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EMB-01

Phase 1

Neoplasms | Small molecule | Oncology |Labcorp Holdings Inc.|Last Updated: Aug 26, 2024

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment152
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05176665EMB-01 in Patients With Advanced/Metastatic Gastrointestinal CancersPHASE1 RECRUITING 152 — — Oct 21, 2021Dec 31, 2025Aug 26, 202414 United States, China
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Study Endpoints
Primary Endpoints
Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
Phase 1b, screening up to follow-up (30 days after the last dose)
Best Overall Response (BOR) as assessed by RECIST v1.1
Phase II, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Objective Response Rate (ORR) as assessed by RECIST v1.1
Phase II, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Duration of Response (DoR) as assess by RECIST v1.1 as assess by RECIST v1.1
Phase II, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Disease Control Rate (DCR) as assess by RECIST v1.1
Phase II, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Progression-Free Survival (PFS) as assess by RECIST v1.1
Phase II, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Maximum serum concentration (Cmax) of EMB-01
Phase Ib only, up to 3 months after first study drug administration
Trough serum concentration (Ctrough) of EMB-01
Phase Ib only, predose, through treatment completion, an average of 1 year
Area under the concentration-time curve from time 0 (pre-dose) to the time of the dosing interval (AUC0-t)
Phase Ib only, up to 3 months after first study drug administration
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Phase Ib only, up to 3 months after first study drug administration
Elimination half-life (T1/2)
Phase Ib only, up to 3 months after first study drug administration
Systemic clearance (CL)
Phase Ib only, up to 3 months after first study drug administration
Apparent volume of distribution at steady-state (Vss)
Phase Ib only, up to 3 months after first study drug administration
Accumulation Ratio (AR) after multiple dosing
Phase Ib only, up to 3 months after first study drug administration
Incidence of positive ADA
Phase Ib only, up to the 30-day safety follow-up visit after EOT
Clinical benefit rate(CBR) as assess by RECIST v1.1
Phase II, from the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Secondary Endpoints
Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0
Phase II, screening up to follow-up (30 days after the last dose)
Maximum serum concentration (Cmax) of EMB-01
Phase II, up to 3 months after first study drug administration
Trough serum concentration (Ctrough) of EMB-01
Phase II, predose, through treatment completion, an average of 1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase Ib and Phase IIEXPERIMENTALThe study will consist of Phase Ib and Phase II. The study is planning to recruit approximately 152 patients in total for advanced/metastatic GI cancers, which include 24 patients in Phase Ib and up to approximately 128 patients in Phase II. For GC, HCC, and BTC groups, up to approximately 24 patients may be enrolled in Phase Ib and Phase II. For CRC group, up to approximately 80 patients may be enrolled in Phase Ib and Phase II with up to 40 patients in each subgroup.
Interventions
NameTypeDescription
EMB-01DRUGEMB-01 at the RP2D of 1600 mg will be administered as an IV infusion once weekly (QW) throughout the study. One cycle is defined as 4 weeks (4 doses).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: Molecular Pre-screening Inclusion criteria 1. cMET amplification in tumor sample; OR 2. cMET overexpression in tumor sample; OR 3. EGFR overexpression in tumor sample; OR 4. Other EGFR or cMET gene alteration in blood sample (circulating tumor DNA, ctDNA). In Phase II, CRC pat...

Countries:United StatesChina
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Competitive Landscape -Myeloproliferative Neoplasms 53 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY5PHASE3ACE-536, Luspatercept, Fedratinib, BMS-986158, Ruxolitinib
AbbVie, Inc.ABBV4PHASE3Navitoclax, Ruxolitinib, Celecoxib, ABBV-744, IMGN632
Novartis AG Sponsored ADRNVS3PHASE3Pelabresib, Ruxolitinib
Karyopharm Therapeutics, Inc.KPTI4PHASE3Selinexor, Ruxolitinib, Pacritinib, Momelotinib
Geron CorporationGERN2PHASE3Imetelstat, Ruxolitinib
Incyte CorporationINCY11PHASE2itacitinib, Ruxolitinib, Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C
Merck & Co., Inc.MRK1PHASE3Bomedemstat
GSK plc Sponsored ADRGSK2PHASE2MMB, Momelotinib, Luspatercept
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE2Elritercept, Ruxolitinib
Eli Lilly and CompanyLLY1PHASE1LY3410738, Venetoclax, Azacitidine
Disc Medicine, Inc.IRON1PHASE1DISC-0974
Galecto, Inc.GLTO1PHASE2GB2064
Prelude Therapeutics, Inc.PRLD1PHASE1PRT12396
United Therapeutics CorporationUTHR1PHASE2bomedemstat
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05176665primaryCompletionDate: changed
LOWMay 24, 2026NCT05176665studyFirstPostDate: changed