TerminatedPhase 1/2

A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma

Stopped: Company's resource optimization and product's development change

Australia, China40 participantsStarted 2021-05-20

Plain-language summary

The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-06 and to characterize the safety and tolerability of EMB-06 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-06 will also be assessed.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Treated with monoclonal antibody for multiple myeloma within 28 days
✕. Treated with proteasome inhibitors within 14 days
✕. Treated with immunomodulatory agents within 14 days
✕. Treated with cytotoxic therapy within 14 days
✕. Received investigational drug within 28 days or at least 5 half-lives, whichever is shorter (if a, b, c, d not applicable)
✕. Received radiotherapy within 21 days. Except that the radiation portal covered ≤ 5% of the bone marrow reserve, the patient will be eligible to participate in the study regardless of the end date of radiation therapy
✕. Plasmapheresis within 7 days

What they're measuring

Incidence and severity of adverse events

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

Incidence of serious adverse events (SAE)

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

Incidence of dose interruptions.

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

Dose intensity

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

The incidence of DLTs during treatment.

Timeframe: First infusion to the end of Cycle 1 (each cycle is 28 days)

Overall Response Rate (ORR)

Timeframe: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months

Trial details

NCT IDNCT04735575

SponsorShanghai EpimAb Biotherapeutics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-20

View on ClinicalTrials.gov More Relapsed or Refractory Multiple Myeloma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Treated with monoclonal antibody for multiple myeloma within 28 days
✕. Treated with proteasome inhibitors within 14 days
✕. Treated with immunomodulatory agents within 14 days
✕. Treated with cytotoxic therapy within 14 days
✕. Received investigational drug within 28 days or at least 5 half-lives, whichever is shorter (if a, b, c, d not applicable)
✕. Received radiotherapy within 21 days. Except that the radiation portal covered ≤ 5% of the bone marrow reserve, the patient will be eligible to participate in the study regardless of the end date of radiation therapy
✕. Plasmapheresis within 7 days

What they're measuring

Incidence and severity of adverse events

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

Incidence of serious adverse events (SAE)

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

Incidence of dose interruptions.

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

Dose intensity

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

The incidence of DLTs during treatment.

Timeframe: First infusion to the end of Cycle 1 (each cycle is 28 days)

Overall Response Rate (ORR)

Timeframe: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months