Recent Updates
Recently added Catalysts

NT-112

Phase 1

Non-small Cell Lung Cancer | Monoclonal antibody | Oncology |AstraZeneca PLC|Trials Updated: Sep 25, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

NT-112 clinical trials

NT-112 · 1 trial · 6 indications

Phase 1 1
NCT06218914Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid TumorsNon-small Cell Lung Cancer
RECRUITING108 Analytics
PHASE1RECRUITING
Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Incidence of DLTs, treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Part A (Dose Escalation): Evaluate MTD and recommended dose for expansion (RDE)
28 days after infusion

Incidence of DLTs, treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Part B (Expansion): Further evaluate the safety of KRAS TCRTs at the RDE in subjects with unresectable, advanced, and/or metastatic solid tumors
28 days after infusion

Incidence of DLTs, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)

Secondary Endpoints

Part A (Dose Escalation): Evaluate the preliminary anti-tumor activity of KRAS TCRTs in subjects with unresectable, advanced, and/or metastatic solid tumors
Up to 24 months post-infusion
Part B (Dose Expansion): Evaluate the preliminary anti-tumor activity of KRAS TCRTs at the RDE in subjects with unresectable, advanced, and/or metastatic solid tumors
Up to 24 months post infusion
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NT-112EXPERIMENTALPart A Dose Escalation and Part B Dose Expansion of NT-112
AZD0240EXPERIMENTALPart A Dose Escalation and Part B Dose Expansion of AZD0240

Interventions

NameTypeDescription
NT-112: Autologous, engineered T Cells targeting KRAS G12DBIOLOGICALNT-112 targets KRAS G12D in the context of HLA-C\*08:02
AZD0240: Autologous, engineered T Cells targeting KRAS G12DBIOLOGICALAZD0240 targets KRAS G12D in the context of HLA-A\*11:01 or HLA-A\*11:02
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Key Inclusion Criteria: * Age ≥18 years * Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor * Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C\*08:02 positive, HLA-A\*11:01 or HLA-A\*11:02 positive in at ...

Countries:United States
Unlock Eligibility Criteria

Competitive Landscape -Non-Small Cell Lung Cancer 544 trials

Top 20 of 90 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK37PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Intismeran autogene, Pembrolizumab Berahyaluronidase alfa
Revolution Medicines, Inc.RVMD9PHASE3Daraxonrasib, Zoldonrasib, Elironrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV12PHASE3Telisotuzumab vedotin, ABBV-1480, Livmoniplimab, Budigalimab, Telisotuzumab Adizutecan
AstraZeneca PLCAZN68PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Gilead Sciences, Inc.GILD7PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant, TUB-040- Dose escalation
Bristol-Myers Squibb CompanyBMY24PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
Johnson & JohnsonJNJ19PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Pfizer Inc.PFE20PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS11PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, KFA115
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Regeneron Pharmaceuticals, Inc.REGN7PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
BeOne Medicines Ltd. Sponsored ADRONC7PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
Unlock Competitive Intelligence

Recent Changes (Last 90 Days)

LOWSep 25, 2026NCT06218914lastUpdatePostDate: changed
LOWSep 25, 2026NCT06218914lastUpdatePostDate: changed
LOWAug 24, 2026NCT06218914lastUpdatePostDate: changed
LOWAug 24, 2026NCT06218914lastUpdatePostDate: changed

Frequently asked questions about NT-112

What is NT-112?

NT-112 is an investigational cell therapy being developed by AstraZeneca PLC (ticker AZN) for the treatment of KRAS G12D-mutant solid tumors, including non-small cell lung cancer. It is an autologous, engineered T cell therapy designed to target the KRAS G12D mutation. NT-112 is currently in Phase 1 clinical development.

What is NT-112 used for in non-small cell lung cancer?

NT-112 is being studied for the treatment of non-small cell lung cancer that is unresectable, advanced, or metastatic and carries a KRAS G12D mutation. It is also being evaluated in other KRAS G12D-positive solid tumors, including colorectal carcinoma, pancreatic ductal adenocarcinoma, and endometrial cancer. NT-112 is investigational and has not been approved for any indication.

What does NT-112 target?

NT-112 targets the KRAS G12D mutation. It is an autologous, engineered T cell therapy, meaning a patient's own T cells are modified to recognize and attack cancer cells expressing this specific mutation. The KRAS G12D mutation is a driver alteration found in several solid tumor types, including non-small cell lung cancer.

Who is developing NT-112?

NT-112 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the ongoing Phase 1 clinical trial evaluating NT-112 in patients with KRAS G12D-mutant solid tumors.

What phase is NT-112 in?

NT-112 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA or any regulatory authority. The Phase 1 trial is currently recruiting participants.

What clinical trials is NT-112 in?

NT-112 is being evaluated in a Phase 1 clinical trial, NCT06218914, titled "Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors." The trial is recruiting and plans to enroll 108 participants in the United States. It includes patients with non-small cell lung cancer, colorectal carcinoma, pancreatic ductal adenocarcinoma, endometrial cancer, and other KRAS G12D-positive solid tumors.