First in Human Study of M6223 (NCT04457778) | Clinical Trial Compass
CompletedPhase 1
First in Human Study of M6223
United States, Canada58 participantsStarted 2020-07-10
Plain-language summary
The main purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), immunogenicity and (if observed) the maximum tolerated dose (MTD) of M6223 as a single agent (Part 1A) for both the every 2 weeks (Q2W) regimen and the every 3 weeks (Q3W) regimen and of M6223 combined with bintrafusp alfa (Part 1B) for Q2W regimen in participants with metastatic or locally advanced solid unresectable tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants have histologically or cytologically proven locally advanced or advanced solid malignancies who are refractory to or have progressed under standard treatment and have no other treatment options known to confer clinical benefit
* Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at Screening
* Participant has a formalin-fixed paraffin-embedded block containing tumor tissue or a minimum of 15 (preferably 25) unstained tumor slides suitable for immunohistochemistry-based staining of protein expression
* Participants with life expectancy of at least 12 weeks
* Participants with measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
* Adequate hematological, hepatic and renal function as defined in the protocol
* Other protocol defined inclusion criteria may apply
Exclusion Criteria:
* Participants with persisting toxicity related to prior therapy Grade greater than (\>) 1 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, however, alopecia, sensory neuropathy Grade less than or equal to (\<=) 2, or other non-immune-related Grade \<= 2 not constituting a safety risk
* Participants with prior organ transplantation including allogeneic stem cell transplantation
* Participants with prior toxicity related to an immune checkpoint inhibitor Grade greater than equal to (\>=) 3 NCI-CTCAE Version 5.0 unless resolved to…
What they're measuring
1
Part 1A and 1B: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) Assessed Using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0
Timeframe: Day 1 to Day 28
2
Part 1A and 1B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs
Timeframe: Approximately 2 years 11 months
3
Part 1A and 1B: Number of Participants With TEAES With Severity of Grade Greater or Equal to 3 and TEAEs Leading to Deaths
Timeframe: Approximately 2 years 11 months
4
Part 1A and 1B: Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values
Timeframe: Approximately 2 years 11 months
5
Part 1A and 1B: Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)
Timeframe: Approximately 2 years 11 months
6
Part 1A and 1B: Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs
Timeframe: Approximately 2 years 11 months
7
Part 1A and 1B: Number of Participants With Worsened Post Baseline Shift in Eastern Cooperative Oncology Group Performance Status
Trial details
NCT IDNCT04457778
SponsorEMD Serono Research & Development Institute, Inc.