XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint… (NCT05695898) | Clinical Trial Compass
TerminatedPhase 1
XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy
Stopped: Sponsor decision
United States6 participantsStarted 2023-02-28
Plain-language summary
This is a first-in-human, multi-center, multi-cohort, open-label, phase Ib/II study of XmAb22841 (CTLA-4 X LAG3) administered in combination with XmAb23104 (PD1 X ICOS) in participants with a histologically or cytologically confirmed diagnosis of an advanced/metastatic melanoma. XmAb22841 (CTLA-4 X LAG3) is a bi-specific antibody targeting two different T cell membrane proteins responsible for regulation of T cell activity. It offers potential immunologic and safety advantages over existing therapies. XmAb22841 (CTLA-4 X LAG3) is being evaluated in this clinical study designed to assess the safety, tolerability, PK, and PD of escalating doses of XmAb22841 (CTLA-4 X LAG3) administered in combination with XmAb23104 (PD1 X ICOS)
The study will be conducted through the University of California Melanoma Consortium (UCMC).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants must have a histologically or cytologically confirmed advanced/metastatic melanoma by pathology report. Participants with cutaneous, mucosal, acral and unknown primaries will be allowed.
✓. Participants must have progressed on either single agent programmed cell death protein 1 (PD1) or combination PD1/ cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibition therapy.
✓. Participants are allowed to have up to 4 prior lines of therapy in the metastatic setting.
✓. For Dose Escalation Phase, central nervous system (CNS) disease is not required, but it is permitted, provided the following three CNS criteria are met:
Exclusion criteria
✕. For Dose Expansion Phase:
✕. Participants must have measurable disease according to RECIST 1.1 with the following modification for brain lesions (if brain lesions are present):
✕. Age \>=18 years.
✕. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky \>60%).
What they're measuring
1
Number of Treatment- Emergent Adverse Events (Part 1)
Timeframe: Up to 24 months
2
Number of Treatment- Emergent, Immune-Related, Adverse Events (Part 1)
Timeframe: Up to 24 months
3
Number of Participants with Dose Limiting Toxicities (DLT) (Part 1)
✕. Demonstrate adequate organ function as defined below obtained within 14 days prior to the start of study treatment:
✕0. For HIV-infected participants, participants must have well controlled HIV on anti-retroviral therapy (ART), defined as:
✕1. The effects of XmAb23104 and XmAb22841 on the developing human fetus and nursing infant are unknown. Additionally, it is not known if XmAb23104 and XmAb22841 have transient adverse effects on the composition of sperm. Therefore, participants who enroll in this trial must agree to follow the below contraception requirements.
✕. has reached a postmenopausal state (\>= 12 continuous months of amenorrhea with no identified cause other than menopause)