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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 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
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
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

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.

Find a Location

Who is running the clinical trial?

Oncomatryx Biopharma S.L.Lead Sponsor
Ignacio García-Ribas, MDStudy DirectorOncomatryx Biopharm, S.L.

Media Library

OMTX705 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05547321 — Phase 1
Solid Tumors Research Study Groups: Monotherapy (OMTX705), Combination (OMTX705 + pembrolizumab)
Solid Tumors Clinical Trial 2023: OMTX705 Highlights & Side Effects. Trial Name: NCT05547321 — Phase 1
OMTX705 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05547321 — Phase 1
~40 spots leftby Oct 2025