Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors

Part of paid clinical trials in San Antonio, Texas.

Sponsor
TiumBio Co., Ltd.
Study ID
NCT05784688
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • TU2218 + KEYTRUDA® (Pembrolizumab) — DRUG
    TU2218: Orally administered KEYTRUDA® (Pembrolizumab): Intravenously administered

Study Details

This study consists of phase 1b and 2a to evaluate safety, Pharmacokinetics, and efficacy of TU2218 in combination with Pembrolizumab in patients with advanced solid tumors.

Key Dates

Start date
Mar 10, 2023
Status verified
Feb 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Phase 1b: TU2218 + KEYTRUDA® (Pembrolizumab) in solid tumor
    TU2218 orally and KEYTRUDA® (Pembrolizumab) intravenously administered daily for two weeks followed by one week to determine RP2DC.
  • Experimental: Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in Biliary Tract Cancer (BTC)
    TU2218 + 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)
  • Experimental: Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in Head and Neck Squamous Cell Carcinoma (HNSCC)
    TU2218 + 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)
  • Experimental: Phase 2a: TU2218 + KEYTRUDA® (Pembrolizumab) in ColoRectal Cancer (CRC)
    TU2218 + 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)

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
NEXT OncologySan AntonioTexas78229-3307-
Hope Cancer CenterTylerTexas75701-
Medical OncologySpokaneWashington99208-

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