A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid Tumors

Trial number:
NCT05462873
Trial phase:
1
Study type:
Any
Overall status:
Recruiting

Study start date

April, 2023

Scientific title

A Phase I/Ib, Open-label, Multi-center, Study of QEQ278 in Patients With Advanced Solid Tumors

Summary

To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma.

Signed informed consent must be obtained prior to participation in the study.Adult men and women ≥ 18 years of age. Histologically confirmed and documented advanced malignancies (locally advanced malignancies, non-curable by surgery or radiotherapy and metastatic disease). Disease must be measurable, including presence of at least one measurable lesion, as determined by RECIST v1.1. In the opinion of the treating investigator, patients must have received, but are not benefitting from standard therapies, be intolerant or ineligible to receive such therapy, or have no standard therapy option for the respective disease types (diseases listed below), as well as any other therapies deemed to be standard by local/institutional standard. Non-small cell lung cancer Esophageal squamous cell carcinoma Renal cell carcinoma HPV-associated head and neck squamous cell carcinoma Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. The patient must be willing to undergo a new tumor biopsy at screening and during treatment.

Study design

Primary purpose: Treatment, Allocation: Non-Randomized, Intervention model: Single Group Assignment, Masking: None (Open Label),

Conditions

Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck

Other study ID numbers

CQEQ278A12101

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