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Testing a new drug for advanced solid tumors

A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors

Phase 1 Interventional Seagen Inc. · NCT04389632

This study is testing a new drug called sigvotatug vedotin to see if it can safely help people with advanced solid tumors, both on its own and with other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment1006 (estimated)
Ages18 Years and up
SexAll
SponsorSeagen Inc. Industry-sponsored
Drugs / interventionspembrolizumab, chemotherapy
Locations159 sites (Anchorage, Alaska and 158 other locations)
Trial IDNCT04389632 on ClinicalTrials.gov

What this trial studies

This trial investigates the drug sigvotatug vedotin (SGN-B6A) in patients with advanced solid tumors, assessing its safety and effectiveness. The study is divided into four parts: determining the optimal dosage, evaluating safety and efficacy alone and in combination with pembrolizumab and chemotherapy, and examining its effects in treatment-naive patients. Participants will be monitored for side effects and overall response to treatment. The trial aims to provide insights into the potential of this drug for various types of solid tumors.

Who should consider this trial

Good fit: Ideal candidates include individuals with metastatic or unresectable solid tumors such as NSCLC, HNSCC, and HER2-negative breast cancer.

Not a fit: Patients with early-stage tumors or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar drug combinations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria

* 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.

Where this trial is running

Anchorage, Alaska and 158 other locations

+109 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Non-Small Cell LungSquamous Cell Carcinoma of Head and NeckHER2 Negative Breast NeoplasmsEsophageal Squamous Cell CarcinomaEsophageal AdenocarcinomaGastroesophageal Junction AdenocarcinomaOvarian NeoplasmsCutaneous Squamous Cell Cancer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.