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

Conditions

• 1st Line NSCLC
• Advanced Solid Tumor
• Non Small Cell Lung Cancer
• Untreated Advanced NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

First listed

Oct 28, 2021

Start date

Jan 25, 2022

Status verified

Jun 2026

Primary completion

Jan 31, 2029

Completion

Jan 31, 2029

Study Design

Enrollment

364 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1a: STK-012 monotherapy dose escalation
  STK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications
• Experimental: Phase 1a: STK-012 + pembrolizumab dose escalation
  STK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications
• Experimental: Phase 1a: STK-012 + standard of care (SoC) dose escalation
  STK-012 SC + SoC IV in first-line non-squamous (NSQ) NSCLC
• Experimental: Phase 1b: STK-012 monotherapy expansion
  STK-012 SC monotherapy in selected solid tumor indications
• Experimental: Phase 1b: STK-012 + pembrolizumab dose expansion
  STK-012 SC will be administered in combination with pembrolizumab IV in selected solid tumor indications
• Experimental: Phase 1b: STK-012 + SoC dose expansion
  STK-012 SC + SoC IV in first-line PD-L1 negative NSQ NSCLC
• Experimental: Phase 2: Arm A
  STK-012 2.25 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC
• Experimental: Phase 2: Arm B
  STK-012 1.5 mg SC Q3W + SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC
• Active Comparator: Phase 2: Arm C
  SoC IV in first-line PD-L1 negative or STK11 mutated, NSQ NSCLC

Primary Outcome Measure

Phase 1a: Treatment emergent adverse events (TEAEs) [ Time Frame: From 1st dose of study treatment through 90 days after last dose ]

Central Contacts

• Synthekine STK-012-101 Contact
  650-606-6319
  [email protected]

Locations (33)

Find similar trials in Tucson, AZ

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