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Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067

ConditionsCancerSolid TumorMelanomaRenal Cell CarcinomaTriple-negative Breast CancerNon Small Cell Lung CancerSquamous Cell Carcinoma of the Head and NeckCarcinomaMSI-High
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSimcha IL-18, Inc.

About this trial

This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab \[Gazyva®\] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients aged ≥18 years

Must provide written informed consent and any authorizations required by local law

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Have histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor

Disqualifiers

History of another malignancy

Known symptomatic brain metastases requiring >10 mg/day of prednisolone or equivalent

Significant cardiovascular disease (MI, thrombotic events,) within 6 months prior to study treatmentSignificant ECG abnormalities (Phase 1a and 2 monotherapy only) including unstable cardiac arrhythmia requiring medication, second-degree atrioventricular block type II, third degree AV

Any degree of respiratory compromise (from either malignant or non-malignant disease)

Trial design

Design model

Sequential

Treatments tested in this trial

  • ST-067

    Biological/Vaccine

    ST-067 is an engineered variant of human interleukin-18.

  • Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA]

    Biological/Vaccine

    Obinutuzumab is a humanized anti-CD20 monoclonal antibody of the IgG1 subclass. It recognizes a specific epitope of the CD20 molecule found on B-cells.

  • pembrolizumab

    Biological/Vaccine

    Pembrolizumab is a potent humanized immunoglobulin G4 monoclonal antibody.

Treatment groups

316 Participants
are divided into 4 treatment groups
Group A: Phase 1a, Dose EscalationExperimental treatment 1 intervention
Group B: Phase 2, ExpansionExperimental treatment 1 intervention
Group C: Phase 1a, Dose Escalation, ST-067 SC + Obinutuzumab Pre-treatmentExperimental treatment 2 interventions
Group D: Phase 1 combination therapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Determine the maximum tolerated dose of ST-067 in phase 1a monotherapy

Patients will be enrolled at a dose level that is predicted to be the MTD

Time frame
Day 29
2

Evaluate the overall safety and tolerability of ST-067 in combination with pembrolizumab

In patients experiencing insufficient response to a checkpoint inhibitor (PD-1) therapy administered alone or in combination.

Time frame
Day 29
3

Number of Participants With Treatment-Related Adverse Events

AE assessed by CTCAE 5.0

Time frame
Day 29
4

Initial assessment of efficacy in phase 2

Investigator-assessed ORR, defined as either a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on computed tomography (CT) or magnetic resonance imaging (MRI) scans

Time frame
At 8 weeks

Secondary outcomes

1

PK

Peak Plasma Concentration (Cmax)

Time frame
Day 29
2

ADA

Incidence of ADA to ST-067

Time frame
Day 29

Other outcomes

Sponsors and contacts

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

Simcha IL-18, Inc.

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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