A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors
Phase 1
Recruiting
- Conditions
- Solid TumorMetastatic Solid TumorAdvanced Solid TumorImmune Sensitive Tumor
- Interventions
- Registration Number
- NCT06952010
- Lead Sponsor
- Exelixis
- Brief Summary
This is a phase 1, first-in-human, open-label, dose-escalation study of XB628, a first-in-class bispecific antibody natural killer (NK) cell engager that targets NK group 2 member A (NKG2A), an inhibitory receptor on NK cells, and programmed cell death-ligand 1 (PD-L1).
- Detailed Description
This study consists of a Dose-Escalation Stage. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]) of XB628 as a single agent.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Minimum life expectancy of ≥ 12 weeks.
- Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed.
- Adequate organ and marrow function.
- Not amenable to curative treatment with surgery or radiation.
- Received at least 1 line of prior systemic anticancer therapy in the recurrent or metastatic setting.
- Acceptable alternative therapy was received, refused, intolerable, or no longer effective.
- Capable of understanding and complying with the protocol requirements and provide signed informed consent according to the protocol and local requirements.
Exclusion Criteria
- Primary brain tumors or known active brain metastases.
- Major surgery (eg, gastrointestinal surgery, removal or biopsy of brain metastasis) within 4 weeks before the first dose of study treatment.
- Received radiation therapy within 1 week before the first dose of study treatment or clinically relevant ongoing complications from prior radiation therapy.
- Received prior therapy targeting NK cells (eg, monalizumab).
- A woman of childbearing potential has a positive serum pregnancy test within 7 days prior to study treatment.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description XB628 XB628 Group(s) of participants with recurrent advanced or metastatic solid tumors will receive escalating dose levels doses of XB628.
- Primary Outcome Measures
Name Time Method Number of Participants with Dose Limiting Toxicities (DLTs) 21 days Number of Participants with Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs), and Adverse Events (AEs) Leading to Dose Withholding, Treatment Discontinuation, or Death 27 months
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-time Curve (AUC) of XB628 25 months Maximum Plasma Concentration (Cmax) of XB628 25 months Time to Maximum Concentration (Tmax) of XB628 25 months Elimination Half-life (T1/2) of XB628 25 months Apparent Clearance (CL/F) of XB628 25 months Trough Concentration (Ctrough) of XB628 25 months Number of Participants with Antidrug Antibody (ADA) Response to XB628 25 months Objective Response Rate (ORR) 27 months Duration of Response (DOR) 27 months RDE for XB628 25 months
Trial Locations
- Locations (2)
Exelixis Clinical Site #1
🇺🇸Hickory, North Carolina, United States
Exelixis Clinical Site #2
🇺🇸San Antonio, Texas, United States