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
Bispecific Gamma Delta-T-Cell Engager Directed to EGFR
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
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