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A Study of Sigvotatug Vedotin in Advanced Solid Tumors

ConditionsCarcinoma, Non-Small Cell LungSquamous Cell Carcinoma of Head and NeckHER2 Negative Breast NeoplasmsEsophageal Squamous Cell CarcinomaEsophageal AdenocarcinomaGastroesophageal Junction AdenocarcinomaOvarian NeoplasmsCutaneous Squamous Cell CancerExocrine Pancreatic AdenocarcinomaUrinary Bladder NeoplasmsUterine Cervical NeoplasmsStomach Neoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeagen, a wholly owned subsidiary of Pfizer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • sigvotatug vedotin

    Drug

    Administered into the vein (IV; intravenously)

  • pembrolizumab

    Drug

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

  • cisplatin

    Drug

    75 mg/m2 every 3 weeks, given by IV

  • carboplatin

    Drug

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

Treatment groups

1,006 Participants
are divided into 5 treatment groups
Group A: Part A: Dose escalationExperimental treatment 1 intervention
Group B: Part B: Dose expansionExperimental treatment 1 intervention
Group C: Part C: sigvotatug vedotin combination therapy in NSCLC, HNSCC, ESCCExperimental treatment 4 interventions
Group D: Part D: sigvotatug vedotin combination therapy in 1L NSCLCExperimental treatment 3 interventions
Group E: Part D: sigvotatug vedotin combination therapy in 1L HNSCCExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
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

Number of patients with laboratory abnormalities

Time frame
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years
3

Number of participants with dose-limiting toxicities (DLTs)

Time frame
Through 30-37 days following last dose of sigvotatug vedotin; up to 3 years

Secondary outcomes

1

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.

Time frame
Up to approximately 3 years
2

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

Time frame
Up to approximately 3 years
3

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

Time frame
Up to approximately 3 years
4

Overall survival (OS)

The time from the start of any study treatment to the date of death due to any cause

Time frame
Up to approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seagen, a wholly owned subsidiary of Pfizer

Lead sponsor

Source ClinicalTrials.gov
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