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EMB-01 in Combination With Chemotherapy for Unresectable or Metastatic Colorectal Cancer

ConditionUnresectable/Metastatic Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-74
SponsorShanghai EpimAb Biotherapeutics Co., Ltd.

About this trial

This is an open-label, multicenter, Phase Ib trial designed to evaluate the safety, tolerability, and preliminary efficacy of EMB-01 in combination with chemotherapy in patients with unresectable or metastatic colorectal cancer (CRC), and to determine the recommended Phase II combination dose (RP2CD). The study consists of a dose escalation phase followed by a dose expansion phase. Approximately 30 patients are planned to be enrolled in each combination treatment group across both phases, with a maximum total enrollment of approximately 120 patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Male or female patients aged ≥ 18 and < 75 years. 2. Histologically or cytologically confirmed unresectable or metastatic left-sided colorectal cancer (primary tumor located from the splenic flexure to the rectum), with measurable disease per RECIST v1.1.

Patients who received any approved or investigational anti-cancer therapy must have discontinued such therapy at least 4 weeks prior to the first dose of study treatment or 5 half-lives of the agent, whichever is shorter.

Patients who received local radiotherapy, bone metastasis radiotherapy, or oral fluoropyrimidines must have discontinued such therapy at least 2 weeks prior to the first dose of study treatment. No therapeutic radiopharmaceuticals within 8 weeks prior to the first dose of EMB-01.

Arm A (irinotecan) and Arm B (TAS-102): Prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, plus prior anti-VEGF therapy (with or without anti-EGFR therapy), with disease progression or intolerance; no prior TAS-102/fruquintinib/regorafenib. If prior anti-EGFR therapy was received, the patient must have achieved CR, PR, or SD, with the last anti-EGFR dose administered at least 4 months prior to the first study drug dose.

Disqualifiers

1. Expected survival < 3 months. 2. Presence of KRAS/NRAS (exons 2, 3, 4), BRAF V600, HER2 positivity (IHC3+ and/or amplification), RET/NTRK fusion, or other molecular alterations that may affect anti-EGFR or cMET therapy efficacy, as detected by central laboratory testing at screening or documented in prior treatment history. (Discussion between investigator and sponsor in writing is recommended if applicable.) 3. Persistent adverse events (AEs) from prior anti-tumor therapy > Grade 2 per CTCAE v5.0, except alopecia, Grade 2 fatigue, or Grade 2 peripheral neuropathy.

Trial design

Design model

Sequential

Treatments tested in this trial

  • EMB-01

    Drug

    EMB-01 is a bispecific antibody against epidermal growth factor receptor (EGFR) and the receptor tyrosine kinase Met (cMET).

  • Irinotecan

    Drug

    Irinotecan will be administered as intravenous infusion.

  • TAS-102

    Drug

    TAS-102 will be administered orally.

  • mFOLFOX6

    Drug

    mFOLFOX6 will be administered as intravenous infusion.

  • FOLFIRI

    Drug

    FOLFIRI will be administered as intravenous infusion.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Arm AExperimental treatment 2 interventions
Group B: Arm BExperimental treatment 2 interventions
Group C: Arm CExperimental treatment 2 interventions
Group D: Arm DExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs)

Safety profile of EMB-01 in combination with chemotherapy will be evaluated by the incidence, severity, seriousness, and relationship of AEs, graded per CTCAE v5.0

Time frame
From enrollment up to 30 days after last dose of study treatment
2

Incidence of dose-limiting toxicities (DLTs)

DLTs will be assessed according to protocol-defined criteria during the first treatment cycle of EMB-01 in combination with chemotherapy regimens

Time frame
Up to Cycle 1 (28 days)
3

Tolerability of EMB-01 in combination with chemotherapy

Outcome Measure: Treatment interruption due to intolerability and relative dose intensity (RDI)

Time frame
From first dose to 30 days after last dose, up to 2 years
4

Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2CD)

Determination of the MTD and/or RP2CD of EMB-01 in combination with chemotherapy

Time frame
Through study completion, up to 2 years

Secondary outcomes

1

Cmax

Time frame
Predose, 0, 0.25, 1.5, 24, 48, 72hours post-dose
2

Ctrough

Time frame
Predose, 0, 0.25, 1.5, 24, 48, 72hours post-dose
3

Objective response rate (ORR)

defined as the proportion of participants achieving CR or PR per RECIST v1.1

Time frame
From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years.
4

Disease control rate (DCR)

defined as the proportion of participants achieving CR, PR, or SD per RECIST v1.1

Time frame
From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Shanghai EpimAb Biotherapeutics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: