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
Breast Cancer
Lung Cancer
Ovarian Cancer
18 Years and older, Male and Female
NT-175-201 (primary)
NCI-2023-04428
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.
Eligibility
- Subjects must be at least 18 years of age, at the time of signing the informed consent.
- Subjects must be capable of giving signed informed consent.
- Subject must be diagnosed with one of the histologies below:
- NSCLC
- Colorectal adenocarcinoma
- HNSCC
- Pancreatic adenocarcinoma
- Breast cancer
- Ovarian cancer
- Any other solid tumor
- Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A*02:01 positive (at least 1 allele) as confirmed by an CLIA-accredited laboratory-based test.
- Subject has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.
- Subject has at least 1 measurable lesion per computed tomography (CT) scan or magnetic resonance imaging (MRI) per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment
- Adequate hematological, renal, hepatic, pulmonary, and cardiac function
- Per Investigator judgement, subject is likely to complete study visits and/or procedures per the protocol and comply with study requirements for study participation Key
Treatment Sites in Georgia
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