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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

Geo Regions

Category

Other or Multiple Cancer Types

Category

Thoracic Cancer

Sigvotatug vedotin (Integrin beta-6 directed Antibody Drug Conjugate)

Sigvotatug vedotin (SGN-B6A) is an investigational compound. Its safety and efficacy have not been established

An Open-label, Phase 1 Study to Investigate the Safety and Pharmacokinetics of SGN-B6A in Chinese Subjects With Advanced Solid Tumors

Phase 1

NCT06549816

Active enrolling

Globe

Locations

China

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Study design
Participant Group/Arm

EXPERIMENTAL: sigvotatug vedotin

sigvotatug vedotin monotherapy 1.8 mg/kg adjusted ideal body weight intravenous administration on Days 1 and 15 of a 28-day cycle.

Intervention/Treatment

DRUG: sigvotatug vedotin

Sigvotatug vedotin is a antibody-drug conjugate (ADC) designed to deliver the cytotoxic agent monomethyl auristatin E (MMAE) to cells expressing integrin beta-6.

Study design table for Clinical Trial
Key eligibility criteria
Inclusion criteria
  • Subjects must have histologically or cytologically confirmed metastatic or unresectable locally advanced solid malignancy within one of the tumor types listed below.
    • NSCLC
    • HNSCC
    • ESCC
    • GAC
    • EAC
    • GEJ adenocarcino
  • Subjects must have disease that is relapsed or refractory, or be intolerant to systemic standard-of-care therapies, and in the judgement of the investigator, should have no appropriate standard-of-care therapeutic option. If a standard-of-care therapy is available that has not been administered, the reason that the therapy is not appropriate must be documented.
  • Adequate organ function as defined by the baseline laboratory criteria obtained within 7 days prior to SGN-B6A initiation (Cycle 1 Day 1)
  • Measurable or non-measurable disease per RECIST v1.1 at baseline.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Exclusion criteria
  • History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
  • Participants with any of the following respiratory conditions:
    • Evidence of noninfectious interstitial lung disease (ILD) or pneumonitis that:
    • \* Was previous diagnosed and required systemic steroids, or
    • \* Is currently diagnosed and managed, or
    • \* Is suspected on radiologic imaging at screening
    • Known diffusing capacity of the lung for carbon monoxide (DLCO) \< 50%
    • Any Grade greater than or equal to (≥) 3 pulmonary disease unrelated to underlying malignancy
    • Prior radiation therapy to the lung that is \>30 gray (Gy) within 6 months of the first dose of sigvotatug vedoti
  • Pre-existing peripheral neuropathy Grade greater than or equal to (≥) 2
  • Uncontrolled diabetes mellitus
  • 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 dru
  • Known history or current diagnosis of carcinomatous meningitis
  • Previous treatment with an MMAE-containing agent or an agent targeting integrin beta-6
  • Prior anticancer therapies:
    • Chemotherapy within 21 days prior to first administration of sigvotatug vedotin
    • Targeted small molecule agents within 14 days or 5 half-lives (whichever is longer) prior to first administration of sigvotatug vedotin
    • Antibody-based anticancer or other investigational antitumor therapy within 28 days prior to first administration of sigvotatug vedotin
    • Focal radiotherapy or major surgery that is not completed 14 days prior to the first dose of sigvotatug vedot
  • Traditional or herbal medicines:
    • Anti-cancer traditional or herbal medicines within 28 days prior to first administration of sigvotatug vedotin
    • Traditional or herbal medicines for other purposes (such as supportive care) within 7 days prior to first administration of sigvotatug vedot
Key dates
Study start date
  • August 2024
Estimated Study Completion Date
  • September 2025
Key endpoints
Primary Outcome Measures
Outcome Measure

Number of participants with adverse events (AEs)

Measure Description

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time Frame

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

Outcome Measure

Number of participants with laboratory abnormalities

Measure Description

Time Frame

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

Outcome Measure

Number of participants with dose-limiting toxicities (DLTs)

Measure Description

Time Frame

Up to 28 days

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Pharmacokinetics (PK) of antibody-conjugated monomethyl auristatin E (ac-MMAE) in plasma: Area under the curve (AUC) after a single dose and multiple doses of SGN-B6A

Measure Description

Time Frame

Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days)

Outcome Measure

PK of ac-MMAE in plasma: maximum concentration (Cmax) after a single dose and multiple doses of SGN-B6A

Measure Description

Time Frame

Single dose: Cycle 1 Day 1 (predose, end of infusion [EOI], and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days)

Outcome Measure

PK of ac-MMAE in plasma: time to maximum concentration (Tmax) after a single dose and multiple doses of SGN-B6A

Measure Description

Time Frame

Single dose: Cycle 1 Day 1 (predose, End of Infusion (EOI), and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days)

Outcome Measure

PK of ac-MMAE in plasma: apparent half-life (t1/2) after a single dose and multiple doses of SGN-B6A

Measure Description

Time Frame

Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days)

Outcome Measure

PK of ac-MMAE in plasma: trough concentration (Ctrough) after a single dose and multiple doses of SGN-B6A

Measure Description

Time Frame

Single dose: Cycle 1 Day 15 predose; Multiple dose: Cycle 2 Day 15 predose (Each Cycle is 28 days)

Outcome Measure

PK of monomethyl auristatin E (MMAE) in plasma - AUC after a single dose and multiple doses of SGN-B6A

Measure Description

Time Frame

Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days)

Outcome Measure

PK of MMAE in plasma: maximum concentration (Cmax) after a single dose and multiple doses of SGN-B6A

Measure Description

Time Frame

Single dose: Cycle 1 Day 1 (predose, end of infusion [EOI], and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days)

Outcome Measure

PK of MMAE in plasma: time to maximum concentration (Tmax) after a single dose and multiple doses of SGN-B6A

Measure Description

Time Frame

Single dose: Cycle 1 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose); Multiple dose: Cycle 2 Day 1 (predose, EOI, and 2 hour and 4 hour post-dose) (Each Cycle is 28 days)

Outcome Measure

PK of MMAE in plasma: apparent half-life (t1/2) after a single dose and multiple doses of SGN-B6A

Measure Description

Time Frame

Single dose: Cycle 1 Day 1 through predose Cycle 1 Day 15; Multiple dose: Cycle 2 Day 1 through predose Cycle 2 Day 15 (Each Cycle is 28 days)

Outcome Measure

PK of MMAE in plasma: trough concentration (Ctrough) after a single dose and multiple doses of SGN-B6A

Measure Description

Time Frame

Single dose: Cycle 1 Day 15 predose; Multiple dose: Cycle 2 Day 15 predose (Each Cycle is 28 days)

Outcome Measure

Number of participants with antidrug antibodies

Measure Description

Time Frame

From first dose through up to 37 days following last dose of sigvotatug vedotin

Secondary Outcome Measures table for Clinical Trial
Number of participants

12

Collaborators and investigators

Sponsor: Seagen Inc.

Collaborator: None

This information is current as of October 16th 2024.

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When calling, please reference this study number:

More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT06549816