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A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorExelixis

About this trial

This is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as pharmacokinetics (PK) and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in participants with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capable of understanding and complying with protocol requirements.

Male or female aged 18 years or older.

Eastern Cooperative Oncology Group performance status 0 or 1.

Adequate bone marrow and organ function.

Disqualifiers

Small molecule-targeted therapy < 5 half-lives from first dose of study treatment, or 3 weeks (whichever is shorter).

Any antibody therapy < 5 half-lives from first dose of study treatment (or 4 weeks since last therapy, whichever is shorter).

Chemotherapy with nitrosoureas or mitomycin C < 6 weeks from first dose of study treatment. Other chemotherapy < 3 weeks prior to first dose of study treatment.

Radiation therapy (including radiofrequency ablation) < 1 week prior to initiation of study treatment. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible.

Trial design

Design model

Sequential

Treatments tested in this trial

  • XL309

    Drug

    XL309 will be administered orally per assigned schedule.

  • Olaparib

    Drug

    Olaparib will be administered orally per assigned schedule.

Treatment groups

429 Participants
are divided into 4 treatment groups
Group A: Dose Escalation Single Agent EvaluationExperimental treatment 1 intervention
Group B: Dose Escalation Combination TherapyExperimental treatment 2 interventions
Group C: Cohort Expansion Stage Single Agent EvaluationExperimental treatment 1 intervention
Group D: Cohort Expansion Stage Combination Therapy EvaluationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose Escalation Stage: Incidence of TEAEs and SAEs; AEs Leading to Dose Modification, Discontinuation, or Death; and Laboratory Abnormalities

Adverse events will be recorded and severity graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame
Approximately 24 months
2

Dose Escalation Stage: Incidence of Dose-Limiting Toxicities (DLTs)

Time frame
Approximately 24 months
3

Dose Escalation Stage: XL309 Exposure Over Time Measured as Area Under the Plasma Concentration Curve (AUC)

Time frame
Approximately 24 months
4

Dose Escalation Stage: XL309 Maximum Plasma Concentration (Cmax)

Time frame
Approximately 24 months

Secondary outcomes

1

Dose Escalation Stage: Olaparib Exposure Over Time Measured as Area Under the Plasma Concentration Curve (AUC) at Steady State

Time frame
Approximately 24 months
2

Dose Escalation Stage: Olaparib Cmax at Steady State

Time frame
Approximately 24 months
3

Dose Escalation Stage: Olaparib Ctrough at Steady State

Time frame
Approximately 24 months
4

Cohort Expansion Stage: Concentration of XL309 in Plasma at Specified Time Points

Time frame
Approximately 24 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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