A Study of Sigvotatug Vedotin in Advanced Solid Tumors

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.

Conditions

• Carcinoma, 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

Interventions

DRUG

sigvotatug vedotin

Administered into the vein (IV; intravenously)

DRUG

pembrolizumab

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

DRUG

cisplatin

75 mg/m2 every 3 weeks, given by IV

DRUG

carboplatin

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

Sponsors & Collaborators

• Seagen, a wholly owned subsidiary of Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-08

Primary Completion

2027-06-16

Completion

2029-03-22

FDA Drug

Yes

Countries

• United States
• France
• South Korea
• Spain
• Switzerland
• Taiwan
• United Kingdom

Study Locations