A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation

Active:	Yes
Cancer Type:	Breast Cancer Lung Cancer Ovarian Cancer	NCT ID:	NCT05877599
Trial Phases:	Phase I	Protocol IDs:	NT-175-201 (primary) NCI-2023-04428
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	AstraZeneca Pharmaceuticals LP
NCI Full Details:	http://clinicaltrials.gov/show/NCT05877599

Summary

Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to
express an HLA-A*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant
solid tumors.

Objectives

This is a Phase 1, open-label, multicenter study to evaluate the safety and preliminary
antitumor activity of NT-175 in HLA-A*02:01 subjects with unresectable, advanced, and/or
metastatic NSCLC, colorectal adenocarcinoma, HNSCC, pancreatic adenocarcinoma, ovarian
cancer, breast cancer, or any other solid tumor histologies that are positive for the
TP53 R175H mutation.

Dose Escalation will investigate escalating doses of NT-175 in adult subjects with
eligible solid tumor histologies and will evaluate the safety and MTD.

Disease Histology Evaluation will further evaluate the safety and preliminary anti-tumor
activity at or below the MTD in disease specific histologies and determine the RP2D. .

Disease Cohort Expansion will further evaluate the preliminary anti-tumor activity and
safety of NT-175 at the RP2D in disease specific settings.

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

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