

2

Recruited

230+

Findings from Research

In a review of five phase III clinical trials, docetaxel was associated with a higher incidence of grade 3/4 neutropenia compared to paclitaxel, indicating a distinct safety profile for each taxane.

Paclitaxel was more likely to cause peripheral neuropathy, while docetaxel had higher rates of gastrointestinal adverse events, suggesting that the choice of taxane may depend on the patient's tolerance to these specific side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systemic review of taxanes and their side effects in metastatic breast cancer. Lai, JI., Chao, TC., Liu, CY., et al.[2022]

Lipusu, a new liposome-based formulation of paclitaxel, showed a significantly better safety profile than Taxol, as it did not induce hypersensitivity reactions or related lung lesions in animal studies.

Both Lipusu and Taxol demonstrated similar anti-proliferative effects against human cancer cells, suggesting that Lipusu could be a safer alternative for cancer treatment without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypersensitivity reaction studies of a polyethoxylated castor oil-free, liposome-based alternative paclitaxel formulation. Wang, H., Cheng, G., Du, Y., et al.[2021]

CPC634, a nanoparticle formulation of docetaxel, leads to significantly higher total docetaxel concentrations in the skin (369% more) compared to conventional docetaxel, indicating enhanced skin exposure to the drug.

Both CPC634 and conventional docetaxel cause similar cutaneous anti-mitotic effects, such as increased apoptosis and skin toxicity, suggesting that while CPC634 may improve drug delivery, it also carries a risk of similar side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel Skin Exposure and Micronucleation Contributes to Skin Toxicity Caused by CPC634. Atrafi, F., van Eerden, RAG., Koolen, SLW., et al.[2021]

Paclitaxel has shown promising efficacy in treating metastatic bladder cancer, with a 42% overall response rate and a 27% complete response rate in a phase II trial involving previously untreated patients.

The treatment was well tolerated, with less than 10% of patients experiencing neutropenic fever, suggesting a favorable safety profile, especially when supported by granulocyte colony-stimulating factor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of paclitaxel in the therapy of bladder cancer. Roth, BJ.[2015]

Paclitaxel shows a response rate of 40-50% as a single agent in metastatic bladder cancer and is highly effective in combination therapies, achieving remission rates above 70% when combined with cisplatin or ifosfamide.

Paclitaxel is safe for patients with reduced renal function, requiring no dose adjustments and not increasing toxicity, making it a promising option for first-line chemotherapy in bladder cancer and salvage therapy in testicular cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of paclitaxel in chemosensitive urological malignancies: current strategies in bladder cancer and testicular germ-cell tumors. Bokemeyer, C., Hartmann, JT., Kuczyk, MA., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A systemic review of taxanes and their side effects in metastatic breast cancer. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Hypersensitivity reaction studies of a polyethoxylated castor oil-free, liposome-based alternative paclitaxel formulation. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Docetaxel Skin Exposure and Micronucleation Contributes to Skin Toxicity Caused by CPC634. [2021]

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

The role of paclitaxel in the therapy of bladder cancer. [2015]

5. Germany pubmed.ncbi.nlm.nih.gov

The role of paclitaxel in chemosensitive urological malignancies: current strategies in bladder cancer and testicular germ-cell tumors. [2020]