Health TrialsbyHealthPanel

Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients

ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai EpimAb Biotherapeutics Co., Ltd.

About this trial

This study is testing different dosing schedules of EMB-01 in patients with advanced colorectal cancer whose disease has recurrent or progressed on previous treatments. Patients will be randomly assigned to one of two dosing schedules: EMB-01 once weekly, or once weekly for 6 weeks then every two weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to understand and willing to sign the informed consent form (ICF).

Male or female aged ≥ 18 years.

Histologically or cytologically confirmed unresectable or metastatic left-sided colorectal cancer (primary tumor from splenic flexure to rectum) with at least one measurable lesion according to RECIST v1.1.

ECOG performance status ≤ 1.

Disqualifiers

Presence of KRAS/NRAS exon 2, 3, 4 mutations, BRAF V600 mutation, HER2 positivity (IHC3+ or amplification), RET fusion, NTRK fusion, or other molecular mutations affecting anti-EGFR or cMET efficacy(Investigator and sponsor discussion recommended if applicable), based on central lab testing or prior treatment history.

Life expectancy < 3 months.

Residual adverse events (AEs) from prior anti-cancer therapy > CTCAE grade 1.

Primary CNS malignancy or symptomatic CNS metastases (brain, leptomeningeal, or arachnoid). Patients with asymptomatic CNS metastases may be eligible if no local radiotherapy is needed, or radiotherapy was completed ≥ 4 weeks prior to study treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EMB-01 1600 mg administered once weekly throughout the study

    Drug

    Participants receive EMB-01 at a dose of 1600 mg administered once weekly (QW) throughout the study.

  • EMB-01 1600 mg once weekly for 6 weeks, then every 2 weeks thereafter

    Drug

    Participants receive EMB-01 at a dose of 1600 mg administered once weekly (QW) for the first 6 weeks, followed by 1600 mg administered every 2 weeks (Q2W) thereafter.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: EMB-01 1600 mg once weekly (QW)Experimental treatment 1 intervention
Group B: EMB-01 1600 mg once weekly (QW) for 6 weeks, then 1600 mg every 2 weeks (Q2W)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate

Objective response rate of EMB-01 at different dose levels

Time frame
Drom 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
2

Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0

Number of participants with Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0

Time frame
Screening up to follow-up (30 days after the last dose)

Secondary outcomes

1

Best Overall Response (BOR) as assessed by RECIST v1.1

Best Overall Response (BOR) as assessed by RECIST v1.1

Time frame
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
2

Cmax

PK parameter Cmax of EMB-01 at different dose levels

Time frame
Up to 3 months after first study drug administration
3

ADA

Incidence of anti-drug antibodies (ADA) of EMB-01 at different dose levels

Time frame
Up to the 30-day safety follow-up visit after EOT
4

Ctrough

Measured trough concentration (Ctrough) of EMB-01

Time frame
Through treatment completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai EpimAb Biotherapeutics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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