Health Trials

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

ConditionRelapsed/Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

The purpose of this study is to assess the safety, tolerability, and efficacy of sonrotoclax as monotherapy and in various combinations in patients with relapsed/refractory (R/R) multiple myeloma (MM) and chromosomal translocation t(11;14).

The study investigates sonrotoclax alone and in combination with dexamethasone and other agents, including carfilzomib, daratumumab, and pomalidomide.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)

Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.

In Part 1 and Part 2 Cohorts 1 and 2 participants should have relapsed or progressive disease and have had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody, and no more available approved therapies.

Disqualifiers

Non secretory MM (Serum free light chains < 10 mg/dL)

Solitary plasmacytoma

Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or > 2.0 x 109/L circulating plasma cells by standard differential)

Waldenström macroglobulinemia (WM)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sonrotoclax

    Drug

    Administered orally daily

  • Dexamethasone

    Drug

    Once weekly either orally or intravenously

  • Carfilzomib

    Drug

    Administered intravenously weekly

  • Daratumumab

    Drug

    Administered subcutaneously weekly

  • Pomalidomide

    Drug

    Administered orally daily

Treatment groups

246 Participants
are divided into 2 treatment groups
Group A: Part 1 Dose EscalationExperimental treatment 5 interventions
Group B: Part 2 Cohort ExpansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)

DLTs will be based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and will include most grade 3 or higher events, as defined in the protocol.

Time frame
Up to 28 days
2

Part 1 And 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation and Adverse Events of Special Interest (AESIs).

Time frame
Up to 30 days after last dose of study drug
3

Part 2: Overall response rate (ORR) as Assessed by Investigator

Defined as the percentage of participants who achieved a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per International Myeloma Working Group (IMWG) criteria

Time frame
Approximately 4 years
4

Part 2: Very Good Partial Response (VGPR) or Better Response Rate as Assessed by Investigator

Defined as the percentage of participants with a documented VGPR or better (including sCR, CR, and VGPR)

Time frame
Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years]

Secondary outcomes

1

Part 1: Area under the plasma concentration-time curve time 0 to the last measurable concentration (AUClast) After a Single Dose of Sonrotoclax

Time frame
Cycle 1 (each cycle is up to 28 days)
2

Part 1: Maximum observed plasma concentration (Cmax) After a Single Dose of Sonrotoclax

Time frame
Cycle 1 (each cycle is up to 28 days)
3

Part 1: Time to reach Cmax (tmax) After a Single Dose of Sonrotoclax

Time frame
Cycle 1 (each cycle is up to 28 days)
4

Part 1: At Steady-state: AUC last, ss

Time frame
Cycle 2 (each cycle is up to 28 days)

Other outcomes

Sponsors and contacts

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

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov
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