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An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-399 in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-399 | Experimental | ABBV-399 via intravenous administration at escalating dose levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-399 | Drug | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) | 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. | Up to 24 months |
| Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399 | 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. | Up to 21 days |
| Terminal elimination half life (t1/2) | Terminal elimination half life (t1/2) | Up to 24 months |
| Maximum Observed Concentration (Cmax) | Maximum observed concentration (Cmax) | Up to 24 months |
| Time to Cmax (Tmax) | Time to Cmax (Tmax) | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Time | PFS time is defined as the time from the participant's first dose of ABBV-399 to either the participant's disease progression or death, whichever occurs first. | Up to 24 months |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shizuoka Cancer Center /ID# 166940 | Sunto-gun | Shizuoka | 411-8777 | Japan | ||
| National Cancer Center Hospital /ID# 166939 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33675179 | Derived | Fujiwara Y, Kenmotsu H, Yamamoto N, Shimizu T, Yonemori K, Ocampo C, Parikh A, Okubo S, Fukasawa K, Murakami H. Phase 1 study of telisotuzumab vedotin in Japanese patients with advanced solid tumors. Cancer Med. 2021 Apr;10(7):2350-2358. doi: 10.1002/cam4.3815. Epub 2021 Mar 6. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000626235 | telisotuzumab vedotin |
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Objective response rate (ORR) is defined as the proportion of participants with a confirmed partial or complete response to the treatment. Evaluation of tumor response is based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
| Up to 24 months |
| Duration of response (DOR) | DOR is defined as the time from the participant's initial objective response to study drug therapy to disease progression or death, whichever occurs first. | Up to 24 months |
| Chuo-ku |
| Tokyo |
| 104-0045 |
| Japan |