Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TUB-040 - Dose escalation, TUB-040
TUB-040- Dose escalation · 4 trials · 5 indications
Incidence and severity of treatment-emergent adverse events (TEAEs)
Assessment of overall response rate (ORR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1 as assessed by the investigator (INV)
Incidence and severity of treatment-emergent adverse events (TEAEs)
Incidence of dose-limiting toxicities (DLTs) at each dose level
Investigator (INV) assessment of overall response rate (ORR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1
Occurrence and severity of treatment-emergent adverse events (TEAEs)
Occurrence of DLTs (Dose limiting toxicities) at different dose levels (during first treatment cycle)
ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR), as assessed by BICR.
| Arm | Type | Description |
|---|---|---|
| NSCLC Dose 1 | EXPERIMENTAL | Participants will receive TUB-040 administered as an intravenous (IV) infusion on Day 1 of each treatment cycle. Until disease progression, unacceptable toxicity, or withdrawal of consent. |
| NSCLC Dose 2 | EXPERIMENTAL | Participants will receive TUB-040 administered as an IV infusion on Day 1 of each treatment cycle. Until disease progression, unacceptable toxicity, or withdrawal of consent. |
| Phase 1: Dose Escalation of TUB-040 | EXPERIMENTAL | Participants will receive escalating doses of TUB-040 to determine recommended Phase 2 dose (RP2D). |
| Phase 2: Monotherapy of TUB-040 | EXPERIMENTAL | Participants in Phase 2 will receive the recommended dose of TUB-040 monotherapy determined in Phase |
| Phase 1b Dose Escalation | EXPERIMENTAL | Drug TUB-040 administered in combination with carboplatin (Carbo) and bevacizumab (BEV) |
| Platinum resistant ovarian cancer | EXPERIMENTAL | - |
| Non small cell lung cancer-adenocarcinoma | EXPERIMENTAL | - |
| Platinum resistant ovarian cancer in combination with Bevacizumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TUB-040 | DRUG | Administered IV |
| TUB-040 - Dose escalation | DRUG | TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle. |
| TUB-040 - RP2D | DRUG | TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle. Dose based on the RP2D |
| TUB-040 + Carbo + BEV | DRUG | Ph1b: A complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered along with carboplatin (Carbo) and bevacizumab (BEV) as an intravenous (IV) solution on day 1 of each treatment cycle for up to 6 cycles. |
Key Inclusion Criteria: 1. Adults, male or nonpregnant, nonbreastfeeding female, age ≥18 years at the date of consent. 2. Eastern Cooperative Oncology Group performance status of 0 or 1. 3. Documented radiographic progression on or after the most recent line of anticancer therapy. 4. Life expectanc...
TUB-040 is an investigational small molecule developed by Gilead Sciences, Inc. (ticker GILD) for the treatment of solid tumors. It is being studied in non-small cell lung cancer, ovarian cancer, and uterine endometrial cancer. TUB-040 is in Phase 2 clinical development and has not been approved by the FDA.
TUB-040 targets NaPi2b, a protein expressed on the surface of certain tumor cells. By binding NaPi2b, TUB-040 is designed to deliver its therapeutic payload selectively to cancer cells. NaPi2b is the molecular target of interest across the tumor types being studied, including non-small cell lung cancer and ovarian cancer.
TUB-040 is being developed by Gilead Sciences, Inc., which trades under the ticker GILD. Gilead is the sponsor of the clinical program evaluating TUB-040 in non-small cell lung cancer, ovarian cancer, and uterine endometrial cancer. The drug remains investigational and has not received FDA approval.
TUB-040 is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The program includes both Phase 1 and Phase 2 studies across non-small cell lung cancer, ovarian cancer, and uterine endometrial cancer, with two active trials and no completed trials.
TUB-040 is being evaluated in four registered studies. NCT06303505 is a first-in-human Phase 1 trial in ovarian cancer and non-small cell lung cancer. NCT07736937 is a Phase 1 trial combining TUB-040 with standard ovarian cancer drugs. NCT07806773 is a Phase 2 trial in nonsquamous NSCLC, and NCT07743541 is a Phase 1 trial in uterine endometrial cancer.