Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BG-92505 · 1 trial · 1 indication
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment, whether considered related to study treatment or not. A serious adverse event is any untoward medical occurrence that, at any dose, meets one or more of the criteria listed in the view of either the investigator or the Sponsor: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent or significant disability/incapacity 5. Is a congenital anomaly/birth defect
| Arm | Type | Description |
|---|---|---|
| Part A1: Monotherapy dose escalation | EXPERIMENTAL | Ascending dose levels of BG-92505 will be evaluated as monotherapy in participants with selected advanced solid tumors. |
| Part A2: Monotherapy safety expansion | EXPERIMENTAL | Selected dose levels of BG-92505 that have been determined to be safe in Monotherapy Dose Escalation, will be evaluated in participants with selected advanced solid tumors. |
| Part B: Combination Dose Escalation (BG-92505 + Anti-cancer agent) | EXPERIMENTAL | Ascending dose levels of BG-92505 in combination with anti-cancer agent will be evaluated in participants with selected advanced solid tumors. |
| Name | Type | Description |
|---|---|---|
| BG-92505 | DRUG | Administered orally. |
| Anti-Cancer Agent | DRUG | Administered by intravenous infusion. |
Inclusion Criteria: Participants are eligible to be included in the study only if they meet all the following criteria: 1. (i) Part A1 (Mono Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable non-small cell lung cancer (NSCLC), esop...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |