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A Phase I Study of SHR-3836 in Patients With Multiple Myeloma

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-3836 in patients with multiple myeloma (MM).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, male or female

Expected survival ≥ 3 months

ECOG performance status 0 or 1

Diagnosed with active multiple myeloma per IMWG criteria

Disqualifiers

Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome.

Central nervous system involvement by tumor.

History of ≥ Grade 3 CRS with prior T-cell redirecting therapy.

Requirement for dialysis or plasmapheresis within 14 days prior to study drug.

Trial design

Design model

Sequential

Treatments tested in this trial

  • SHR-3836 administered as multiple doses.

    Drug

    * In the dose escalation phase, doses are escalated sequentially from low to high levels. * In the dose expansion phase, one or more selected dose levels are further evaluated.

Treatment groups

99 Participants
are divided into 1 treatment group
Group A: SHR-3836 for injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determination of Phase II Dose (RP2D) of SHR-3836

Time frame
24 months

Secondary outcomes

1

Incidence and severity of adverse events (AE) of SHR-3836

Time frame
24 months
2

Maximum plasma concentration (Cmax)

Time frame
24 months
3

Time to reach Cmax (Tmax)

Time frame
24 months
4

Objective response rate (ORR)

Time frame
24 months

Other outcomes

Sponsors and contacts

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

Shanghai Hengrui Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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