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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: dose escalation | Experimental | Drug TUB-030, administered by intravenous (IV) infusion |
|
| Phase 2: dose optimization in NSCLC and HNSCC | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TUB-030 | Drug | A complete treatment cycle is defined as 21 calendar days. TUB-030 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of MTD | The highest dose is defined at which no more than 1 of 3 patients have had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria | From enrollment until 30 days after last study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Adverse Events (AE) | Any medical event in a participant which may or may not have a causal relationship with this treatment. | From enrollment until 30 days after last study drug |
| Maximum concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tubulis Clinical Trial Inquiries | Contact | +491758005594 | ct-inquiries@tubulis.com |
| Name | Affiliation | Role |
|---|---|---|
| Yariv Houvras, MD, PhD | Tubulis GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States | |
| University of Miami |
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The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
| From enrollment until 30 days after last study drug |
| Trough concentration (Cmin) | The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Cmin will be derived). | From enrollment until 30 days after last study drug |
| The time taken to reach the maximum concentration (Tmax) | The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Tmax will be derived). | From enrollment until 30 days after last study drug |
| Area Under Curve (AUC) | PK endpoint | From enrollment until 30 days after last study drug |
| Half life (T1/2) | PK endpoint | From enrollment until 30 days after last study drug |
| Determination of immunogenicity | Number and percentage of patients developing anti-TUB-030 antibodies | From enrollment until 30 days after last study drug |
| Determination of efficacy | ORR by investigator assest Recist 1.1 | From enrolment until 30 days after last study drug. |
| Recruiting |
| Miami |
| Florida |
| 33136 |
| United States |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| Washington University | Recruiting | St Louis | Missouri | 63130 | United States |
| Mount Sinai | Recruiting | New York | New York | 11766 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
| NEXT Oncology Austin | Recruiting | Austin | Texas | 78758 | United States |
| NEXT Oncology - Dallas | Recruiting | Irving | Texas | 75039 | United States |
| NEXT Oncology - San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
| Princess Margaret | Recruiting | Toronto | Canada |
| Arensia Exploratory Medicine | Recruiting | Bucharest | Romania |
| Arensia Exploratory Medicine | Recruiting | Cluj-Napoca | Romania |
| Clinica Uni de Navara | Recruiting | Madrid | Spain |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D064726 | Triple Negative Breast Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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