A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors

Cancer Categories

Breast,Gastrointestinal (GI),Head and Neck,Lung

Karmanos Trial ID

2023-045

NCT ID

NCT05208762

Age Group

Adult

Scope

National

Phase

Phase I

Principal Investigator

Ammar
Sukari, M.D.
Oncology - Medical View Profile

Objective:

Primary Objectives:

To evaluate the safety and tolerability of SGN-PDL1V in subjects with advanced solid tumors.
To identify the maximum tolerated dose (MTD) of SGN-PDL1V in subjects with advanced solid tumors.
To identify a recommended dose and schedule for SGN-PDL1V.

Secondary Objectives:

To assess the antitumor activity of SGN-PDL1V.
To assess the pharmacokinetics (PK) of SGN-PDL1V.
To assess the immunogenicity of SGN-PDL1V.

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Eligibility

Inclusion Criteria:

Parts A and B:

Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types

Non-small cell lung cancer (NSCLC)
Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)
Esophageal squamous cell carcinoma (SCC)
Triple negative breast cancer (TNBC)

Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option
Participants must have PD-L1 expression based on historical testing

Part C:

Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types

HNSCC

Participants with HNSCC must have histologically or cytologically-confirmed HNSCC

NSCLC

Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.

Esophageal SCC
Ovarian cancer
Melanoma
TNBC
Gastric cancer

Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or <1 by CPS or TPS based on historical testing

Part D and Part E:

Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC
Participants must have PD-L1 expression based on historical testing
Participants with NSCLC; PD-L1 expression ≥ 1% by TPS
Participants with HNSCC; PD--L1 expression ≥1 by CPS

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Measurable disease per RECIST v1.1 at baseline

Exclusion Criteria:

History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
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 associate with brain metastases for at least 7 days prior to first dose of study treatment

Lepto-meningeal disease
Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.
Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

Locations

Karmanos Cancer Institute - Detroit Headquarters

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

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

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

Applicable Disease Site

Therapies, Drugs, Devices