E-602 for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Small Cell Lung Cancer+15 MoreE-602 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, E-602, to see if it is safe and effective when used alone or with another drug, pembrolizumab.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • Esophagogastric Junction
  • Cancer
  • Melanoma
  • Ovarian Cancer
  • Breast Cancer
  • Pancreatic Cancer
  • Colon Cancer
  • Bladder Cancer
  • Esophagogastric Junction Cancer
  • Stomach Cancer
  • Head and Neck Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

7 Primary · 10 Secondary · Reporting Duration: 16 Months

12 Months
Noncompartmental PK Parameters of E-602 (Phase 1)
Noncompartmental PK Parameters of E-602 (Phase 2)
Objective Response Rate (Phase 1)
Objective Response Rate (Phase 2)
13 Months
Subjects with Antidrug Antibodies (Phase 1)
Subjects with Antidrug Antibodies (Phase 2)
15 Months
Immune-Related Toxicities (Phase 1)
Incidence of AEs and SAEs (Phase 1)
Incidence of AEs and SAEs (Phase 2)
Overall Survival (Phase 1)
Overall Survival (Phase 2)
Progression Free Survival (Phase 1)
Progression Free Survival (Phase 2)
16 Months
Duration of Response (Phase 1)
Duration of Response (Phase 2)
Immune-Related Toxicities (Phase 2)
21 days
Dose-Limiting Toxicities (Phase 1)

Trial Safety

Safety Progress

1 of 3

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

4 Treatment Groups

Dose Escalation - Combination
1 of 4
Expansion - Monotherapy
1 of 4
Expansion - Combination
1 of 4
Dose Escalation - Monotherapy
1 of 4

Experimental Treatment

273 Total Participants · 4 Treatment Groups

Primary Treatment: E-602 · No Placebo Group · Phase 1 & 2

Dose Escalation - CombinationExperimental Group · 2 Interventions: E-602, Pembrolizumab · Intervention Types: Biological, Biological
Expansion - Monotherapy
Biological
Experimental Group · 1 Intervention: E-602 · Intervention Types: Biological
Expansion - CombinationExperimental Group · 2 Interventions: E-602, Pembrolizumab · Intervention Types: Biological, Biological
Dose Escalation - Monotherapy
Biological
Experimental Group · 1 Intervention: E-602 · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2240

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 16 months

Who is running the clinical trial?

Palleon Pharmaceuticals, Inc.Lead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a performance status of 0 or 1.
The subject has a disease that is measurable by RECIST v.1.1.1.
You have adequate bone marrow, coagulation, renal function, and liver function as determined by laboratory tests.