A Phase 1 Dose Escalation and Expansion Study of XB628 as a Single Agent and in Combination With Zanzalintinib in Participants With Advanced or Metastatic Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Exelixis
- Enrollment
- 303
- Locations
- 17
- Primary Endpoint
- Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •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.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Dose Expansion
Participants with recurrent advanced or metastatic solid tumors will receive XB628 as a single agent and in combination with zanzalintinib.
Intervention: Zanzalintinib (Drug)
Dose Expansion
Participants with recurrent advanced or metastatic solid tumors will receive XB628 as a single agent and in combination with zanzalintinib.
Intervention: XB628 (Biological)
Dose Escalation Phase
Participants with recurrent advanced or metastatic solid tumors will receive escalating dose levels doses of XB628 as a single agent and in combination with zanzalintinib.
Intervention: XB628 (Biological)
Dose Escalation Phase
Participants with recurrent advanced or metastatic solid tumors will receive escalating dose levels doses of XB628 as a single agent and in combination with zanzalintinib.
Intervention: Zanzalintinib (Drug)
Outcomes
Primary Outcomes
Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 27 months
Dose Expansion Cohort: Objective Response Rate (ORR)
Time Frame: Up to 27 months
Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame: 21 days
Secondary Outcomes
- Trough Concentration (Ctrough) of XB628(25 months)
- 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)
- 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)