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TSC-204-A0201

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment840
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05973487A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 840 — — May 6, 2024Dec 30, 2026Nov 17, 202521 United States
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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 — 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 156 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN9PHASE3Monalizumab, Cetuximab, volrustomig, Volrustomig, Cisplatin
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Remzistotug, Niraparib
Merck & Co., Inc.MRK3PHASE3Pembrolizumab, Cisplatin /m^2, pembrolizumab, Cisplatin, Docetaxel
Johnson & JohnsonJNJ4PHASE3JNJ-90301900, Cetuximab, Amivantamab, Pembrolizumab, Carboplatin
Pfizer Inc.PFE6PHASE2tisotumab vedotin, pembrolizumab, carboplatin, cisplatin, Palbociclib
Regeneron Pharmaceuticals, Inc.REGN4PHASE2cemiplimab, Platinum Doublet, fianlimab, fianlimab+cemiplimab, Cemiplimab
PDS Biotechnology Corp.PDSB1PHASE3Combination Treatment of PDS0101 and Pembrolizumab, Pembrolizumab Monotherapy
Exelixis, Inc.EXEL4PHASE2Zanzalintinib, Pembrolizumab, cabozantinib, atezolizumab, Nivolumab
Merus B.V.MRUS4PHASE3Petosemtamab, Pembrolizumab, MCLA-129, Osimertinib, Chemotherapy
Bristol-Myers Squibb CompanyBMY3PHASE2Nivolumab, Relatlimab, Ipilimumab, Intratumoral Ipilimumab, BMS-986340
Bicara Therapeutics Inc.BCAX3PHASE2Ficerafusp alfa, Nivolumab, Pembrolizumab, BCA101
Gilead Sciences, Inc.GILD2PHASE2Domvanalimab, Zimberelimab, Paclitaxel, Carboplatin
Inhibrx Biosciences, Inc.INBX2PHASE2INBRX-106, Pembrolizumab, INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5
Incyte CorporationINCY1PHASE2Retifanlimab, INCAGN02385, INCAGN02390
BioNTech SE Sponsored ADRBNTX1PHASE2BNT113, Pembrolizumab
Coherus Oncology, Inc.CHRS4PHASE2Toripalimab, Carboplatin, Cisplatin, Paclitaxel, Docetaxel
ALX Oncology Holdings, Inc.ALXO3PHASE2evorpacept, pembrolizumab, Cisplatin/Carboplatin; 5FU, ALX2004
ImmunityBio IncIBRX2PHASE2N-803 + Pembrolizumab, PD-L1 t-haNK, Cetuximab, NAI
Summit Therapeutics IncSMMT2PHASE3Ivonescimab /kg, Ligufalimab, Pembrolizumab, Ivonescimab
IO Biotech, Inc.IOBT1PHASE2IO102-IO103, Pembrolizumab KEYTRUDA
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05973487primaryCompletionDate: changed
LOWMay 24, 2026NCT05973487studyFirstPostDate: changed