Study of Sigvotatug Vedotin for Advanced Solid Tumors
This study is testing a drug called sigvotatug vedotin, alone or combined with pembrolizumab, and possibly with chemotherapy drugs like cisplatin or carboplatin. It aims to find out if sigvotatug vedotin is safe and if it works to treat certain advanced solid tumors, including non-small cell lung cancer, head and neck squamous cell cancer, HER2-negative breast cancer, and esophageal cancers. The study will look at side effects and how well the drug treats the cancer. You may be eligible if you have one of these confirmed advanced solid tumors and are at least 18 years old. The main goals are to understand the side effects and safety of the treatments.
- Study design
- This study is designed to enroll 1006 participants. It will have four parts to determine the best dose, safety, and effectiveness of sigvotatug vedotin.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for adverse events and laboratory abnormalities for up to 3 years after your last dose of sigvotatug vedotin, or up to 90 days after your last dose of pembrolizumab if you receive it.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04389632
A Study of Sigvotatug Vedotin in Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentSeagen, a wholly owned subsidiary of Pfizer
~1,006 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:sigvotatug vedotinpembrolizumabcisplatincarboplatin
At a glance
Recruiting sites
145 of 158 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs)
Measured over 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
+2 more outcomes measured
Conditions
Where it's being run
158 sites across 37 statesIllinois16
Spain16
Washington12
California10
New York10
Kansas9
Texas9
Florida7
Study leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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).
Non-small cell lung cancer (NSCLC)
Head and neck squamous cell cancer (HNSCC)
Advanced HER2-negative breast cancer
Esophageal squamous cell carcinoma (ESCC)
Esophageal/Gastro-esophageal junction adenocarcinoma (EAC/GEJ)
Cutaneous squamous cell cancer (cSCC)
Exocrine pancreatic adenocarcinoma
Bladder cancer
Cervical cancer
Gastric cancer
High grade serous ovarian cancer (HGSOC)
Part A only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic options.
Part B only: Participants must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies. Participants must have received platinum-based therapy and a PD-1/PD-(L)1 inhibitor, if applicable and available.
Part C only: For pembrolizumab combination cohorts, participants must be eligible for pembrolizumab per local standard of care. For pembrolizumab with cisplatin or carboplatin, participants must be eligible for both pembrolizumab and the platinum agent per local standard of care. Participants must be treatment naïve for locally advanced or metastatic systemic therapy (prior definitively intended or \[neo\]adjuvant therapy is allowed).
Part D only: Participants must be treatment naïve for locally advanced or metastatic systemic therapy.
Participants enrolled in the following study parts should have a tumor site accessible for biopsy and agree to biopsy as follows:
Disease-specific expansion cohorts (Part B and Part D): A baseline fresh tumor biopsy is required. An archival biopsy collected within 90 days prior to first dose of study drug may be used.
Biology expansion cohort: pretreatment biopsy and on-treatment (Cycle 1) biopsy
An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Measurable disease per the RECIST v1.1 at baseline
Exclusion
History of another malignancy within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:
are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment,
have no new or enlarging brain metastases, and
are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to first dose of study drug.
In Part D, participants with untreated, asymptomatic CNS metastases smaller than 1 cm may be enrolled without definitive treatment as long as they have no neurological symptoms, no or minimal surrounding edema, and no requirements for corticosteroids.
Carcinomatous meningitis
Previous receipt of an MMAE-containing agent or an agent targeting integrin beta-6
Pre-existing neuropathy Grade 1 or greater per the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) for Parts C and D cohorts with cisplatin or carboplatin; Grade 2 or greater per the NCI CTCAE v5.0 for all other cohorts
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.
Routine antimicrobial prophylaxis is permitted
Grade ≥3 pulmonary disease unrelated to underlying malignancy. This includes clinically severe pulmonary function compromise resulting from clinically significant pulmonary illnesses
Part C and D: Prior therapy with a PD-1 inhibitor, anti-PD-(L)1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a Grade 3 or higher immune-mediated adverse event (IMAE).
History of noninfectious interstitial lung disease (ILD) or pneumonitis that required steroids, current ILD or pneumonitis, or suspected ILD or pneumonitis that cannot be ruled out by imaging at screening
Known diffusing capacity of the lung for carbon monoxide (DLCO; adjusted for hemoglobin) \<50% predicted
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
What this trial measures
- Number of participants with adverse events (AEs)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
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.
- Number of patients with laboratory abnormalitiesThrough 30-37 days following last dose of sigvotatug vedotin; up to 3 years
- Number of participants with dose-limiting toxicities (DLTs)Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years