Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers (SYNERGY-101)

Synthekine

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: 1st Line NSCLC; Advanced Solid Tumor; Untreated Advanced NSCLC; Non Small Cell Lung Cancer

Treatments: Drug: pemetrexed; Drug: pembrolizumab; Drug: STK-012; Drug: carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05098132

STK-012-101

Details and patient eligibility

About

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, non-squamous, non-small cell lung cancer.

Full description

Phase 1 [closed to enrollment]: The phase 1a portion is a dose escalation study to evaluate STK-012 as monotherapy and in combination therapy in patients with selected solid tumors. The phase 1b portion is a dose expansion study to evaluate STK-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.

Phase 2 [open to enrollment]: The phase 2 portion is a randomized, open label study to evaluate STK-012 at two dose levels in combination with standard of care (SoC) pembrolizumab, pemetrexed and carboplatin, versus SoC, in patients with first line, PD-L1 negative, non-squamous, non-small cell lung cancer.

Enrollment: 364 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Selected Inclusion Criteria:

1. Phase 1 [closed to enrollment]

2. Phase 2 [open to enrollment]:

   • 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.
   • No prior systemic therapy for advanced/metastatic NSQ NSCLC.
   • Tumor is PD-L1 negative (TPS <1%) by local testing.
   • No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy.

Selected Exclusion Criteria:

1. Phase 1 [closed to enrollment]

2. Phase 2 [open to enrollment]:

   • Prior immune checkpoint inhibitor (anti-PD[L]1 and/or anti-CTLA-4) treatment
   • Tumor with small cell, neuroendocrine, or sarcomatoid components.
   • Received radiotherapy ≤ 7 days of the first dose of study treatment.
   • Known untreated central nervous system metastases
   • Any history of carcinomatous meningitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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364 participants in 9 patient groups

Phase 1a: STK-012 monotherapy dose escalation

Experimental group

Description:

STK-012 subcutaneous (SC) as monotherapy in selected solid tumor indications

Treatment:

Drug: STK-012

Phase 1a: STK-012 + pembrolizumab dose escalation

Experimental group

Description:

STK-012 SC + pembrolizumab intravenously (IV) in selected solid tumor indications

Treatment:

Drug: STK-012

Drug: pembrolizumab

Phase 1a: STK-012 + standard of care (SoC) dose escalation

Experimental group

Description:

STK-012 SC + SoC IV in first-line non-squamous (NSQ) NSCLC

Treatment:

Drug: carboplatin

Drug: STK-012

Drug: pembrolizumab

Drug: pemetrexed

Phase 1b: STK-012 monotherapy expansion

Experimental group

Description:

STK-012 SC monotherapy in selected solid tumor indications

Treatment:

Drug: STK-012

Phase 1b: STK-012 + pembrolizumab dose expansion

Experimental group

Description:

STK-012 SC will be administered in combination with pembrolizumab IV in selected solid tumor indications

Treatment:

Drug: STK-012

Drug: pembrolizumab

Phase 1b: STK-012 + SoC dose expansion

Experimental group

Description:

STK-012 SC + SoC IV in first-line PD-L1 negative NSQ NSCLC

Treatment:

Drug: carboplatin

Drug: STK-012

Drug: pembrolizumab

Drug: pemetrexed

Phase 2: Arm A

Experimental group

Description:

STK-012 2.25 mg SC Q3W + SoC IV in first-line PD-L1 negative NSQ NSCLC

Treatment:

Drug: carboplatin

Drug: STK-012

Drug: pembrolizumab

Drug: pemetrexed

Phase 2: Arm B

Experimental group

Description:

STK-012 1.5 mg SC Q3W + SoC IV in first-line PD-L1 negative NSQ NSCLC

Treatment:

Drug: carboplatin

Drug: STK-012

Drug: pembrolizumab

Drug: pemetrexed

Phase 2: Arm C

Active Comparator group

Description:

SoC IV in first-line PD-L1 negative NSQ NSCLC

Treatment:

Drug: carboplatin

Drug: pembrolizumab

Drug: pemetrexed