Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Telisotuzumab vedotin
ABBV-399 · 5 trials · 4 indications
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) per BICR or death from any cause.
OS is defined as the time from randomization to the event of death from any cause.
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication (any-grade and Grade \>= 2).
Peripheral neuropathy is defined by peripheral neuropathy SMQ (narrow) (any-grade and Grade \>= 2)
Treatment-emergent ocular surface disorders defined by corneal epitheliopathy company MedDRA query (CMQ) (any-grade and Grade \>= 2).
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
OR will be defined as achieving confirmed complete response (CR) or confirmed partial response (PR) based on response evaluation criteria in solid tumors (RECIST), version 1.1.
ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
AUC (0-t) is defined as area under the concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.
MTD/MAD is defined as the highest dose level at which less than 2 of 6 (or \< 33% if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
Maximum observed concentration (Cmax)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
The RPTD of ABBV-399 when administered as monotherapy and in combination with osimertinib, erlotinib or nivolumab will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data.
Maximum observed plasma concentration (Cmax).
Terminal elimination half life.
| Arm | Type | Description |
|---|---|---|
| Telisotuzumab Vedotin | EXPERIMENTAL | Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria. |
| Docetaxel | ACTIVE_COMPARATOR | Participants will receive docetaxel every 3 weeks until meeting study drug discontinuation criteria. |
| Telisotuzumab Vedotin Dose A | EXPERIMENTAL | Participants will receive telisotuzumab vedotin dose A, as part of the 3 year study duration. |
| Telisotuzumab Vedotin Dose B | EXPERIMENTAL | Participants will receive telisotuzumab vedotin dose B, as part of the 3 year study duration. |
| Telisotuzumab Vedotin Dose C | EXPERIMENTAL | Participants will receive telisotuzumab vedotin dose C, as part of the 3 year study duration. |
| ABBV-399 | EXPERIMENTAL | ABBV-399 via intravenous administration at escalating dose levels. |
| Monotherapy Telisotuzumab vedotin (21-day dosing cycles) | EXPERIMENTAL | Telisotuzumab vedotin will be administered at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate Telisotuzumab vedotin. |
| Monotherapy Telisotuzumab vedotin(28-day dosing cycles) | EXPERIMENTAL | Telisotuzumab vedotin will be administered at escalating dose levels in 28-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate Telisotuzumab vedotin. |
| Monotherapy Expansion Cohort | EXPERIMENTAL | Telisotuzumab vedotin will be administered every 14 days on a 28-day dosing cycle. |
| Arm A (Telisotuzumab vedotin plus Erlotinib) | EXPERIMENTAL | Telisotuzumab vedotin to be evaluated with Erlotinib. |
| Arm D (Telisotuzumab vedotin plus Nivolumab) | EXPERIMENTAL | Telisotuzumab vedotin to be evaluated with Nivolumab. |
| Arm E (Telisotuzumab vedotin plus Osimertinib) | EXPERIMENTAL | Telisotuzumab vedotin to be evaluated with Osimertinib. |
| Name | Type | Description |
|---|---|---|
| Telisotuzumab Vedotin | BIOLOGICAL | Intravenous (IV) Infusion |
| Docetaxel | DRUG | IV Infusion |
| ABBV-399 | DRUG | Intravenous infusion |
| Osimertinib | DRUG | It is administered orally everyday. |
| Nivolumab | DRUG | It is an intravenous infusion administered every 14 days. |
| Erlotinib | DRUG | It is administered orally everyday. |
Inclusion Criteria: * Projected life expectancy of at least 12 weeks. * Participants must have c-Met overexpressing non-small cell lung cancer (NSCLC) as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory using the VENTANA MET (SP44) RxDx assay. * Archival or fresh tumor materia...
ABBV-399 is an investigational small molecule being studied for the treatment of advanced solid tumors cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety and pharmacokinetics in patients with advanced solid tumors.
ABBV-399 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with advanced solid tumors.
ABBV-399 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for advanced solid tumors cancer.
ABBV-399 has one completed Phase 1 clinical trial, identified as NCT03311477. This study evaluated the safety and pharmacokinetics of ABBV-399 in Japanese participants with solid tumors. The trial enrolled 9 participants and was conducted in Japan.
ABBV-399 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for advanced solid tumors cancer. The drug has completed a Phase 1 trial, but it remains under investigation and has not received regulatory approval.