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STK-012 for Gastroesophageal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gastroesophageal Cancer+11 MoreSTK-012 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Gastroesophageal Cancer
  • Stomach Cancer
  • Lynch Syndrome
  • Bladder Cancer
  • Non-Small Cell Lung Cancer
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Ovarian Cancer
  • Melanoma
  • Advanced Solid Tumors
  • Kidney Cancer
  • Cervical Cancer
  • Microsatellite Instability High

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
NGM438
1
SRF388
1
Pembrolizumab

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Up to 24 months

1 cycle (21 days)
Dose limiting toxicities (DLTs)
Day 30
Area under the curve (AUC) of STK-012
Half-life (T1/2) of STK-012
Immunogenicity
Maximum concentration (Cmax) of STK-012
Time of maximum concentration (Tmax) of STK-012
Day 90
Adverse events
Up to 24 months
Objective response rate (ORR)
Overall Survival (OS)
Progression-free survival (PFS)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
NGM438
1
SRF388
1
Pembrolizumab

Side Effects for

Pembrolizumab+EP
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
21%Diarrhoea
20%Cough
17%Asthenia
17%Dyspnoea
16%Vomiting
14%Pyrexia
14%Dizziness
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Trial Design

7 Treatment Groups

Part D: Dose expansions
1 of 7
Part A: STK-012 monotherapy dose escalation
1 of 7
Part B: STK-012 + pembrolizumab combination dose escalation
1 of 7
Part A: STK-012 weekly (QW) monotherapy dose escalation
1 of 7
Part C: STK-012 Q3W + pembrolizumab dose escalation
1 of 7
Part B: STK-012 every three weeks (Q3W) monotherapy dose escalation
1 of 7
Part C: STK-012 + pembrolizumab combination dose expansion
1 of 7

Experimental Treatment

202 Total Participants · 7 Treatment Groups

Primary Treatment: STK-012 · No Placebo Group · Phase 1

Part D: Dose expansionsExperimental Group · 2 Interventions: STK-012, Pembrolizumab · Intervention Types: Drug, Drug
Part A: STK-012 monotherapy dose escalation
Drug
Experimental Group · 1 Intervention: STK-012 · Intervention Types: Drug
Part B: STK-012 + pembrolizumab combination dose escalationExperimental Group · 2 Interventions: STK-012, Pembrolizumab · Intervention Types: Drug, Drug
Part A: STK-012 weekly (QW) monotherapy dose escalation
Drug
Experimental Group · 1 Intervention: STK-012 · Intervention Types: Drug
Part C: STK-012 Q3W + pembrolizumab dose escalationExperimental Group · 2 Interventions: STK-012, Pembrolizumab · Intervention Types: Drug, Drug
Part B: STK-012 every three weeks (Q3W) monotherapy dose escalation
Drug
Experimental Group · 1 Intervention: STK-012 · Intervention Types: Drug
Part C: STK-012 + pembrolizumab combination dose expansionExperimental Group · 2 Interventions: STK-012, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

SynthekineLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must have selected tumor types and must have progressed after standard of care treatment, or be intolerant to treatment, or refuse standard treatment.
References

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