A Phase 1 interventional study of sigvotatug vedotin and pembrolizumab in Carcinoma, Non-Small Cell Lung, Squamous Cell Carcinoma of Head and Neck and HER2 Negative Breast Neoplasms, sponsored by Seagen, a wholly owned subsidiary of Pfizer. Recruiting at 158 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Seagen, a wholly owned subsidiary of Pfizer · Phase 1, Interventional, and Treatment
This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.
The study will have four parts.
In Parts C and D, participants will receive sigvotatug vedotin with either:
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 1,006 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Seagen, a wholly owned subsidiary of Pfizer is the lead sponsor of 30 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 3 (27%) have results posted.
Counted across the registry records on this site, refreshed daily.
Disease indication
Participants must have histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below (dependent on study part).
Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:
Exclusion Criteria
Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:
Any uncontrolled Grade 3 or higher (per NCI CTCAE v5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of sigvotatug vedotin.
sigvotatug vedotin monotherapy
Drug: sigvotatug vedotin
sigvotatug vedotin monotherapy
Drug: sigvotatug vedotin
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Drug: sigvotatug vedotin · Drug: pembrolizumab · Drug: cisplatin · Drug: carboplatin
sigvotatug vedotin + pembrolizumab +/- (carboplatin)
Drug: sigvotatug vedotin · Drug: pembrolizumab · Drug: carboplatin
sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)
Drug: sigvotatug vedotin · Drug: pembrolizumab · Drug: cisplatin · Drug: carboplatin
Administered into the vein (IV; intravenously)
Also known as: SGN-B6A, PF-08046047
200mg every 3 weeks or 400mg every 6 weeks, given by IV
Also known as: Keytruda
75 mg/m2 every 3 weeks, given by IV
AUC 5 mg/mL per min every 3 weeks, given by IV
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Time frame: Through 30-37 days following last dose of sigvotatug vedotin. For participants receiving pembrolizumab up to 90 days after last dose of pembrolizumab; up to 3 years
Number of patients with laboratory abnormalities
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator assessment
The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to RECIST v1.1.
Time frame: Up to approximately 3 years
Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause
Time frame: Up to approximately 3 years
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
The time from the start of any study treatment to the first documentation of PD, or death due to any cause
Time frame: Up to approximately 3 years
Overall survival (OS)
The time from the start of any study treatment to the date of death due to any cause
Time frame: Up to approximately 3 years
Area under the concentration-time curve (AUC)
Pharmacokinetic (PK) endpoint
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Concentration at the end of infusion (Ceoi)
PK endpoint
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Maximum observed concentration (Cmax)
PK endpoint
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Time to maximum observed concentration (Tmax)
PK endpoint
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Trough concentration (Ctrough)
PK endpoint
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Apparent terminal elimination half-life (t1/2)
PK endpoint
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Number of participants with antidrug antibodies (ADAs)
Time frame: Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Showing the first 100 of 158 sites across 7 countries.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Carcinoma, Non-Small-Cell Lung→
Seagen, a wholly owned subsidiary of Pfizer