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

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Other or Multiple Cancer Types

PF-08046053, SGN-EGFRd2

PF-08046053, SGN-EGFRd2 is an investigational compound. Its safety and efficacy have not been established.

A Phase 1 Study of SGN-EGFRd2 in Advanced Solid Tumors
Phase 1
NCT05983133

Active enrolling

Globe
Locations

United States

Study design

Participant Group/Arm

EXPERIMENTAL: SGN-EGFRd2

SGN-EGFRd2 monotherapy

Intervention/Treatment

DRUG: SGN-EGFRd2

Given into the vein (IV; intravenously)

Key eligibility criteria

Inclusion criteria
  • Tumor types:
    • For Part A: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment. Participants must have histologically- or cytologically confirmed metastatic or unresectable solid malignancy from one of the following tumor types:
  • Tumor types:
    • For Part B: Participants must have disease that is relapsed, refractory, or be intolerant to standard of care therapies, and in the judgement of the investigator must have no appropriate standard therapy available at the time of enrollment.
  • Tumor types:
    • For Part C: Participants must have disease that is relapsed or refractory or be intolerant to standard of care therapies as specified below, unless contraindicated:
  • Participants should provide archival tumor tissue if available and also agree to biopsies, if medically feasible
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Measurable disease at baseline per RECIST 1.1 criteria.
Exclusion criteria
  • History of another malignancy within 3 years before the first dose of study treatment, 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 or leptomeningeal disease. Participants with previously treated brain metastases may participate provided they are
    • clinically stable for at least 4 weeks prior to study entry after brain metastases treatment,
    • they 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 the first dose of study dru
  • Treatment with an aminobisphosphonate IV (eg ibandronate, pamidronate, zoledronate, etc.) within 4 weeks of the first dose of study treatment.
  • Participants with history of thromboembolic phenomena (pulmonary embolism, deep vein thrombosis, stroke, or ischemic attack) within 6 months prior to the first dose of study drug, currently receiving chronic anticoagulation therapy, or with contraindication to treatment for thromboembolism prophylaxis.

Key dates

Study start date
  • November 2023
Estimated primary completion date
  • September 2028

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 subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention

Time Frame

Through 90 days after last study treatment, up to approximately 1 year

Outcome Measure

Number of participants with laboratory abnormalities

Time Frame

Through 30-37 days after last study treatment, up to approximately 1 year

Outcome Measure

Number of participants with dose limiting toxicities (DLTs)

Time Frame

Up to 35 days

Outcome Measure

Number of participants with DLTs by dose level

Time Frame

Up to 35 days

Secondary Outcome Measures:
Outcome Measure

Number of participants with antidrug antibodies (ADAs)

Measure Description

To be summarized using descriptive statistics

Time Frame

Through 30-37 days after last study treatment, up to approximately 1 year

Outcome Measure

Pharmacokinetic (PK) parameter - Area under the curve (AUC)

Measure Description

To be summarized using descriptive statistics

Time Frame

Through 30-37 days after last study treatment, up to approximately 1 year

Outcome Measure

PK parameter - Maximum concentration (Cmax)

Measure Description

To be summarized using descriptive statistics

Time Frame

Through 30-37 days after last study treatment, up to approximately 1 year

Outcome Measure

PK parameter - Time to maximum concentration (Tmax)

Measure Description

To be summarized using descriptive statistics

Time Frame

Through 30-37 days after last study treatment, up to approximately 1 year

Outcome Measure

PK parameter - Apparent terminal half-life (t1/2)

Measure Description

To be summarized using descriptive statistics

Time Frame

Through 30-37 days after last study treatment, up to approximately 1 year

Outcome Measure

PK parameter - Trough concentration (Ctrough)

Measure Description

To be summarized using descriptive statistics

Time Frame

Through 30-37 days after last study treatment, up to approximately 1 year

Outcome Measure

Objective response rate (ORR)

Measure Description

ORR is defined as the proportion of participants with an objective response per Response Evaluation in Solid Tumors (RECIST) 1.1 per investigator. A participant is determined to have an objective response if, based on RECIST 1.1, they achieve a complete response (CR) or partial response (PR) after initiation of treatment and at or prior to the EOT disease assessment.

Time Frame

Up to approximately 2 years

Outcome Measure

Duration of response (DOR)

Measure Description

DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause, whichever comes first

Time Frame

Up to approximately 2 years

Outcome Measure

Progression-free survival (PFS)

Measure Description

PFS is defined as the time from start of SGN-EGFRd2 to first documentation of disease progression or death due to any cause, whichever comes first

Time Frame

Up to approximately 2 years

Outcome Measure

Overall survival (OS)

Measure Description

OS is defined as the time from start of SGN-EGFRd2 to date of death due to any cause

Time Frame

Up to approximately 3 years

Number of participants

275

Collaborators and investigators

Sponsor: Seagen Inc.

Collaborator: None

This information is current as of April 2nd 2024.