Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT06218914
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NT-112: Autologous, engineered T Cells targeting KRAS G12D — BIOLOGICAL
    NT-112 targets KRAS G12D in the context of HLA-C\*08:02
  • AZD0240: Autologous, engineered T Cells targeting KRAS G12D — BIOLOGICAL
    AZD0240 targets KRAS G12D in the context of HLA-A\*11:01 or HLA-A\*11:02

Study Details

Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.

Key Dates

Start date
Mar 22, 2024
Status verified
May 2026
Primary completion
Aug 30, 2027
Completion
Nov 18, 2043

Study Design

Enrollment
108 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NT-112
    Part A Dose Escalation and Part B Dose Expansion of NT-112
  • Experimental: AZD0240
    Part A Dose Escalation and Part B Dose Expansion of AZD0240

Primary Outcome Measure

Part A (Dose Escalation): Evaluate the safety of KRAS TCRTs in subjects with unresectable, advanced, and/or metastatic solid tumors [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteLos AngelesCalifornia90095-
Research SiteNewport BeachCalifornia92663-
Research SiteJacksonvilleFlorida32224-
Research SiteChicagoIllinois60637-
Research SiteWestwoodKansas66205-
Research SiteBostonMassachusetts02115-
Research SiteSt LouisMissouri63110-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10065-
Research SitePortlandOregon97213-
Research SitePhiladelphiaPennsylvania19107-
Research SitePittsburghPennsylvania15237-
Research SiteNashvilleTennessee37203-
Research SiteDallasTexas75246-
Research SiteGalvestonTexas77555-
Research SiteHoustonTexas77030-
Research SiteMilwaukeeWisconsin53226-

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