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Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM

A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5. Sub-study 1 - Belantamab Mafodotin and aOX40 (GSK3174998) in Combination

NCT06160609•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with other anti-cancer treatments (in each sub-study), and to establish the recommended Phase 2 dose for each combination treatment to explore in the cohort expansion phase. This study is the sub study of the Master protocol (NCT04126200).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must be 18 years of age inclusive or older, at the time of signing the informed consent.
•Participants must have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG.
•Participants having at least 3 prior lines of prior anti-myeloma treatments including an immunomodulating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
•Participants with a history of autologous stem cell transplant are eligible for study participation when, transplant was \>100 days prior to study enrolment and with no active infection(s).
•Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, unless ECOG less than equal to (\<=)2 is due solely to skeletal complications and/or skeletal pain due to MM.
•Participants with measurable disease defined as at least one of the following: Serum M-protein greater than equal to (\>=)0.5 gram per deciliter (\>=5 gram per liter) or Urine M-protein \>=200 milligrams (mg) per 24 hours or Serum free light chain (FLC) assay: Involved FLC level \>=10 mg per deciliter (\>=100 mg per Liter) and an abnormal serum FLC ratio (\<0.26 or \>1.65).
•Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B surface antigen (HBsAg)-; HBV deoxyribonucleic acid (DNA) undetectable during screening.
•Participants who are currently receiving physiological doses oral steroids (\<10 mg/day), inhaled steroids or ophthalmological steroids.

Exclusion Criteria

•Participants with current corneal epithelial disease except mild punctate keratopathy.
•Participants with evidence of cardiovascular risk.
•Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other mAb.
•Participants with active infection requiring antibiotic, antiviral, or antifungal treatment.
•Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within \<14 days.
•Participants with prior radiotherapy within 2 weeks of start of study therapy.
•Participants with prior allogeneic transplant are prohibited.
•Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
•Participants with any major surgery (other than bone-stabilizing surgery) within the last 30 days.
•Participants with prior treatment with an investigational agent within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter.
+7 more criteria

Locations (3)

GSK Investigational Site

Fitzroy, Victoria, Australia

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Stockholm, Sweden

Key Dates

Start Date

October 7, 2019

Primary Completion Date

January 9, 2023

Completion Date

January 9, 2023

Last Updated

March 12, 2024

Enrollment

ACTUAL participants

Conditions

Relapsed/Refractory Multiple Myeloma

Interventions

Belantamab Mafodotin

DRUG

GSK3174998

DRUG

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

NCT04973605

Relapsed/Refractory Multiple Myeloma

View study

RECRUITINGPHASE1

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

NCT05862012

Relapsed/Refractory Multiple Myeloma

View study

RECRUITINGPHASE2

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM

Inclusion Criteria

Exclusion Criteria

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

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials

Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma

A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients