CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 1,006 target
Drug / intervention
sigvotatug vedotin +3 moredrug
Likely dose
pembrolizumab 200mgfrom record
Key inclusion· 8
  • ✓Histologically or cytologically confirmed metastatic or unresectable solid malignancy
  • ✓ECOG Performance Status 0 or 1
  • ✓Measurable disease per RECIST v1.1 at baseline
  • ✓Part A: disease relapsed/refractory or intolerant to SOC with no appropriate options
Key exclusion· 8
  • ✕History of another malignancy within 3 years or residual disease, except negligible-risk malignancies
  • ✕Known active CNS metastases
  • ✕Carcinomatous meningitis
  • ✕Prior receipt of MMAE-containing agent or integrin beta-6 targeting agent

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

In the news

4 articles

Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.

Search/NCT04389632
NCT04389632Phase 1RecruitingHigh Momentum
Long Recruiting
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A Phase 1 Study of Sigvotatug Vedotin in Advanced Solid Tumors

Seagen, a wholly owned subsidiary of Pfizer·interventional·Posted May 15, 2020·Updated May 11, 2026

In Brief

A Phase 1 clinical trial evaluating sigvotatug vedotin, pembrolizumab, and 2 other interventions for Carcinoma, Non-Small Cell Lung and 11 related conditions. Currently recruiting, targeting 1,006 participants across 159 sites in 7 countries.

Signals

Enrolling ahead of pace

Detailed Summary

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. * Part A of the study will find out how much sigvotatug vedotin should be given to participants. * Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors. * Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs. * Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors. * In Parts C and D, participants will receive sigvotatug vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small Cell Lung, Squamous Cell Carcinoma of Head and Neck, HER2 Negative Breast Neoplasms, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Ovarian Neoplasms, Cutaneous Squamous Cell Cancer, Exocrine Pancreatic Adenocarcinoma, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Stomach Neoplasms
CountriesFrance, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 1Recruiting
202120222023202420252026202720282029
First PostedMay 15, 2020
Enrollment StartJun 8, 2020
Primary CompletionJun 16, 2027
Study CompletionMar 22, 2029
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 6.1 years agoPrimary completion in 11 months

Interventions

sigvotatug vedotindrug

Administered into the vein (IV; intravenously)

pembrolizumabdrug

200mg every 3 weeks or 400mg every 6 weeks, given by IV

cisplatindrug

75 mg/m2 every 3 weeks, given by IV

carboplatindrug

AUC 5 mg/mL per min every 3 weeks, given by IV