Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JAB-3312 · 1 trial · 2 indications
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (Dose escalation phase)
ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose expansion phase)
DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose expansion phase)
DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose expansion phase)
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first. (Dose expansion phase)
OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor. (Dose expansion phase)
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (Dose escalation phase)
| Arm | Type | Description |
|---|---|---|
| JAB-3312+Pembrolizumab dose escalation | EXPERIMENTAL | Dose escalation |
| JAB-3312+ Binimetinib dose escalation | EXPERIMENTAL | Dose escalation |
| JAB-3312+Pembrolizumab dose expansion | EXPERIMENTAL | Dose expansion |
| JAB-3312+Binimetinib dose expansion | EXPERIMENTAL | Dose expansion |
| JAB-3312+Sotorasib dose escalation | EXPERIMENTAL | Dose escalation |
| JAB-3312+ Osimertinib dose escalation | EXPERIMENTAL | Dose escalation |
| JAB-3312+ Sotorasib dose expansion | EXPERIMENTAL | Dose expansion |
| JAB-3312+ Osimertinib dose expansion | EXPERIMENTAL | Dose expansion |
| Name | Type | Description |
|---|---|---|
| JAB-3312 | DRUG | JAB-3312 will be administered orally, variable dose. |
| Binimetinib | DRUG | Binimetinib will be administered orally. |
| Pembrolizumab | DRUG | Pembrolizumab will be administered as an intravenous infusion. |
| Sotorasib | DRUG | Sotorasib will be administered orally. |
| Osimertinib | DRUG | Osimertinib will be administered orally. |
Inclusion Criteria: * Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor. Some cohorts must meet specific expression or gene mutation where indicated * Sufficient organ function * Participants must have at least 1 measurable lesion as defined by RECIST v1...
| 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 |
JAB-3312 is an investigational small molecule developed by AbbVie Inc. (ticker ABBV) for the treatment of advanced solid tumors. It is being studied as part of combination therapy in adult patients with solid tumors, including non-small cell lung cancer (NSCLC). It remains in clinical development and is not an approved therapy.
JAB-3312 is being evaluated for use in adult patients with advanced solid tumors, including non-small cell lung cancer (NSCLC). It is studied as a combination therapy rather than as a single agent. The program is investigational, and JAB-3312 has not been approved for any indication.
JAB-3312 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating JAB-3312 in advanced solid tumors.
JAB-3312 is in Phase 1 clinical development. The single registered trial of JAB-3312 has completed, and no active trials are currently listed. JAB-3312 is investigational and has not been approved by the FDA for any indication.
JAB-3312 has been studied in one Phase 1 trial, NCT04720976, titled "JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors." The trial enrolled 58 adults aged 18 years and older in the United States and has completed. It evaluated JAB-3312 in solid tumors including NSCLC.
The Phase 1 trial of JAB-3312, NCT04720976, was not randomized and was not double blinded. It used a controlled design and enrolled 58 adult patients with advanced solid tumors, including NSCLC, at sites in the United States. The study has completed.