A Phase 1/2 interventional study of ALKS 4230 and Pembrolizumab in Advanced Solid Tumors, sponsored by Mural Oncology, Inc. Completed at 48 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Mural Oncology, Inc · Phase 1/2, Interventional, and Treatment
This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.
This study will evaluate ALKS 4230 administered SC as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced solid tumors.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 116 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Mural Oncology, Inc is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Administered via SC injection once every 7 days or once every 21 days at escalating doses
Biological: ALKS 4230
ALKS 4230 will be administered via SC injection once every 7 or 21 days at escalating doses or at the recommended phase 2 dose and schedule; pembrolizumab will be administered as an intravenous infusion given over 30 minutes; the dose level for pembrolizumab will be 200 mg per the approved label. In December 2020, an RP2D of 3 mg with an administration schedule of q7d was determined for SC ALKS 4230.
Biological: ALKS 4230 · Biological: Pembrolizumab
SC injection administered in the back of the arm or the abdomen
Administered as an intravenous (IV) infusion over 30 minutes
Also known as: Keytruda
Incidence of Adverse Events (AEs), and identify the RP2D of ALKS 4230 in Part A
Includes AEs that are both serious and drug-related
Time frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Number of subjects experiencing AEs that are both serious and drug-related in Part B
Includes AEs that are both serious and drug-related
Time frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Clinical Activity of combination treatment with ALKS 4230 and pembrolizumab in each Part B tumor type.
Overall Response rate (ORR) will be based on investigator review of radiographic and photographic images
Time frame: From time of therapy until the date of first documented tumor progression, assessed up to 24 months
Proportion of subjects with objective evidence of Complete Response (CR)/immune CR (iCR)
Overall response rate (ORR) will be based on investigator review of radiographic or photographic images
Time frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Proportion of subjects with objective evidence of Partial Response (PR)/immune PR (iPR)
ORR will be based on investigator review of radiographic or photographic images
Time frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Duration of response in subjects with CR/iCR
CR/iCR duration
Time frame: Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
Duration of response in subjects with PR/iPR
PR/iPR duration
Time frame: Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
Non-progression for Part B
Time from first dose of SC ALKS 4230 to the time of progression or death
Time frame: Assessed up to 24 months
Overall survival for Part B
Time from first dose of SC ALKS 4230 to the time of death
Time frame: Assessed up to 24 months
Serum concentrations of ALKS 4230 will be determined at various time points
Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level
Time frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Serum will be assayed for the presence of anti-ALKS 4230 antibodies
Results will be summarized by dose level
Time frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
Results will be summarized by dose level
Time frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Serum concentrations of proinflammatory cytokines will be assessed using a multiplex method at various time points
Results will be summarized by dose level
Time frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Plan to share: No — At this time, IPD sharing has not been defined and/or decided if it will be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Mural Oncology, Inc