A Study Of SGN-B6A In Advanced Solid Tumors

Study Overview

A Study of SGN-B6A in Advanced Solid Tumors

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.

N/A

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

DRUG: sigvotatug vedotin
DRUG: pembrolizumab
DRUG: cisplatin
DRUG: carboplatin

SGNB6A-001
C5751001 (OTHER Identifier) (OTHER: Alias Study Number)
2023-508469-34-00 (REGISTRY Identifier) (REGISTRY: CTIS (EU))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-05-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-12
First Submitted that Met QC Criteria 2020-05-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-13
First Posted (ACTUAL) 2020-05-15	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part A: Dose escalation sigvotatug vedotin monotherapy	DRUG: sigvotatug vedotin Administered into the vein (IV; intravenously)
EXPERIMENTAL: Part B: Dose expansion sigvotatug vedotin monotherapy	DRUG: sigvotatug vedotin Administered into the vein (IV; intravenously)
EXPERIMENTAL: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCC sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)	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
EXPERIMENTAL: Part D: sigvotatug vedotin combination therapy in 1L NSCLC sigvotatug vedotin + pembrolizumab +/- (carboplatin)	DRUG: sigvotatug vedotin Administered into the vein (IV; intravenously) DRUG: pembrolizumab 200mg every 3 weeks or 400mg every 6 weeks, given by IV DRUG: carboplatin AUC 5 mg/mL per min every 3 weeks, given by IV
EXPERIMENTAL: Part D: sigvotatug vedotin combination therapy in 1L HNSCC sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)	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

Primary Outcome Measures	Measure Description	Time Frame
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.	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		Through 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

Secondary Outcome Measures	Measure Description	Time Frame
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.	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	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	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	Up to approximately 3 years
Area under the concentration-time curve (AUC)	Pharmacokinetic (PK) endpoint	Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Concentration at the end of infusion (Ceoi)	PK endpoint	Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Maximum observed concentration (Cmax)	PK endpoint	Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Time to maximum observed concentration (Tmax)	PK endpoint	Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Trough concentration (Ctrough)	PK endpoint	Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Apparent terminal elimination half-life (t1/2)	PK endpoint	Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
Number of participants with antidrug antibodies (ADAs)		Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Seagen Pfizer CT.gov Call Center

Phone Number: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Pfizer CT.gov Call Center, Pfizer

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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