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Also known as SGN-B6A, PF-08046047
sigvotatug vedotin · 4 trials · 16 indications
Overall survival defined as the duration from enrollment to death.
Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by blinded independent central review (BICR) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.
The time from date of randomization to date of death due to any cause.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
| Arm | Type | Description |
|---|---|---|
| Sigvotatug Vedotin with Pembrolizumab | EXPERIMENTAL | Participants will receive Sigvotatug Vedotin, administered as an IV infusion and pembrolizumab, administered as an IV infusion. |
| Pembrolizumab Monotherapy | ACTIVE_COMPARATOR | Participants will receive pembrolizumab, administered as an IV infusion. |
| Experimental Arm | EXPERIMENTAL | sigvotatug vedotin monotherapy |
| Control Arm | ACTIVE_COMPARATOR | Docetaxel monotherapy |
| sigvotatug vedotin | EXPERIMENTAL | sigvotatug vedotin monotherapy 1.8 mg/kg adjusted ideal body weight intravenous administration on Days 1 and 15 of a 28-day cycle. |
| Part A: Dose escalation | EXPERIMENTAL | sigvotatug vedotin monotherapy |
| Part B: Dose expansion | EXPERIMENTAL | sigvotatug vedotin monotherapy |
| Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC | EXPERIMENTAL | sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin) |
| Part D: sigvotatug vedotin combination therapy in 1L NSCLC | EXPERIMENTAL | sigvotatug vedotin + pembrolizumab +/- (carboplatin) |
| Part D: sigvotatug vedotin combination therapy in 1L HNSCC | EXPERIMENTAL | sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin) |
| Name | Type | Description |
|---|---|---|
| Sigvotatug Vedotin | DRUG | MMAE-Antibody Drug Conjugate targeting Integrin Beta-6 |
| Pembrolizumab | DRUG | Anti-PD-(L)1 |
| docetaxel | DRUG | 75 mg/m\^2 given into the vein (IV; intravenously) on Day 1 of a 21-day cycle |
| cisplatin | DRUG | 75 mg/m2 every 3 weeks, given by IV |
| carboplatin | DRUG | AUC 5 mg/mL per min every 3 weeks, given by IV |
Inclusion Criteria: 1. Participants must meet the following criteria: 1. Have pathologically confirmed Stage IIIB or IIIC NSCLC and not be a candidate for surgical resection or definitive chemoradiation, or Stage IV NSCLC per the AJCC Staging Manual (Version 8.0) and the UICC Staging System (Ei...
Sigvotatug vedotin is an investigational antibody-drug conjugate being studied for non-small cell lung cancer and other advanced solid tumors. Its lead program targets previously treated NSCLC, and it is also being evaluated in combination with pembrolizumab in patients with high PD-L1 levels. It is not approved for any indication.
Sigvotatug vedotin targets integrin beta-6, or ITGB6, an integrin protein expressed on certain tumor cells. The antibody-drug conjugate binds ITGB6 and delivers a cytotoxic payload into target cells. ITGB6 is the molecular target of the agent, and it is classified as an inhibitor.
Sigvotatug vedotin is being developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is running the clinical development program for the asset across non-small cell lung cancer and other solid tumor indications.
Sigvotatug vedotin is in Phase 3 clinical development. The program includes two Phase 3 trials in non-small cell lung cancer and earlier-phase studies in advanced solid tumors. It is investigational and has not been approved by the FDA for any indication.
Sigvotatug vedotin is being studied in several trials, including NCT06012435, a Phase 3 study versus docetaxel in previously treated non-small cell lung cancer, and NCT06758401, a Phase 3 study combining it with pembrolizumab in NSCLC with high PD-L1. Earlier studies include NCT04389632 and NCT06549816.
Yes, sigvotatug vedotin is also known as SGN-B6A. The two names refer to the same antibody-drug conjugate developed by Pfizer. Trials such as NCT06549816 and NCT06012435 use the SGN-B6A designation, while other studies use sigvotatug vedotin.