Advanced Solid Tumor, Immune Sensitive Tumor, Metastatic Solid Tumor, Solid Tumor
Conditions
Keywords
XB628, Solid tumor, Advanced solid tumor, Metastatic solid tumor, Immune sensitive tumor, PD-L1, Zanzalintinib
Brief summary
This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]); and the dose expansion stage is to evaluate the preliminary antitumor activity of XB628 as a single agent and in combination with zanzalintinib.
Interventions
BIOLOGICALXB628
Intravenous infusion(s)
DRUGZanzalintinib
Oral tablet(s)
Sponsors
Exelixis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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. Key
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. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs) | 21 days |
| Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 27 months |
| Dose Expansion Cohort: Objective Response Rate (ORR) | Up to 27 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| RDE for XB628 | 25 months |
| Dose Expansion Cohort: Duration of Response (DOR) | 27 months |
| Dose Expansion Cohort: Progression-Free Survival (PFS) of XB628 | 27 months |
Countries
United States
Contacts
CONTACTExelixis Clinical Trials
CONTACTBackup or International
STUDY_DIRECTORMedical Director
Exelixis
Outcome results
None listed