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Bi-specific Antibody

Bi-specific Antibodies for Melanoma

Phase 1 & 2
Recruiting
Led By Adil Daud, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 must have measurable disease according to RECIST 1.1 with modifications for brain lesions.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

Study Summary

This trial will assess a new bi-specific antibody to treat advanced melanoma, to see if it is safe, tolerable, and potentially more effective than existing treatments.

Who is the study for?
Adults (18+) with advanced/metastatic melanoma who have progressed after PD1 or PD1/CTLA-4 therapy can join. They must have acceptable organ function, no severe drug-related toxicity from prior immunotherapies, and meet specific criteria if HIV-positive. Pregnant or breastfeeding individuals, those with active CNS metastases requiring high-dose steroids, uncontrolled conditions, or a history of certain severe reactions to monoclonal antibodies are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of two bi-specific antibodies: XmAb22841 (targeting CTLA-4 and LAG3) and XmAb23104 (targeting PD1 and ICOS). It's an early-phase study assessing safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in participants divided into different cohorts based on their CNS disease status.See study design
What are the potential side effects?
Potential side effects may include immune system reactions such as inflammation in various organs due to increased T cell activity. Other common side effects could involve infusion-related reactions like fever or chills; fatigue; skin issues; digestive disturbances; blood disorders; increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has worsened despite treatment with specific immune therapies.
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My cancer can be measured by scans.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Dose Limiting Toxicities (DLT) (Part 1)
Number of Treatment- Emergent Adverse Events (Part 1)
Number of Treatment- Emergent, Immune-Related, Adverse Events (Part 1)
Secondary outcome measures
Area under the curve (AUC)
CNS response rate (Cohort B Only)
Clinical Benefit Rate (CBR) (Part 2 only)
+7 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Phase 2: Dose Expansion (Cohort B)Experimental Treatment2 Interventions
Participants will stable or asymptomatic CNS disease will receive the RP2D of XmAb22841 (CTLA-4 X LAG3) in combination with 10 mg/kg of XmAb23104 (PD1 X ICOS) on days 1 & 15 of a 28 day cycles for up to 4 cycles. After Cycle 4, participants will receive 10 mg/kg of XmAb23104 (PD1 X ICOS) monotherapy up to an additional 20 cycles. Participants may receive treatments up to 24 total cycles, or until unacceptable toxicity or progressive disease; whichever comes first,
Group II: Phase 2: Dose Expansion (Cohort A)Experimental Treatment2 Interventions
Participants will no central nervous system disease (No CNS) will receive the RP2D of XmAb22841 (CTLA-4 X LAG3) in combination with 10 mg/kg of XmAb23104 (PD1 X ICOS) on days 1 & 15 of a 28 day cycles for up to 4 cycles. After Cycle 4, participants will receive 10 mg/kg of XmAb23104 (PD1 X ICOS) monotherapy up to an additional 20 cycles. Participants may receive treatments up to 24 total cycles, or until unacceptable toxicity or progressive disease; whichever comes first.
Group III: Phase 1b: Dose Escalation (Cohort 3)Experimental Treatment2 Interventions
After the safety and tolerability for cohort 2 has been evaluated, participants will receive 3 mg/kg of XmAb22841 (CTLA-4 X LAG3) in combination with 10 mg/kg of XmAb23104 (PD1 X ICOS) on days 1 & 15 of a 28 day cycles for up to 4 cycles. After Cycle 4, participants will receive 10 mg/kg of XmAb23104 (PD1 X ICOS) monotherapy up to an additional 20 cycles. Participants may receive treatments up to 24 total cycles, or until unacceptable toxicity or progressive disease; whichever comes first.
Group IV: Phase 1b: Dose Escalation (Cohort 2)Experimental Treatment2 Interventions
After the safety and tolerability for cohort 1 has been evaluated, participants will receive 1 mg/kg of XmAb22841 (CTLA-4 X LAG3) in combination with 10 mg/kg of XmAb23104 (PD1 X ICOS) on days 1 & 15 of a 28 day cycles for up to 4 cycles. After Cycle 4, participants will receive 10 mg/kg of XmAb23104 (PD1 X ICOS) monotherapy up to an additional 20 cycles. Participants may receive treatments up to 24 total cycles, or until unacceptable toxicity or progressive disease; whichever comes first.
Group V: Phase 1b: Dose Escalation (Cohort 1)Experimental Treatment2 Interventions
Participants will receive 0.3 mg/kg of XmAb22841 (CTLA-4 X LAG3) in combination with 10 mg/kg of XmAb23104 (PD1 X ICOS) on days 1 & 15 of a 28 day cycles for up to 4 cycles. After Cycle 4, participants will receive 10 mg/kg of XmAb23104 (PD1 X ICOS) monotherapy up to an additional 20 cycles. Participants may receive treatments up to 24 total cycles, or until unacceptable toxicity or progressive disease; whichever comes first.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,495 Previous Clinical Trials
11,933,123 Total Patients Enrolled
11 Trials studying Melanoma
387 Patients Enrolled for Melanoma
Xencor, Inc.Industry Sponsor
29 Previous Clinical Trials
2,747 Total Patients Enrolled
4 Trials studying Melanoma
748 Patients Enrolled for Melanoma
Adil Daud, MDPrincipal InvestigatorUniversity of California, San Francisco
6 Previous Clinical Trials
298 Total Patients Enrolled
5 Trials studying Melanoma
216 Patients Enrolled for Melanoma

Media Library

XmAb22841 (Bi-specific Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT05695898 — Phase 1 & 2
Melanoma Research Study Groups: Phase 2: Dose Expansion (Cohort A), Phase 1b: Dose Escalation (Cohort 3), Phase 2: Dose Expansion (Cohort B), Phase 1b: Dose Escalation (Cohort 1), Phase 1b: Dose Escalation (Cohort 2)
Melanoma Clinical Trial 2023: XmAb22841 Highlights & Side Effects. Trial Name: NCT05695898 — Phase 1 & 2
XmAb22841 (Bi-specific Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695898 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for participation in this investigation currently available?

"Evidenced by the clinicaltrials.gov page, this medical trial has ceased recruiting patients; its initial posting on April 1st 2023 was followed up with an edit on January 13th 2023. Despite not being presently enlisting volunteers, there are 752 other trials that require involvement from test subjects."

Answered by AI

What insights is this research endeavor attempting to uncover?

"Over the course of two years, researchers leading this clinical trial will evaluate Treatment-Emergent Immune-Related Adverse Events (Part 1) as their primary endpoint. Secondary endpoints include Area under the Curve (AUC), Mean Minimum Concentration (Cmin), and Mean Maximum Concentration (Cmax). All three metrics will be assessed by monitoring serum levels of XmAb23104 and XmAb22841 from day one through follow up visits until completion."

Answered by AI
~28 spots leftby Dec 2025