Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05695898
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2023-01-13
Brief Title:
XmAb23104 PD1 X ICOS and XmAb22841 CTLA-4 X LAG3 in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Phase IbII Study of XmAb23104 PD1 X ICOS and XmAb22841 CTLA-4 X LAG3 Combination in Metastatic Melanoma Refractory to Prior Immune Checkpoint Inhibitor Therapy With and Without CNS Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a first-in-human multi-center multi-cohort open-label phase IbII 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 advancedmetastatic 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
The study will be conducted through the University of California Melanoma Consortium UCMC
Detailed Description:
PRIMARY OBJECTIVES
I Dose Escalation Phase Part 1 To estimate the recommended phase 2 dose RP2D of XmAb22841 CTLA-4 X LAG3 in combination XmAb23104 PD1 X ICOS
II Dose Expansion Phase Part 2 To assess clinical response as measured by objective response rate of patients treated with XmAb22841 CTLA-4 X LAG3 in combination XmAb23104 PD1 X ICOS
SECONDARY OBJECTIVES
I To evaluate the pharmacokinetics PK and anti-drug antibody ADA immunogenicity of XmAb23104 PD1 X ICOS and XmAb22841 CTLA-4 X LAG3 Dose Escalation Part 1 Dose Expansion Part 2
II To evaluate the clinical efficacy of XmAb23104 PD1 X ICOS and XmAb22841 CTLA-4 X LAG3 Dose Expansion Part 2
EXPLORATORY OBJECTIVES
I To identify molecular genomic metabolic andor proteomic biomarkers that may be indicative of clinical responseresistance safety pharmacodynamic activity andor the mechanism of action of XmAb22841 CTLA-4 X LAG3 administered in combination with XmAb23104 PD1 X ICOS Dose Escalation Part 1 Dose ExpansionPart 2
OUTLINE
Participants will initially be enrolled in the Dose Escalation Phase Part 1
PHASE 2 Dose Expansion Part 2 will not be initiated
Participants may continue trial therapy until the earlier of radiographic disease progression withdrawal unacceptable toxicity completion of 24 cycles of XmAb23104 PD1 X ICOS or other treatment discontinuation due to unacceptable toxicity participant withdrawal progressive disease or death The entire treatment duration of twenty-four 28-day cycles is approximately 2 years After discontinuing trial therapy participants will be followed for toxicity response and overall survival every 12 weeks for up to 5 years from initiation of study treatment
I Dose Escalation Phase Part 1 To estimate the recommended phase 2 dose RP2D of XmAb22841 CTLA-4 X LAG3 in combination XmAb23104 PD1 X ICOS
II Dose Expansion Phase Part 2 To assess clinical response as measured by objective response rate of patients treated with XmAb22841 CTLA-4 X LAG3 in combination XmAb23104 PD1 X ICOS
SECONDARY OBJECTIVES
I To evaluate the pharmacokinetics PK and anti-drug antibody ADA immunogenicity of XmAb23104 PD1 X ICOS and XmAb22841 CTLA-4 X LAG3 Dose Escalation Part 1 Dose Expansion Part 2
II To evaluate the clinical efficacy of XmAb23104 PD1 X ICOS and XmAb22841 CTLA-4 X LAG3 Dose Expansion Part 2
EXPLORATORY OBJECTIVES
I To identify molecular genomic metabolic andor proteomic biomarkers that may be indicative of clinical responseresistance safety pharmacodynamic activity andor the mechanism of action of XmAb22841 CTLA-4 X LAG3 administered in combination with XmAb23104 PD1 X ICOS Dose Escalation Part 1 Dose ExpansionPart 2
OUTLINE
Participants will initially be enrolled in the Dose Escalation Phase Part 1
PHASE 2 Dose Expansion Part 2 will not be initiated
Participants may continue trial therapy until the earlier of radiographic disease progression withdrawal unacceptable toxicity completion of 24 cycles of XmAb23104 PD1 X ICOS or other treatment discontinuation due to unacceptable toxicity participant withdrawal progressive disease or death The entire treatment duration of twenty-four 28-day cycles is approximately 2 years After discontinuing trial therapy participants will be followed for toxicity response and overall survival every 12 weeks for up to 5 years from initiation of study treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-00868 | REGISTRY | NCI Clinical Trials Reporting Program CTRP | None |