Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cabiralizumab · 2 trials · 2 indications
PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The number of participants that experienced an AE during the course of the study while participating in cabiralizumab monotherapy treatment.
The number of participants that experienced a SAE during the course of the study while participating in cabiralizumab monotherapy treatment.
The number of participants that experienced an AE meeting protocol-defined DLT criteria during the course of the study while participating in cabiralizumab monotherapy treatment.
The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab monotherapy treatment.
The number of participants that died during the course of the study while participating in cabiralizumab monotherapy treatment.
The number of participants that experienced a laboratory abnormality during the course of the study while participating in cabiralizumab monotherapy treatment.
| Arm | Type | Description |
|---|---|---|
| Arm A | ACTIVE_COMPARATOR | Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE) |
| Arm B | EXPERIMENTAL | Cabiralizumab Q2W + Nivolumab Q4W |
| Arm C | EXPERIMENTAL | Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W |
| Arm D | EXPERIMENTAL | Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W |
| Monotherapy | EXPERIMENTAL | Cabiralizumab administered as a single agent intravenous formulation |
| Combination Therapy | EXPERIMENTAL | Cabiralizumab will be administered in combination with Nivolumab as an intravenous formulation |
| Name | Type | Description |
|---|---|---|
| Cabiralizumab | BIOLOGICAL | specified dose on specified days |
| Nab-paclitaxel | DRUG | specified does on specified days |
| Onivyde | DRUG | specified dose on specified days |
| Nivolumab | BIOLOGICAL | specified dose on specified days |
| Fluorouracil | DRUG | specified dose on specified days |
| Gemcitabine | DRUG | specified dose on specified days |
| Oxaliplatin | DRUG | specified dose on specified day |
| Leucovorin | DRUG | Specified dose on specified days |
| Irinotecan Hydrochloride | DRUG | Specified dose on specified days |
Inclusion Criteria: * Must have histological or cytological confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, which has progressed on or after one line of chemotherapy * ECOG Performance status 0-1 * Adequate organ functions * Measurable disease Exclusion Criter...
Top 20 of 69 competitors
Cabiralizumab is an investigational monoclonal antibody being studied for advanced malignancies and advanced pancreatic cancer. It is being developed by Bristol-Myers Squibb Company (BMY) as a potential cancer treatment. The drug is currently in clinical development and is not approved by the FDA.
Cabiralizumab targets CSF1R, which stands for colony-stimulating factor 1 receptor. It acts as an antagonist of this target. By blocking CSF1R, the drug may affect tumor-associated macrophages, which are cells in the tumor microenvironment that can support cancer growth.
Cabiralizumab is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced cancers, including pancreatic cancer.
Cabiralizumab is in Phase 1 and Phase 2 clinical trials. One Phase 1 trial has been completed, and one Phase 2 trial has also been completed. The drug is still investigational and has not received FDA approval for any indication.
Cabiralizumab has been studied in two completed trials. NCT03158272 was a Phase 1 study of cabiralizumab alone or with nivolumab in advanced cancer, enrolling 19 patients in Japan. NCT03336216 was a Phase 2 study of cabiralizumab with nivolumab with or without chemotherapy in advanced pancreatic cancer, enrolling 205 patients across multiple countries.
Cabiralizumab is not known by any other names. It is a distinct monoclonal antibody targeting CSF1R. In clinical trials, it has been studied in combination with nivolumab, which is a separate PD-1 inhibitor, but cabiralizumab itself is a unique investigational agent.