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GI-101

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: May 15, 2026

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment317
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04977453GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid TumorsPHASE1 RECRUITING 317 — — Aug 2, 2021Jun 30, 2028May 15, 202612 United States, South Korea
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Study Endpoints
Primary Endpoints
Incidence and nature of Dose-Limiting Toxicity (DLTs), Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs)
Study Day 1, assessed up to approximately 24 months

Dose escalation and optimization phase of Part A, B, and C and Dose escalation phase of Part E and F

Objective Response Rate (ORR), Disease Control Rate (DCR) and Duration of Response (DoR) according to RECIST version 1.1
Study Day 1, assessed up to approximately 24 months

Based on Central review (Part G1) and Investigator review (Part G2) of radiographic imaging in Part G1 Dose optimization cohorts, Part G2 Indication-specific cohorts ORR only; Based on Investigator review of radiographic imaging in dose expansion phase of Part A, B and C

Secondary Endpoints
Serum concentration of GI-101/GI-101A at specified timepoints
Study Day 1, assessed up to approximately 24 months
Anti-tumor activities
Study Day 1, assessed up to approximately 24 months
Incidence, nature, and severity of adverse events (AEs) graded according to CTCAE v5.0
Study Day 1, assessed up to approximately 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GI-101EXPERIMENTALDose escalation: GI-101, multiple ascending doses Dose expansion:
GI-101 + PembrolizumabEXPERIMENTALDose escalation: GI-101, multiple ascending doses Dose expansion:
GI-101 + LenvatinibEXPERIMENTALDose optimization: Dose expansion:
GI-101AEXPERIMENTALDose escalation: GI-101A, multiple ascending doses
GI-101A + PembrolizumabEXPERIMENTALDose escalation: GI-101A, multiple ascending doses Dose optimization Indication-specific cohorts
Interventions
NameTypeDescription
GI-101DRUGRecommended phase 2 dose of GI-101 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
Pembrolizumab (KEYTRUDA®)DRUGPembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.
LenvatinibDRUGLenvatinib will be administered at an approved dose orally.
GI-101ADRUGRecommended phase 2 dose of GI-101A will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Key Inclusion Criteria: * Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening. * Has adequate organ and marrow function as defined in protocol. * Measurable disease as per RECIST v1.1. * ECOG performance status 0-1. * Adverse events re...

Countries:United StatesSouth Korea
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04977453studyFirstPostDate: changed