Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-806 · 4 trials · 2 indications
Time from enrollment to death from any cause.
Evaluation of vitals signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (at final visit)
Assay for ABT-806
Tumor receptor occupancy (Cohort 1 and Cohort 2)
Biodistribution and dosimetry (Cohort 1 and Cohort 2)
Evaluation of vital signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (periodic)
Assay for ABT-806
Assay for ABT-806
| Arm | Type | Description |
|---|---|---|
| ITT-PTS: Personalized Treatment Strategy (Immuno-oncology) | EXPERIMENTAL | For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows: Immuno-oncology included PD-L1 IHC combined positivity score \>10, high microsatellite instability, tumor mutation burden \>15 mutations per megabase, and/or Epstein-Barr virus positive. These patients received standard cytotherapy plus Nivolumab. |
| ITT-PTS: Personalized Treatment Strategy (HER2 amplified) | EXPERIMENTAL | HER2 amplified. These patients received standard cytotherapy plus Trastuzumab. |
| ITT-PTS: Personalized Treatment Strategy (EFGR amplified) | EXPERIMENTAL | EGFR amplified. These patients received ABT-806. |
| ITT-PTS: Personalized Treatment Strategy (FGFR2 amplified) | EXPERIMENTAL | FGFR2 amplified. These patients received standard cytotherapy plus Bemarituzumab. |
| ITT-PTS: Personalized Treatment Strategy (MAPK/PIK3CA aberrant) | EXPERIMENTAL | MAPK/PIK3CA aberrant. These patients received standard cytotherapy plus Ramucirumab. |
| ITT-PTS: Personalized Treatment Strategy (EGFR expressing) | EXPERIMENTAL | EGFR expressing. These patients received standard cytotherapy plus ABT 806. |
| ITT-PTS: Personalized Treatment Strategy (All negative) | EXPERIMENTAL | All negative. These patients received standard cytotherapy plus Ramucirumab. |
| Non-ITT: Standard Therapy | OTHER | Patients without monoclonal antibodies available received standard cytotherapy. |
| ABT-806 Arm | EXPERIMENTAL | - |
| ABT-806i Arm | EXPERIMENTAL | Subjects with advanced solid tumors |
| Name | Type | Description |
|---|---|---|
| Trastuzumab | DRUG | Trastuzumab |
| ABT-806 | DRUG | ABT-806 |
| Bemarituzumab | DRUG | Bemarituzumab |
| Ramucirumab | DRUG | Ramucirumab |
| Nivolumab | DRUG | Nivolumab |
| Standard cytotherapy | DRUG | FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line) |
| ABT-806i | DRUG | ABT-806i will be administered by intravenous infusion. |
Inclusion Criteria: 1. Histologically confirmed metastatic gastric or esophagogastric junction (type I,II,III Siewert) adenocarcinoma 2. Newly-diagnosed chemo-naïve or recurrent after curative-intent surgery * \>6 months after completion of adjuvant therapy (including chemotherapy and/or radiot...
ABT-806 is an investigational small molecule being studied for use in advanced solid tumors and adenocarcinoma. It is being developed by AbbVie Inc. (NYSE: ABBV) and is currently in Phase 2 clinical development for oncology indications.
ABT-806 is a small molecule being developed for oncology. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied in biomarker-selected patient populations with advanced solid tumors.
ABT-806 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical trials of ABT-806 in patients with advanced solid tumors and adenocarcinoma.
ABT-806 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has completed three Phase 1 trials and is being evaluated in a Phase 2 study for adenocarcinoma.
ABT-806 has been studied in several clinical trials, including NCT01255657, a Phase 1 study in advanced solid tumors with 49 participants; NCT01406119, an extension study with 14 participants; and NCT01472003, a biodistribution study with 18 participants. A Phase 2 trial, NCT02213289, evaluated ABT-806 in adenocarcinoma.
ABT-806 and ABT-806i are related but distinct. ABT-806i is a radiolabeled form of ABT-806, specifically 111In-ABT-806, used in a clinical trial (NCT01472003) to evaluate biodistribution and imaging characteristics in patients with advanced solid tumors.