UnknownPhase 1/2

A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors

United States, China186 participantsStarted 2018-12-13

Plain-language summary

First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients with Advanced/Metastatic Solid Tumors

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. The patient must sign the molecular pre-screening Inform Consent to allow for the molecular pre-screening process. All patients must have documented evidence of EGFR and/or cMet aberrations.
✓. Able to understand and willing to sign the Informed Consent Form (ICF).
✓. Histologically/cytologically confirmed advanced/metastatic solid tumors with measurable disease \[Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\]:
✓. Must have adequate organ function.
✓. Regarding prior anti-tumor therapy:
✓. Must have stopped treatment at least 4 weeks or within 5 half-lives.
✓. Generalized radiation therapy must have stopped 3 weeks before first dose of EMB 01, or local radiotherapy or radiation therapy for bone metastases must have stopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken within 8 weeks before first dose of EMB-01.
✓. Patients must have recovered to ≤Grade 1 from the adverse effects of such above treatment before beginning study treatment.

Exclusion criteria

✕. Patients who are unwilling to sign the molecular pre-screening ICF.
✕. Patients for whom local EGFR and/or cMET data or the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.
✕. Life expectancy \< 3 months.
✕. Subject with primacy central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases.
✕. Pregnant or nursing females.
✕. Subjects who have had major surgery within 28 days prior to screening.
✕. Serious underlying medical conditions, including but not limited to un-controlled hypertension, other cardiovascular disease or diabetes, ongoing or active infection, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere the compliance with study treatment.

What they're measuring

Maximum tolerated dose (MTD) (phase 1 only)

Timeframe: cycle 1 (1cycle = 28 days)

Adverse Events (AEs), and Serious Adverse Events (SAEs)

Timeframe: Screening up to follow-up (30 days after the last dose)

Overall Response Rate (ORR) (phase 2 only)

Timeframe: From the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Trial details

NCT IDNCT03797391

SponsorShanghai EpimAb Biotherapeutics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-14

Contact for this trial

Xiaodong Sun, MD

+86-21-61043299 xdsun@epimab.com

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