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

Cancer Categories

Brain and Nervous System,Gastrointestinal (GI),Lung

Karmanos Trial ID

2023-055

NCT ID

NCT05983133

Age Group

Adult

Scope

National

Phase

Phase I

Principal Investigator

Hirva
Mamdani, M.D.
Lung Cancer Screening, Oncology - Medical View Profile

Objective:

Primary Objectives:

To evaluate the safety and tolerability of SGN-EGFRd2
To identify the maximum tolerated dose (MTD) of SGN-EGFRd2 (Part A)
To identify a recommended dose and schedule for SGN-EGFRd2 (Parts A and B)

Secondary Objectives:

To assess the immunogenicity of SGN-EGFRd2
To assess the PK of SGN-EGFRd2
To assess the antitumor activity of SGN-EGFRd2

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Eligibility

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:

Colorectal cancer (CRC)
Non-small cell lung cancer (NSCLC)
Head and neck squamous cell cancer (HNSCC)-non-nasopharyngeal subtype ONLY; nasopharyngeal subtype is not eligible.

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.

The tumor type(s) to be enrolled in dose optimization will be identified by the sponsor from among those specified in Part A.

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 must have unresectable locally advanced or metastatic CRC.
Prior therapy: Participants must have received prior fluoropyrimidine, oxaliplatin and irinotecan. Participants with defective mismatch repair and microsatellite instability high (dMMR/MSI-H) should have received prior treatment with pembrolizumab, a nivolumab-containing regimen, or other available anti-PD-1 (programmed cell death protein 1) or anti PD L1 (programmed cell death 1 ligand) agents.

NSCLC

Participants must have unresectable locally advanced or metastatic NSCLC.
Prior therapy: Participants must have received platinum-based therapy and at least 1 PD-1/PD-L1 inhibitor. These agents may have been administered either as single agents or in combination. Participants with an activating mutation or rearrangement (eg, EGFR, anaplastic lymphoma kinase [ALK], etc.) must have received available targeted agents if eligible by biomarker status and local standard of care.

HNSCC

Participants must have unresectable locally advanced or metastatic HNSCC - non-nasopharyngeal subtype ONLY; nasopharyngeal subtype is not eligible.
Prior therapy: Participants must have received platinum-based therapy and a PD-1/PD-L1 inhibitor, if eligible by biomarker status and local standard of care. These agents may have been administered either as single agents or in combination.

Pancreatic ductal adenocarcinoma (PDAC)

Participants must have unresectable locally advanced or metastatic PDAC.
Prior therapy: Participants must have received gemcitabine- or FOLFIRINOX-based therapy.

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 drug.

Treatment with an aminobisphosphonate IV (eg ibandronate, pamidronate, zoledronate, etc.) within 4 weeks of the first dose of study treatment.

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

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