TUB-030 for Cancer

Recruiting at 14 trial locations

Overseen By Tubulis Clinical Trial Inquiries

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Tubulis GmbH

Disqualifiers: Pregnancy, Breastfeeding, others

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

Compensation: Varies

Number of Visits: 6

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, TUB-030, to determine its safety and effectiveness for treating solid cancers, specifically head and neck cancer and non-small cell lung cancer. Researchers aim to find the optimal dose and ensure patient safety. Participants will receive the drug every three weeks and complete questionnaires about their symptoms. Suitable candidates include those with solid cancers who have tried other treatments and have stable health following any brain radiation therapy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that TUB-030 is likely to be safe for humans?

Earlier research on TUB-030 has shown promising results. Studies have highlighted its strong ability to shrink tumors, even at low doses, offering hope for potential benefits. However, safety considerations are important.

Since TUB-030 remains in early testing stages, limited information exists about its safety in humans. These early trials aim to find the best dose while monitoring for side effects. Researchers are still assessing how well people can tolerate it. Some side effects may occur, but the exact risks remain unclear.

For those considering joining the trial, discussing with a doctor is crucial. They can help weigh the potential benefits and risks based on individual circumstances. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Unlike the standard treatments for cancers like non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC), which often include chemotherapy, radiation, and targeted therapies, TUB-030 is administered via intravenous infusion and focuses on dose optimization. Researchers are excited about TUB-030 because it introduces a potentially new active ingredient with a novel mechanism of action that could improve effectiveness and safety profiles. Additionally, its unique approach in dose optimization aims to tailor treatment more precisely to individual patient needs, potentially enhancing outcomes and minimizing side effects. This could mark a significant advancement in personalized cancer therapy.

What evidence suggests that TUB-030 might be an effective treatment for solid cancer?

Research has shown that TUB-030 could effectively treat solid cancers. Early studies found that TUB-030 can shrink tumors and prevent them from regrowing for extended periods, even at low doses. This treatment targets a protein called 5T4, present on many cancer cells. TUB-030 demonstrated strong anti-tumor effects in various lab tests, suggesting it might also work well in people. In this trial, participants will receive TUB-030 in different doses to evaluate its effectiveness against head and neck cancer and non-small cell lung cancer. These early results offer hope for its potential in these specific cancers. ^{1 2 4 6 7}

Who Is on the Research Team?

Gunter Fingerle-Rowson, MD, PhD

Principal Investigator

Tubulis GmbH

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06657222

NCT06657222 | First in Human Study of TUB-030 ... 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.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS3164

TUB-030, a novel ADC targeting 5T4: A phase I/IIa multi- ... Preclinical studies demonstrated potent anti-tumor activity, including long-lasting tumor regression at doses as low as 1 mg/kg and durable ...

3. fredhutch.org fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15429.first-in-human-study-of-tub-030-in-patients-with-advanced-solid-tumors.html

First in Human Study of TUB-030 in Patients ... 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 ...

4. tubulis.com tubulis.com/news/tubulis-presents-preclinical-data-for-solid-tumor-targeting-adc-candidates-tub-030-and-tub-040-demonstrating-superior-efficacy-profile-and-a-wide-therapeutic-window-at-the-aacr-annual-meeting-2024/

TUB-030 and TUB-040 demonstrate ... TUB-030 and TUB-040 demonstrate high and long-lasting anti-tumor efficacy in a range of preclinical models; TUB-030 is directed against the ...

5. withpower.com withpower.com/trial/phase-2-breast-neoplasms-11-2024-7d1b6?condition=small+cell+lung+cancer&hasNoPlacebo=false&overallStatus=Recruiting

TUB-030 for Cancer · Recruiting Participants for Phase ... 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.

6. delta.larvol.com delta.larvol.com/Products/?ProductId=8913baeb-a18a-449d-962f-525e971f7058

TUB-030 / Tubulis TUB-030, a Novel Adc: A Phase I/IIA Multi-Center, FIH Trial (5-STAR 1-01) in Patients With Advanced/Metastatic Solid Tumors (IASLC-WCLC 2025) - P1/2 ...

7. researchgate.net researchgate.net/publication/392300091_TUB-030_a_novel_ADC_targeting_5T4_A_phase_IIIa_multi-center_first-in-human_clinical_trial_5-STAR_1-01_in_patients_with_advanced_solid_tumors

TUB-030, a novel ADC targeting 5T4: A phase I/IIa multi- ... Preclinical studies demonstrated potent anti-tumor activity, including long-lasting tumor regression at doses as low as 1 mg/kg and durable responses even in ...