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TU2218+ KEYTRUDA

Phase 1

Solid Tumor | Small molecule | Oncology |Merck & Company, Inc.|Trials Updated: Mar 30, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

TU2218+ KEYTRUDA clinical trials

TU2218+ KEYTRUDA · 1 trial · 4 indications

Phase 1 1
NCT05784688Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid TumorsSolid Tumor
RECRUITING140 Analytics
PHASE1RECRUITING
Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors
Solid Tumor
NCT05784688140
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Study Endpoints

Primary Endpoints

Phase 1b: To determine the Recommended Phase 2 Dose of the Combination (RP2DC) of TU2218 given with Pembrolizumab in selected advanced solid tumors
During the first 21-day period (Cycle 1)

At least 1 Dose limiting toxicity (DLT) during Cycle1

Phase 2a: To evaluate the efficacy of TU2218 by evaluating the Overall Response rate (ORR) of TU2218 administered in combination with Pembrolizumab in selected advanced solid tumors
24 weeks

ORR is defined as the proportion of patients with a best overall response of Complete response (CR) or Partial response (PR) according to RECIST v1.1 Efficacy analyses will be performed on both PP and ITT Efficacy Analysis Sets.

Secondary Endpoints

Phase 1b and 2a: To further evaluate the safety and tolerability of TU2218 administered in combination with pembrolizumab.
approximately 13 months
Phase 1b and 2a: The PK of TU2218 administered in combination with pembrolizumab
Cycle 1 (each cycle is 21 days)
Time to Progression (TTP)
over 24 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1b: TU2218 + KEYTRUDA® (Pembrolizumab) in solid tumorEXPERIMENTALTU2218 orally and KEYTRUDA® (Pembrolizumab) intravenously administered daily for two weeks followed by one week to determine RP2DC.
Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in Biliary Tract Cancer (BTC)EXPERIMENTALTU2218 + KEYTRUDA® (Pembrolizumab) administered, orally BID, for 2 weeks followed by 1 week of rest in 3-week cycles for TU2218 and intravenous 200mg once every 3 weeks for KEYTRUDA® (Pembrolizumab)
Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in Head and Neck Squamous Cell Carcinoma (HNSCC)EXPERIMENTALTU2218 + KEYTRUDA® (Pembrolizumab) administered, orally BID, for 2 weeks followed by 1 week of rest in 3-week cycles for TU2218 and intravenous 200mg once every 3 weeks for KEYTRUDA® (Pembrolizumab)
Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in ColoRectal Cancer (CRC)EXPERIMENTALTU2218 + KEYTRUDA® (Pembrolizumab) administered, orally BID, for 2 weeks followed by 1 week of rest in 3-week cycles for TU2218 and intravenous 200mg once every 3 weeks for KEYTRUDA® (Pembrolizumab)

Interventions

NameTypeDescription
TU2218 + KEYTRUDA® (Pembrolizumab)DRUGTU2218: Orally administered KEYTRUDA® (Pembrolizumab): Intravenously administered
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. Male and females ≥18 years of age 2. Life expectancy ≥12 weeks as judged by the Investigator 3. Measurable disease as defined by RECIST v1.1 4. ECOG 0 or 1 5. Able to swallow capsules 6. For Phase 1b and 2a: histologically or cytologically documented advanced unresectable sol...

Countries:United StatesSouth Korea
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumor")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK3PHASE2Pembrolizumab, Gardasil 9
Incyte CorporationINCY1PHASE2Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115
Iovance Biotherapeutics IncIOVA2PHASE2Aldesleukin
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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