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Monoclonal Antibodies

STK-012 + Pembrolizumab for Cancer

Phase 1
Recruiting
Research Sponsored by Synthekine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, STK-012, to see if it can shrink solid tumors. The trial will test STK-012 alone and in combination with another drug, pembrolizumab.

Who is the study for?
This trial is for adults with certain advanced solid tumors who have tried standard treatments without success, can't tolerate them, or chose not to use them. They must provide a tumor tissue sample and if they have brain metastases, these should be treated and stable. People can't join if they've had recent cancer therapy or radiotherapy.Check my eligibility
What is being tested?
The study tests STK-012 alone and combined with Pembrolizumab in patients with specific solid tumors. It's the first time humans are trying STK-012, starting with low doses that increase gradually to find the safest dose that works best when given together.See study design
What are the potential side effects?
Possible side effects of STK-012 and Pembrolizumab may include immune system reactions affecting organs, fatigue, skin issues, flu-like symptoms from cytokine therapies (like fever or chills), as well as potential infusion-related reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events
Dose limiting toxicities (DLTs)
Secondary outcome measures
Area under the curve (AUC) of STK-012
Half-life (T1/2) of STK-012
Immunogenicity
+5 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part D: Dose expansionsExperimental Treatment2 Interventions
STK-012 will be administered at the RP2D SC as monotherapy and in combination with a fixed dose of pembrolizumab IV Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.
Group II: Part C: STK-012 Q3W + pembrolizumab dose escalationExperimental Treatment2 Interventions
STK-012 will be administered in sequential ascending doses SC Q3W in combination with a fixed dose of pembrolizumab intravenously (IV) Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.
Group III: Part B: STK-012 every three weeks (Q3W) monotherapy dose escalationExperimental Treatment1 Intervention
STK-012 will be administered in sequential ascending doses as monotherapy SC Q3W until unacceptable toxicity, disease progression, or withdrawal of consent.
Group IV: Part A: STK-012 weekly (QW) monotherapy dose escalationExperimental Treatment1 Intervention
STK-012 will be administered in sequential ascending doses as monotherapy subcutaneously (SC) QW until unacceptable toxicity, disease progression, or withdrawal of consent.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

SynthekineLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05098132 — Phase 1
Kidney Cancer Research Study Groups: Part A: STK-012 weekly (QW) monotherapy dose escalation, Part D: Dose expansions, Part C: STK-012 Q3W + pembrolizumab dose escalation, Part B: STK-012 every three weeks (Q3W) monotherapy dose escalation
Kidney Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05098132 — Phase 1
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05098132 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the main ambition of this trial?

"Synthekine, the trial's sponsor, has stated that Dose Limiting Toxicities (DLTs) will be used as their primary metric for success. Secondary objectives include measuring Maximum Concentration (Cmax), Area Under the Curve (AUC), and Half-Life (T1/2). These outcomes will all be evaluated at multiple timescales after STK-012 administration in both monotherapy and combination with pembrolizumab settings."

Answered by AI

How many centers are involved in the administration of this clinical trial?

"Currently, 5 trial sites are operational in Pittsburgh, Fairfax and Nashville alongside other locales. It is wise to select a location closest to you since it minimizes the need for travelling if one decides to participate in this experiment."

Answered by AI

Is the research team currently searching for new participants?

"Affirmative. Clinicaltrials.gov's records show that this research is actively enrolling participants, having been published on the 25th of January 2022 and subsequently amended on July 22nd . 202 patients are expected to join from 5 different medical centres."

Answered by AI

How many participants have enrolled in this trial thus far?

"Affirmative. The information on clinicaltrials.gov indicates that this investigation is currently recruiting participants, with the first post appearing on January 25th 2022 and a recent revision occurring July 22nd of the same year. 202 individuals need to be gathered from five distinct sites for the trial's completion."

Answered by AI

What therapeutic applications is STK-012 most commonly employed for?

"STK-012 can be used to address malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

To what extent does STK-012 pose a health risk to individuals?

"Due to the limited data affirming its safety and efficacy, STK-012 was assigned a score of 1 on our team's measurement scale."

Answered by AI

What prior investigations have been conducted with regard to STK-012?

"STK-012 was initially investigated by City of Hope in 2010, with a further 251 trials having been completed since then. Currently, 963 studies are recruiting participants, the majority being conducted within Pittsburgh, Pennsylvania."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors
2022. "Phase 1a/1b Study of STK-012 Monotherapy and in Combination With Pembrolizumab in Patients With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05098132.
~78 spots leftby Oct 2025
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