What is the mechanism of action of this treatment?

Pembrolizumab, a PD-1 inhibitor, enhances the immune system's ability to detect and destroy cancer cells by blocking the PD-1 pathway, which tumors often exploit to evade immune detection. This is particularly important for solid tumor patients as it can lead to better tumor control and improved survival rates. Other treatments like chemotherapy target rapidly dividing cells, and targeted therapies focus on specific genetic mutations within the tumor, offering a more personalized approach to cancer treatment. Understanding these mechanisms allows for more effective and tailored treatment strategies for patients with solid tumors.

What side effects are associated with this type of intervention?

Common side effects of PD-1 inhibitors like Pembrolizumab in the treatment of solid tumors include fatigue, rash, pruritus, diarrhea, and nausea. Severe adverse events can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. For novel agents with unknown mechanisms, such as OMTX705, side effects can vary but often include similar immune-related adverse events, as well as potential infusion-related reactions and organ-specific toxicities. It is essential for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has received FDA approval for the treatment of various solid tumors, including non-small cell lung cancer (NSCLC), melanoma, and gastric cancer, among others. Other PD-1 inhibitors like Nivolumab have also been approved for similar indications. Additionally, combination therapies involving PD-1 inhibitors and other agents, such as chemotherapy or other immunotherapies, have been approved to enhance treatment efficacy. These approvals are based on clinical trials demonstrating improved overall survival and progression-free survival in patients with advanced or metastatic solid tumors.

What other types of research exist?

Promising alternatives to OMTX705 and pembrolizumab for solid tumors include: 1) Dostarlimab (Jemperli) for mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, 2) Lenvatinib plus pembrolizumab for advanced endometrial cancer with progression after platinum-based therapy, and 3) Enfortumab vedotin for advanced urothelial carcinoma after PD-1 or PD-L1 inhibitors. These treatments have shown efficacy in clinical trials and may be viable options in 2024.

← Back to Search

Monoclonal Antibodies

OMTX705 + Pembrolizumab for Cancer

Phase 1

Recruiting

Research Sponsored by Oncomatryx Biopharma S.L.

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 through study completion, an average of 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, OMTX705, alone or with pembrolizumab, in patients with advanced cancer who have no other treatment options. The study aims to find the safest dose and see if the combination works better than OMTX705 alone.

Who is the study for?

Adults with advanced or metastatic solid tumors without standard treatment options can join this trial. They must have measurable disease, good organ function, and an ECOG performance status of 0-1. Women who can bear children and men with partners who can must use contraception. Exclusions include active infections, certain heart conditions, pregnancy, recent other cancer treatments, uncontrolled brain metastases, and specific medication interactions.

What is being tested?

OMTX705 is being tested alone and combined with Pembrolizumab to treat advanced cancers in patients lacking other options. This Phase 1 study will gradually increase doses to find safe levels (dose-escalation) before expanding the number of participants at those levels (expansion phase).

What are the potential side effects?

Possible side effects may include reactions related to the immune system such as inflammation in various organs due to OMTX705 or Pembrolizumab's action on the body's defenses. Other common drug-related issues could be fatigue, digestive problems or changes in blood counts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety evaluation of OMTX705

Secondary study objectives

Evaluation of OMTX705 Immunogenicity

Evaluation of the OMTX705 Pharmacokinetics

Exercise, Aerobic

Other study objectives

Evaluation of OMTX705 biomarkers

Evaluation of OMTX705 payload metabolites

Evaluation of QTc prolongation

+3 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Pneumonia aspiration

Sepsis

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Monotherapy (OMTX705)Experimental Treatment1 Intervention

OMTX705 is administered as single agent.

Group II: Combination (OMTX705 + pembrolizumab)Experimental Treatment2 Interventions

OMTX705 is administered in combination with pembrolizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pembrolizumab, a PD-1 inhibitor, enhances the immune system's ability to detect and destroy cancer cells by blocking the PD-1 pathway, which tumors often exploit to evade immune detection. This is particularly important for solid tumor patients as it can lead to better tumor control and improved survival rates. Other treatments like chemotherapy target rapidly dividing cells, and targeted therapies focus on specific genetic mutations within the tumor, offering a more personalized approach to cancer treatment. Understanding these mechanisms allows for more effective and tailored treatment strategies for patients with solid tumors.

Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.New therapeutic strategies for malignant pleural mesothelioma.