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Also known as PF-07275315 dose 1, PF-07275315
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...
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PF-07275315 is an investigational small molecule being studied for moderate to severe atopic dermatitis, moderate to severe chronic obstructive pulmonary disease, and non-small cell lung cancer. It is also being evaluated in healthy volunteers. The drug is in Phase 2 clinical development and is not approved by the FDA.
PF-07275315 targets the cytokines IL-4, IL-13, and TSLP. These are signaling proteins involved in inflammatory and immune responses. By targeting these cytokines, the drug is being studied for its potential effects in conditions like atopic dermatitis and chronic obstructive pulmonary disease.
PF-07275315 is being developed by Pfizer, Inc., which trades under the ticker symbol PFE on the New York Stock Exchange. The company is conducting clinical trials to evaluate the drug's safety and efficacy in several indications.
PF-07275315 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials are ongoing to assess its safety and effectiveness in treating atopic dermatitis and chronic obstructive pulmonary disease.
PF-07275315 is being studied in several clinical trials. NCT05995964 is a Phase 2 trial in moderate to severe atopic dermatitis. NCT07363694 is a Phase 2 trial in moderate to severe COPD. NCT06675188, a Phase 1 trial in healthy Chinese participants, has been completed.
Yes, PF-07275315 is also known as sigvotatug vedotin. The drug is referred to by both names in clinical research. It is being developed by Pfizer for multiple indications, including non-small cell lung cancer, where it is being studied under the name sigvotatug vedotin.