Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05098132 · ClinicalTrials.gov registry record · Phase 1
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
A Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, sponsored by Synthekine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 364
- Enrollment target
- 20
- Study locations
NCT05098132: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, sponsored by Synthekine.
NCT05098132 is a Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor that is actively recruiting participants, run by Synthekine. The registered enrollment target is 364 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05098132, a Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, is actively recruiting participants, sponsored by Synthekine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 364 participants
- Enrollment target
- 20
- Study locations
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, non-squamous, non-small cell lung cancer.
Primary Outcome
Incidence of TEAEs in participants with select advanced solid tumors
Conditions Studied
Interventions
- DRUG pembrolizumab
- DRUG carboplatin
- DRUG STK-012
- DRUG pemetrexed
Study Locations (20)
California
- Beverly Hills Cancer Center - Beverly Hills
- Providence Medical Foundation - Fullerton
- UC San Diego Moores Cancer Center - La Jolla
- Hoag Memorial Hospital Presbyterian - Newport Beach
- UCLA Hematology/Oncology - Santa Monica - Santa Monica
New York
- Northwell Health - Lake Success
- NYU Langone Health - New York
- Columbia University Irving Medical Center - New York
- Memorial Sloan-Kettering Cancer Center - New York
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Arizona
- University of Arizona Cancer Center - Tucson
Connecticut
- Yale New Haven Hospital, Yale Cancer Center - New Haven
District of Columbia
- Georgetown University - Washington D.C.
Georgia
- Winship Cancer Institute, Emory University - Atlanta
Minnesota
- HealthPartners Cancer Center at Regions Hospital - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 364 participants |
| Start Date | 2022-01-25 |
| Est. Completion | 2029-01 |
| Phase | Phase 1 |
What NCT05098132 shows while recruiting
NCT05098132 is an interventional study that assigns participants to a tested intervention. The registered 364 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (44% lower).
The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which pembrolizumab is the first listed.
NCT05098132 names 20 study sites across 11 states, led by California, New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05098132 about?
NCT05098132 is a clinical study titled "Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers". 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 ...
What is the current status of trial NCT05098132?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 364 participants. The study started on 2022-01-25. Estimated completion is 2029-01.
What conditions does trial NCT05098132 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Advanced Solid Tumor, Untreated Advanced NSCLC, 1st Line NSCLC.
What interventions are being tested in trial NCT05098132?
The interventions under investigation include: pembrolizumab (DRUG), carboplatin (DRUG), STK-012 (DRUG), pemetrexed (DRUG).
Who is sponsoring clinical trial NCT05098132?
This trial is sponsored by Synthekine, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05098132 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05098132's enrollment target sits among peer trials
364 106th of 454 higher than 348 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
RECRUITING · Phase 1
-
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
RECRUITING · Phase 1
-
A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
RECRUITING · Phase 1
-
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
RECRUITING · Phase 1
-
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04510597 · 364 participants · Phase 3
Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial
- NCT05330221 · 364 participants · NA
Project 2: ACHIEVE- HF
- NCT05673148 · 364 participants · Phase 3
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur Study
- NCT07123649 · 364 participants · Phase 2
Individualizing Approaches to Surveillance Mammography in Older Breast Cancer Survivors - The I-MAMMO Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI