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EMB-01

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED

Total Trials1

Total Enrollment152

FDA Designations

No designations recorded

Clinical trial landscape

EMB-01 · 1 trial · 3 indications

Phase 1 1

Indication

NCT05176665EMB-01 in Patients With Advanced/Metastatic Gastrointestinal CancersNeoplasms

RECRUITING152 Analytics

PHASE1RECRUITING

EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers

Neoplasms

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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

Arm	Type	Description
Phase Ib and Phase II	EXPERIMENTAL	The 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

Name	Type	Description
EMB-01	DRUG	EMB-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 to 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 52 trials (matched to "Neoplasms")

Company	Ticker	Trials	Lead Phase	Drugs
Bristol-Myers Squibb Company	BMY	5	PHASE3	ACE-536
AbbVie, Inc.	ABBV	4	PHASE3	Navitoclax, Ruxolitinib
Novartis AG Sponsored ADR	NVS	3	PHASE3	Pelabresib, Ruxolitinib
Karyopharm Therapeutics, Inc.	KPTI	4	PHASE3	Selinexor, Ruxolitinib
Geron Corporation	GERN	2	PHASE3	Imetelstat
Merck & Co., Inc.	MRK	1	PHASE3	Bomedemstat
Incyte Corporation	INCY	10	PHASE2	Ruxolitinib
GSK plc Sponsored ADR	GSK	2	PHASE2	MMB
Takeda Pharmaceutical Co. Ltd. Sponsored ADR	TAK	1	PHASE2	Elritercept, Ruxolitinib
Eli Lilly and Company	LLY	1	PHASE1	LY3410738, Venetoclax, Azacitidine
Disc Medicine, Inc.	IRON	1	PHASE1	DISC-0974
Galecto, Inc.	GLTO	1	PHASE2	GB2064
Prelude Therapeutics, Inc.	PRLD	1	PHASE1	PRT12396
United Therapeutics Corporation	UTHR	1	PHASE2	bomedemstat

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Frequently asked questions about EMB-01

What is EMB-01 used for?

EMB-01 is an investigational small molecule being studied for the treatment of neoplasms, specifically advanced or metastatic gastrointestinal cancers, including metastatic gastrointestinal carcinoid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes EMB-01?

EMB-01 is being developed by Labcorp Holdings Inc. (ticker: LH). The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced or metastatic gastrointestinal cancers.

What phase is EMB-01 in?

EMB-01 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is actively recruiting participants.

What clinical trials is EMB-01 in?

EMB-01 is being studied in a Phase 1 clinical trial with the identifier NCT05176665. The trial is titled 'EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers' and is recruiting participants in the United States and China, with a target enrollment of 152 patients.

Is EMB-01 a small molecule?

Yes, EMB-01 is a small molecule therapeutic. It is being developed as an oncology treatment and is currently in a Phase 1 clinical trial for advanced or metastatic gastrointestinal cancers.