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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 (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The study consists of three parts: * Part 1 The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent Unconjugated belantamab antibody 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 Unconjugated belantamab antibody (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+). * Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the unconjugated belantamab antibody, either alone or in combination with belantamab mafodotin alongside the standard of care (SoC) pomalidomide-dexamethasone backbone. The study will focus on patients with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.

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) and have progressed on or following the last line of treatment Part 1 and Part 2: Participants who have received at least 3 prior lines of anti-myeloma treatments, , including lenalidomide, a proteasome inhibitor, and an anti-CD38 mAb either in combination or separately.

• Part 3: Have received at least 1 prior line of treatment anti-myeloma treatments, including lenalidomide. Prior anti-CD38-containing regimen is not mandated, however no more than 70% of participants recruited may be anti-CD38 naïve

• 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 bacterial, viral, or fungal infection(s) present

• 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 milligram(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.

• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

• Is NOT a Participant of child-bearing potential (POCBP) or

• Is a POCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency during the intervention period and for 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.

• Part 3: Due to pomalidomide being a thalidomide analogue with a risk for embryofetal toxicity and prescribed under a pregnancy prevention/controlled distribution programme, POCBP will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or use two methods of reliable birth control (one method that is highly effective plus an additional barrier method), beginning at least 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions and continuing for at least 4 weeks following discontinuation of pomalidomide treatment. Thereafter, POCBP must use one contraceptive method that is highly effective (with a failure rate of less than (\<)1 percentage (%) per year) for a further 3 months (total 4 months).

• The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention

• All POCBP must agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period

Locations
United States
Michigan
GSK Investigational Site
RECRUITING
Grand Rapids
North Carolina
GSK Investigational Site
RECRUITING
Chapel Hill
Tennessee
GSK Investigational Site
RECRUITING
Chattanooga
GSK Investigational Site
RECRUITING
Nashville
Other Locations
Argentina
GSK Investigational Site
COMPLETED
Ciudadela
GSK Investigational Site
RECRUITING
San Juan Bautista
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
Turkey
GSK Investigational Site
RECRUITING
Istanbul
GSK Investigational Site
RECRUITING
Kayseri
United Kingdom
GSK Investigational Site
RECRUITING
Leicester
GSK Investigational Site
COMPLETED
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: 153
Treatments
Experimental: Part 1: Dose escalation and expansion of the unconjugated belantamab antibody monotherapy
Unconjugated belantamab antibody will be administered in participants with RRMM until progressive disease (PD)
Experimental: Part 2:Unconjugated belantamab antibody and belantamab mafodotin-given separately dose range finding
Participants with RRMM will receive unconjugated belantamab antibody and belantamab mafodotin
Experimental: Part 3: Unconjugated belantamab +/- belantamab mafodotin +pomalidomide/dexamethasone in 2L+ RRMM
Participants with second line (2L+) RRMM will receive Unconjugated belantamab antibody in combination with pomalidomide-dexamethasone backbone, with or without belantamab mafodotin.
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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