A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors
- 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.
- Short title
- A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors
- Official title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-11-30
- First posted
- 2025-04-30
- Registry last updated
- 2026-06-24
- Primary completion date
- 2027-05-31
- Start date
- 2025-05-01
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Exelixis
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06952010
- ClinicalTrials.gov ID
- NCT06952010
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs)
Timeframe: 21 days
Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to 27 months
Dose Expansion Cohort: Objective Response Rate (ORR)
Timeframe: Up to 27 months
Area Under the Concentration-time Curve (AUC) of XB628
Timeframe: 25 months
Maximum Plasma Concentration (Cmax) of XB628
Timeframe: 25 months
Time to Maximum Concentration (Tmax) of XB628
Timeframe: 25 months
Elimination Half-life (T1/2) of XB628
Timeframe: 25 months
Apparent Clearance (CL/F) of XB628
Timeframe: 25 months
Trough Concentration (Ctrough) of XB628
Timeframe: 25 months
Number of Participants with Antidrug Antibody (ADA) Response to XB628
Timeframe: 25 months
RDE for XB628
Timeframe: 25 months
Dose Expansion Cohort: Duration of Response (DOR)
Timeframe: 27 months
Dose Expansion Cohort: Progression-Free Survival (PFS) of XB628
Timeframe: 27 months
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
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/Exclusion criteria may apply.
- Exelixis Clinical Site #5San Francisco, United StatesRecruiting
- Exelixis Clinical Site #4New Haven, United StatesRecruiting
- Exelixis Clinical Site #8Tampa, United StatesRecruiting
- Exelixis Clinical Site #10Boston, United StatesRecruiting
- Exelixis Clinical Site #11Boston, United StatesRecruiting
- Exelixis Clinical Site #6St Louis, United StatesRecruiting
- Exelixis Clinical Site #7New York, United StatesRecruiting
- Exelixis Clinical Site #1Hickory, United StatesRecruiting
- Exelixis Clinical Site #3Nashville, United StatesRecruiting
- Exelixis Clinical Site #9Houston, United StatesRecruiting
- Exelixis Clinical Site #2San Antonio, United StatesRecruiting