A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation

Active:	Yes
Cancer Type:	Breast Cancer Cancer-Related Syndrome Leukemia Lung Cancer Myelodysplastic Syndromes (MDS) 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
malignancies

Objectives

This is a Phase 1, open-label, multicentre platform study to evaluate the safety and
preliminary antitumour activity of NT-175 in HLA-A*02:01 participants with advanced
malignancies that are positive for the TP53 R175H mutation.

Dose Escalation will investigate escalating doses of NT-175 in adult subjects with
eligible histologies and will evaluate the safety and MTD and/or RDE/RP2D.

Cohort expansion will further evaluate the safety and preliminary anti-tumour activity at
or below the MTD in disease specific histologies and determine the RP2D.

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

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