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Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

ConditionsAdvanced Solid TumorNon Small Cell Lung CancerUntreated Advanced NSCLC1st Line NSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSynthekine

About this trial

This is a phase 1/2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative or STK11 mutated, non-squamous, non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Phase 1: Selected advanced solid tumors

Diagnosis of non-small cell lung cancer (NSCLC).

Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment.

Non-squamous (NSQ) cell histology.

Disqualifiers

Prior immune checkpoint inhibitor (anti-PD[L]1 and/or anti-CTLA-4) treatment

Rare tumor subtypes (mucinous histology or tumors with small cell, neuroendocrine, or sarcomatoid components).

Received radiotherapy ≤ 7 days of the first dose of study treatment.

Known active central nervous system metastases

Trial design

Design model

Parallel

Treatments tested in this trial

  • STK-012

    Drug

    Engineered Interleukin-2 (IL-2) selective for antigen activated T cells

  • pembrolizumab KEYTRUDA®

    Drug

    anti-PD-1 monoclonal antibody

  • pemetrexed

    Drug

    chemotherapy

  • carboplatin

    Drug

    chemotherapy

Treatment groups

364 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Phase 1a: STK-012 monotherapy dose escalationExperimental treatment 1 intervention
Group B: Phase 1a: STK-012 + pembrolizumab dose escalationExperimental treatment 2 interventions
Group C: Phase 1a: STK-012 + standard of care (SoC) dose escalationExperimental treatment 4 interventions
Group D: Phase 1b: STK-012 monotherapy expansionExperimental treatment 1 intervention
Group E: Phase 1b: STK-012 + pembrolizumab dose expansionExperimental treatment 2 interventions
Group F: Phase 1b: STK-012 + SoC dose expansionExperimental treatment 4 interventions
Group G: Phase 2: Arm AExperimental treatment 4 interventions
Group H: Phase 2: Arm BExperimental treatment 4 interventions
Group I: Phase 2: Arm CActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Phase 1a: Treatment emergent adverse events (TEAEs)

Incidence of TEAEs in participants with select advanced solid tumors

Time frame
From 1st dose of study treatment through 90 days after last dose
2

Phase 1a: Serious adverse events (SAEs)

Incidence of SAEs in participants with select advanced solid tumors

Time frame
From 1st dose of study treatment through 90 days after last dose
3

Phase 1a: Dose limiting toxicities (DLTs)

Incidence of DLTs in participants with select advanced solid tumors

Time frame
Cycle 1, Days 1 through 21
4

Phase 1a: Deaths

Incidence of death in participants with select advanced solid tumors

Time frame
From 1st dose of study treatment until death, up to 4 years

Secondary outcomes

1

Phase 1: ORR

Assessment of preliminary efficacy, specifically ORR, in select advanced solid tumors. ORR is the proportion of subjects with confirmed CR or confirmed PR per investigator assessment.

Time frame
From enrollment until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years
2

Phase 1: Progression free survival (PFS)

Assessment of preliminary efficacy, specifically PFS, in select advanced solid tumors.

Time frame
From enrollment until first documentation of disease progression per investigator assessment or death due to any cause, whichever occurs first, up to 4 years
3

Phase 1: Overall survival (OS)

Assessment of preliminary efficacy, specifically OS, in select advanced solid tumors.

Time frame
From enrollment until death due to any cause, up to 4 years
4

Phase 1/2: STK-012 ADAs

Anti-drug antibodies (ADA) to assess immunogenicity of STK-012 in advanced NSCLC and other select solid tumors.

Time frame
From screening through 30 days after last dose of STK-012

Other outcomes

Sponsors and contacts

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

Synthekine

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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