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NCT06952010
A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors
Conditions: Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor, Immune Sensitive Tumor
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 303
Sponsor: Exelixis
Location: Exelixis Clinical Site #5 San Francisco California
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.
Eligibility 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/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT06952010). StuddyBuddy aggregates publicly available trial information.