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

Condition(s) studied

Investigational drug(s) / intervention(s)

STK-012: Engineered Interleukin-2 (IL-2) selective for antigen activated T cells

pembrolizumab KEYTRUDA®: anti-PD-1 monoclonal antibody

pemetrexed: chemotherapy

carboplatin: chemotherapy

Study summary

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

Primary outcome measure(s)

• Phase 1a: Treatment emergent adverse events (TEAEs) — From 1st dose of study treatment through 90 days after last dose
  Incidence of TEAEs in participants with select advanced solid tumors
• Phase 1a: Serious adverse events (SAEs) — From 1st dose of study treatment through 90 days after last dose
  Incidence of SAEs in participants with select advanced solid tumors
• Phase 1a: Dose limiting toxicities (DLTs) — Cycle 1, Days 1 through 21
  Incidence of DLTs in participants with select advanced solid tumors
• Phase 1a: Deaths — From 1st dose of study treatment until death, up to 4 years
  Incidence of death in participants with select advanced solid tumors
• Phase 1b: TEAEs at the RP2D — From 1st dose of study treatment through 90 days after last dose
  Incidence of TEAEs at the recommended phase 2 dose (RP2D) in participants with select advanced solid tumors
• Phase 1b: SAEs at the RP2D — From 1st dose of study treatment through 90 days after last dose
  Incidence of SAEs at the RP2D in participants with select advanced solid tumors
• Phase 1b: Deaths at the RP2D — From 1st dose of study treatment until death, up to 4 years
  Incidence of death at the RP2D in participants with select advanced solid tumors
• Phase 2: Overall response rate (ORR) in Arm A versus Arm C — From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years
  To compare the ORR in 1L NSQ NSCLC (PD-L1\<1% or STK11m) subjects treated with STK-012 2.25 mg + SoC vs. SoC (Arms A vs. C). ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per BICR.

Trial sites (47)

+ 7 more sites — see the full list on the official registry below.

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