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A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors

ConditionsSolid TumorAdvanced Solid TumorMetastatic Solid TumorImmune Sensitive Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorExelixis

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • XB628

    Biological/Vaccine

    Intravenous infusion(s)

  • Zanzalintinib

    Drug

    Oral tablet(s)

Treatment groups

303 Participants
are divided into 2 treatment groups
Group A: Dose Escalation PhaseExperimental treatment 2 interventions
Group B: Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs)

Time frame
21 days
2

Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame
Up to 27 months
3

Dose Expansion Cohort: Objective Response Rate (ORR)

Time frame
Up to 27 months

Secondary outcomes

1

Area Under the Concentration-time Curve (AUC) of XB628

Time frame
25 months
2

Maximum Plasma Concentration (Cmax) of XB628

Time frame
25 months
3

Time to Maximum Concentration (Tmax) of XB628

Time frame
25 months
4

Elimination Half-life (T1/2) of XB628

Time frame
25 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Exelixis

Lead sponsor

Source ClinicalTrials.gov
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