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TUB-030 · 1 trial · 6 indications
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
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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 |
Inclusion Criteria: 1. Male or non-pregnant, non-breastfeeding female aged 18 years or older 2. Adequate organ function 3. Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
TUB-030 is an investigational small molecule antibody-drug conjugate being developed by Gilead Sciences, Inc. for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and is not yet approved for any indication. The program is evaluating TUB-030 in a first-in-human study across several tumor types.
TUB-030 is being studied for advanced solid tumors, including head and neck squamous cell carcinoma, small cell lung cancer, non-small cell lung cancer, triple-negative breast cancer, and colorectal cancer. It is investigational and has not been approved for any use. All evaluation to date is within a Phase 1 clinical trial.
TUB-030 targets 5T4, a tumor-associated antigen, and is designed as an antibody-drug conjugate. The 5T4 target is expressed on several solid tumor types, which is the basis for studying TUB-030 across the cancer indications in its clinical program. Gilead Sciences is developing the asset.
Gilead Sciences, Inc. is developing TUB-030. The company trades on the Nasdaq under the ticker GILD. Gilead is running the Phase 1 first-in-human study of TUB-030 in patients with advanced solid tumors.
TUB-030 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The ongoing first-in-human study is designed to evaluate the drug in patients with advanced solid tumors.
TUB-030 is being evaluated in the first-in-human study NCT06657222, titled First in Human Study of TUB-030 in Patients With Advanced Solid Tumors. The trial is recruiting, with an enrollment of 250 participants across the United States, Canada, France, Romania, and Spain. It is a controlled Phase 1 study in adults aged 18 years and older.