An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer

Cancer Categories

Lung

Karmanos Trial ID

2024-024

NCT ID

NCT06179069

Age Group

Adult

Scope

National

Phase

Phase I

Principal Investigator

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

Objective:

Primary Objective:

To characterize the safety and tolerability of different dose levels of ZL-1310, including dose‑limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose (RD).

Secondary Objectives:

To assess the preliminary efficacy of ZL-1310.
To characterize the pharmacokinetics (PK) of ZL-1310 as a single agent, after a single dose and multiple doses.

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Eligibility

Inclusion Criteria:

Signed informed consent
Subjects must have histologically or cytologically confirmed metastatic or extensive-stage small cell lung cancer with documented disease progression during or following a platinum-based chemotherapy regimen. No more than 3 prior regimens in the metastatic or extensive stage are allowed.
Adult men and women ≥18 years of age. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Subjects must have at least one measurable target lesion as defined by RECIST v1.1 on CT, PET/CT, or MRI.
Subjects must be willing to undergo a tumor biopsy or must provide archived tumor tissue sample at screening per protocol guidelines.
Life Expectancy >3 months.

Exclusion Criteria:

Subjects with another known malignancy that is progressing or requires active treatment within the last 2 years. Exceptions: basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin with previously administered curative treatment, in situ cervical cancer, or other cancers that do not require systemic anti-cancer therapies and will not impact life expectancy.
Symptomatic or untreated brain metastasis requiring concurrent treatment.
Subjects with leptomeningeal metastasis.
Treatment with any systemic anti-cancer treatment or other investigational products/ device within 3 weeks before first dose of study treatment.
Non-palliative radiotherapy within 2 weeks prior to first dose of study treatment or have had a history of radiation pneumonitis.
Major surgery within 4 weeks of the first dose of study treatment.
Hypersensitivity to any ingredient of the study treatment.
Out of range lab value (as defined in protocol) within 10 days prior to the first dose of study treatment,
Subjects with a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 14 days or 5 half-lives before the first dose of study treatment, whichever is longer.
Subjects have received a live or live-attenuated vaccine within 30 days of planned start of study therapy.
Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study treatment
Lung-specific intercurrent clinically significant illnesses and any autoimmune, connective tissue, or inflammatory disorders, including not limited to pneumonitis.
Pregnant or nursing (lactating) women.

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