A Phase 1/2 Open-label, Multicentre, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Clinical Activity of Belantamab as Monotherapy and in Combination With Other Treatments in Participants With Multiple Myeloma

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The study consists of two parts: Part 1 The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent belantamab in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). Part 2 The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different dose ratios of belantamab mafodotin in combination with belantamab (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction in which the study is taking place.

• Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the international myeloma working group (IMWG).

• 1\. Participants who have received at least 3 prior lines of anti-myeloma treatments, and have already received an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 mAb (unless contraindicated or unavailable) and have confirmed progression on or following the last line of treatment.

• Participants with a history of Autologous stem cell transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:

‣ transplant was greater than (\>)100 days prior to screening.

⁃ no active infection(s)

• Eastern cooperative oncology group-performance status (ECOG-PS) of 0 to 2.

• Measurable disease defined as at least ONE of the following:

‣ Serum M-protein concentration greater than (\>=) 0.5 gram (g)/ deciliter (dL) (\>=5 gram/liter \[g/L\])

⁃ Urine M-protein excretion \>=200 mg/24 hours (\>=0.2 g/24 hours)

⁃ Serum free light chain (FLC) assay: involved FLC level \>=10 mg/dL (\>=100 milligrams per liter \[mg/L\]) and an abnormal serum FLC ratio (less than \[\<\]0.26 or \>1.65)

• Have adequate organ system function as defined by the laboratory assessments.

• All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\], v5.0, 2017) must be Grade \<=1 at the time of screening except for alopecia (any grade), neuropathy (Grade \<=2), or endocrinopathy managed with replacement therapy (any grade).

• Participants or Legally authorized representative (LAR) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Locations
United States
Michigan
GSK Investigational Site
RECRUITING
Grand Rapids
Other Locations
Argentina
GSK Investigational Site
COMPLETED
Ciudadela
GSK Investigational Site
RECRUITING
Viedma
Australia
GSK Investigational Site
RECRUITING
Fitzroy
GSK Investigational Site
COMPLETED
Nedlands
Brazil
GSK Investigational Site
RECRUITING
Joinville
GSK Investigational Site
RECRUITING
Salvador
GSK Investigational Site
RECRUITING
São Paulo
Japan
GSK Investigational Site
RECRUITING
Aomori
GSK Investigational Site
RECRUITING
Chiba
GSK Investigational Site
COMPLETED
Osaka
GSK Investigational Site
RECRUITING
Tokyo
Poland
GSK Investigational Site
WITHDRAWN
Gdansk
GSK Investigational Site
RECRUITING
Lublin
Republic of Korea
GSK Investigational Site
RECRUITING
Seoul
GSK Investigational Site
RECRUITING
Seoul
Taiwan
GSK Investigational Site
RECRUITING
Changhua
GSK Investigational Site
RECRUITING
Taipei
United Kingdom
GSK Investigational Site
RECRUITING
Leicester
GSK Investigational Site
RECRUITING
Oxford
GSK Investigational Site
RECRUITING
Plymouth
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2023-06-14
Estimated Completion Date: 2029-12-03
Participants
Target number of participants: 55
Treatments
Experimental: Part 1: Dose escalation of belantamab monotherapy
Belantamab will be administered in participants with RRMM until progressive disease (PD)
Experimental: Part 2: Belantamab and belantamab mafodotin (delivered as separate drugs) dose range finding
Participants with RRMM will receive belantamab in combination with a fixed dose of belantamab mafodotin (delivered as separate drugs)
Experimental: Part 1b: Optional belantamab mafodotin
Participants enrolled in Part 1 and Part 2 will be dosed until PD after which they will have the option to receive treatment with single agent belantamab mafodotin.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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