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A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

The purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically documented advanced (metastatic and/or unresectable) solid tumor.

Participants must have received prior anticancer treatment for the disease under study: this may include chemotherapy, immunotherapy, or targeted therapy as considered standard of care, where clinically appropriate.

IO monotherapy considered clinically appropriate and reasonably likely to permit study participation through at least the PK-evaluable period, in the investigator's judgment.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment with no deterioration.

Disqualifiers

Any severe or uncontrolled systemic diseases, which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.

History of organ transplant or allogeneic stem cell transplant.

History of another primary malignancy that was active within past 2 years.

Persistent toxicities caused by previous anticancer treatment(s) excluding alopecia, not yet improved to Grade ≤ 1 or baseline.

Trial design

Design model

Sequential

Treatments tested in this trial

  • IV Rilvegostomig

    Drug

    Rilvegostomig administered IV.

  • Recombinant Human Hyaluronidase (rHu)

    Drug

    rHu administered subcutaneously.

  • SC Rilvegostomig

    Drug

    Rilvegostomig administered subcutaneously.

  • SC rilvegostomig + rHu

    Drug

    SC rilvegostomig + rHu administered subcutaneously.

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Part 1 (dose finding): Cohort A - SC Rilvegostomig Dose Level 1 (DL1) and rHuExperimental treatment 3 interventions
Group B: Part 1 (dose finding): Cohort B - SC Rilvegostomig DL2 and rHuExperimental treatment 3 interventions
Group C: Part 2 (dose confirmation): SC Rilvegostomig and rHuExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Area under the Concentration-time Curve During One Dosing Interval (AUCtau)

Bioavailability based on AUCtau at first SC dose will be determined.

Time frame
From Day 1 up to end of Cycle 2 in Part 1 and end of Cycle 1 in Part 2 (each cycle will be of 3 weeks)

Secondary outcomes

1

Number of participants with adverse events (AEs)

To assess safety and tolerability of SC rilvegostomig. Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE version 5.0), clinical laboratory assessments, vital signs, physical examinations, and ECOG performance status.

Time frame
From Day 1 up to 90 days post last dose (Up to approximately 23 months)
2

Observed Lowest Concentration before the Next Dose is Administered (Ctrough)

To assess drug exposure (Ctrough) of SC rilvegostomig comparable to that of IV rilvegostomig.

Time frame
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 23 months).
3

Average drug concentration over a dosing interval (Cavg)

To assess drug exposure (Cavg) of SC rilvegostomig comparable to that of IV rilvegostomig.

Time frame
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 23 months).
4

AUCtau

To assess drug exposure of SC rilvegostomig comparable to that of IV rilvegostomig.

Time frame
From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 23 months).

Other outcomes

Sponsors and contacts

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

AstraZeneca

Lead sponsor

Parexel

Collaborator

Source ClinicalTrials.gov
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