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TSC-204-A0201

Phase 1

Head and Neck Cancer | Monoclonal antibody | Oncology |TScan Therapeutics, Inc.|Last Updated: Nov 17, 2025

Target and mechanism

Molecular targetMAGE-A1
Target classProtein
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment840

FDA Designations

No designations recorded

Clinical trial landscape

TSC-204-A0201 · 1 trial · 21 indications

Phase 1 1
NCT05973487A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid TumorsHead and Neck Cancer
ACTIVE NOT_RECRUITING840 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors
Head and Neck Cancer
NCT05973487840
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Study Endpoints

Primary Endpoints

Evaluate the safety of monotherapy and T- Plex combination TCR-Ts
28 days

Number of subjects with dose limiting toxicities (DLT)

Determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts
Up to 12 months

Frequency and severity of DLTs, AEs and SAEs

Secondary Endpoints

Investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts
Up to 12 months
Investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts
Up to 12 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Monotherapy Cohort AEXPERIMENTALTSC-204-A0201
Monotherapy Cohort BEXPERIMENTALTSC-204-C0702
Monotherapy Cohort CEXPERIMENTALTSC-200-A0201
T-Plex Combination Cohort A + BEXPERIMENTALTSC-204-A0201 and TSC-204-C0702
T-Plex Combination Cohort B + CEXPERIMENTALTSC-204-C0702 and TSC-200-A0201
T-Plex Combination Cohort A + CEXPERIMENTALTSC-204-A0201 and TSC-200-A0201
Monotherapy Cohort DEXPERIMENTALTSC-203-A0201
T-Plex Combination Cohort A + DEXPERIMENTALTSC-204-A0201 + TSC-203-A0201
T-Plex Combination Cohort B + DEXPERIMENTALTSC-204-C0702 + TSC-203-A0201
Monotherapy Cohort EEXPERIMENTALTSC-204-A0101
Monotherapy Cohort FEXPERIMENTALTSC-201-B0702
T-Plex Combination Cohort A + EEXPERIMENTALTSC-204-A0201 + TSC-204-A0101
T-Plex Combination Cohort A + FEXPERIMENTALTSC-204-A0201 + TSC-201-B0702
T-Plex Combination Cohort B + EEXPERIMENTALTSC-204-C0702 + TSC-204-A0101
T-Plex Combination Cohort B + FEXPERIMENTALTSC-204-C0702 + TSC-201B0702
T-Plex Combination Cohort C + DEXPERIMENTALTSC-200-A0201 + TSC-203-A0201
T-Plex Combination Cohort C + EEXPERIMENTALTSC-200-A0201 + TSC-204-A0101
T-Plex Combination Cohort C + FEXPERIMENTALTSC-200-A0201 + TSC-201B0702
T-Plex Combination Cohort D + EEXPERIMENTALTSC-203-A0201 + TSC-204A0101
T-Plex Combination Cohort D + FEXPERIMENTALTSC-203-A0201 + TSC-201B0702
T-Plex Combination Cohort E + FEXPERIMENTALTSC-204-A0101 + TSC-201-B0702
Monotherapy Cohort GEXPERIMENTALTSC-202-A0201
T-Plex Combination Cohort A + GEXPERIMENTALTSC-204-A0201 + TSC-202-A0201
T-Plex Combination Cohort B + GEXPERIMENTALTSC-204-C0702 + TSC-202-A0201
T-Plex Combination Cohort C+ GEXPERIMENTALTSC-200-A0201 + TSC-202-A0201
T-Plex Combination Cohort D + GEXPERIMENTALTSC-203-A0201 + TSC-202-A0201
T-Plex Combination Cohort E + GEXPERIMENTALTSC-204-A0101 + TSC-202-A0201
T-Plex Combination Cohort F + GEXPERIMENTALTSC-201-B0702 + TSC-202-A0201

Interventions

NameTypeDescription
TSC-204-A0201BIOLOGICALEscalating doses of TSC-204-A0201 as a monotherapy
TSC-204-C0702BIOLOGICALEscalating doses of TSC-204-C0702 as a monotherapy
TSC-200-A0201BIOLOGICALEscalating doses of TSC-200-A0201 as a monotherapy
TSC-204-A0201 + TSC-204-C0702BIOLOGICALEscalating doses of TSC-204-A0201 in combination with TSC-204-C0702
TSC-204-A0201 + TSC-200-A0201BIOLOGICALEscalating doses of TSC-204-A0201 in combination with TSC-200-A0201
TSC-204-C0702 + TSC-200-A0201BIOLOGICALEscalating doses of TSC-204-C0702 in combination with TSC-200-A0201
TSC-204-A0201 + TSC-203-A0201BIOLOGICALEscalating doses of TSC-204-A0201 in combination with TSC-203-A0201
TSC-204-C0702 + TSC-203-A0201BIOLOGICALEscalating doses of TSC-204-C0702 in combination with TSC-203-A0201
TSC-200-A0201 + TSC-203-A0201BIOLOGICALEscalating doses of TSC-200-A0201 in combination with TSC-203-A0201
TSC-203-A0201BIOLOGICALEscalating doses of TSC-203-A0201 as a monotherapy
TSC-204-A0101BIOLOGICALEscalating doses of TSC-204-A0101 as a monotherapy
TSC-201-B0702BIOLOGICALEscalating doses of TSC-201-B0702 as a monotherapy
TSC-204-A0201 + TSC-204-A0101BIOLOGICALEscalating doses of TSC-204-A0201 in combination with TSC-204-A0101
TSC-204-A0201 + TSC-201-B0702BIOLOGICALEscalating doses of TSC-204-A0201 in combination with TSC-201-B0702
TSC-204-C0702 + TSC-204-A0101BIOLOGICALEscalating doses of TSC-204-C0702 in combination with TSC-204-A0101
TSC-204-C0702 + TSC-201-B0702BIOLOGICALEscalating doses of TSC-204-C0702 in combination with TSC-201-B0702
TSC-200-A0201 + TSC-204-A0101BIOLOGICALEscalating doses of TSC-200-A0201 in combination with TSC-204-A0101
TSC-200-A0201 + TSC-201-B0702BIOLOGICALEscalating doses of TSC-200-A0201 in combination with TSC-201-B0702
TSC-203-A0201 + TSC-204-A0101BIOLOGICALEscalating doses of TSC-203-A0201 in combination with TSC-204-A0101
TSC-203-A0201 + TSC-201-B0702BIOLOGICALEscalating doses of TSC-203-A0201 in combination with TSC-201-B0702
TSC-202-A0201BIOLOGICALEscalating doses of TSC-202-A0201 as a monotherapy
TSC-204-A0201 + TSC-202-A0201BIOLOGICALEscalating doses of TSC-204-A0201 in combination with TSC-202-A0201
TSC-204-C0702 + TSC-202-A0201BIOLOGICALEscalating doses of TSC-204-C0702 in combination with TSC-202-A0201
TSC-200-A0201 + TSC-202-A0201BIOLOGICALEscalating doses of TSC-200-A0201 in combination with TSC-202-A0201
TSC-203-A0201 + TSC-202-A0201BIOLOGICALEscalating doses of TSC-203-A0201 in combination with TSC-202-A0201
TSC-204-A0101 + TSC-202-A0201BIOLOGICALEscalating doses of TSC-204-A0101 in combination with TSC-202-A0201
TSC-201-B0702 + TSC-202-A0201BIOLOGICALEscalating doses of TSC-201-B0702 in combination with TSC-202-A0201
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: 1. Must be at least 18 years. 2. Locally advanced (unresectable) or metastatic solid tumor for which there are no available curative treatment options, after failure of the standard of care systemic therapies for that particular indication. 3. Solid tumors, including but not lim...

Countries:United States
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Competitive Landscape -Head and Neck Cancer 149 trials

Top 20 of 56 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN9PHASE3Monalizumab, Cetuximab
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab
Johnson & JohnsonJNJ4PHASE3JNJ-90301900, Cetuximab
Merck & Co., Inc.MRK3PHASE3Pembrolizumab, Cisplatin/m^2
Pfizer Inc.PFE6PHASE2tisotumab vedotin, pembrolizumab, carboplatin, cisplatin
Regeneron Pharmaceuticals, Inc.REGN4PHASE2cemiplimab, Platinum Doublet, fianlimab
Exelixis, Inc.EXEL4PHASE2Zanzalintinib, Pembrolizumab
Merus B.V.MRUS4PHASE3Petosemtamab
Bristol-Myers Squibb CompanyBMY3PHASE2Nivolumab, Relatlimab, Ipilimumab
Bicara Therapeutics Inc.BCAX3PHASE2Ficerafusp alfa, Nivolumab
Gilead Sciences, Inc.GILD2PHASE2Domvanalimab, Zimberelimab, Paclitaxel, Carboplatin
Inhibrx Biosciences, Inc.INBX2PHASE2INBRX-106, Pembrolizumab
BioNTech SE Sponsored ADRBNTX1PHASE2BNT113, Pembrolizumab
Incyte CorporationINCY1PHASE2Retifanlimab, INCAGN02385, INCAGN02390
Coherus Oncology, Inc.CHRS3PHASE2Toripalimab, Carboplatin, Cisplatin, Paclitaxel
ALX Oncology Holdings, Inc.ALXO3PHASE2evorpacept, pembrolizumab, Cisplatin/Carboplatin; 5FU
Summit Therapeutics IncSMMT2PHASE3Ivonescimab/kg, Ligufalimab, Pembrolizumab
ImmunityBio IncIBRX1PHASE2N-803, Pembrolizumab
IO Biotech, Inc.IOBT1PHASE2IO102-IO103, Pembrolizumab KEYTRUDA
Eli Lilly and CompanyLLY2PHASE1LY4101174
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Frequently asked questions about TSC-204-A0201

What is TSC-204-A0201 used for?

TSC-204-A0201 is an investigational monoclonal antibody being developed for the treatment of head and neck cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with locally advanced (unresectable) or metastatic solid tumors.

What does TSC-204-A0201 target?

TSC-204-A0201 targets MAGE-A1, a protein that is expressed in certain tumors. By targeting MAGE-A1, the drug is designed to recognize and attack cancer cells that express this protein. This mechanism is being evaluated in a Phase 1 clinical trial for head and neck cancer.

Who makes TSC-204-A0201?

TSC-204-A0201 is being developed by TScan Therapeutics, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol TCRX. TScan Therapeutics is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is TSC-204-A0201 in?

TSC-204-A0201 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trial is currently active but not recruiting patients, and it is designed to assess the drug's safety, tolerability, and preliminary efficacy.

What clinical trials is TSC-204-A0201 in?

TSC-204-A0201 is being studied in a Phase 1 clinical trial with the identifier NCT05973487. This is a basket study of customized autologous TCR-T cell therapies in patients with locally advanced (unresectable) or metastatic solid tumors, including head and neck cancer. The trial is enrolling approximately 840 participants in the United States.

Is TSC-204-A0201 the same as TSC-204?

TSC-204-A0201 is a specific version of the drug TSC-204, with the suffix A0201 indicating a particular variant or formulation. The drug is being developed by TScan Therapeutics for the treatment of head and neck cancer. It is currently in Phase 1 clinical trials and is not yet approved.

Other drugs targeting MAGE-A1

TSC-204-A0101 TCRX· PHASE1 TSC-204-C0702 TCRX· PHASE1