← 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
Patients with histologically confirmed advanced or metastatic solid tumors with selected tumor histologies
ECOG performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 24 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and works well alone or with another cancer drug.

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.Check my eligibility
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).See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is advanced or has spread and has been confirmed by a biopsy.
Select...
I am fully active or can carry out light work.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety evaluation of OMTX705
Secondary outcome measures
Evaluation of OMTX705 Immunogenicity
Evaluation of the OMTX705 Pharmacokinetics
Exercise, Aerobic
Other outcome measures
Evaluation of OMTX705 biomarkers
Evaluation of OMTX705 payload metabolites
Evaluation of QTc prolongation
+3 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%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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 2
~2010

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

Frequently Asked Questions

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

To what extent could OMTX705 be detrimental to those involved in the trial?

"OMTX705's safety and efficacy have been tested to a lesser extent, thus we assign it a rating of 1."

Answered by AI

Is registration for this experiment still available?

"The information accessible on clinicaltrials.gov reveals that, as of September 16th 2022, this trial is presently not enlisting new participants. Despite this, there are 2 502 other studies searching for volunteers at the moment."

Answered by AI
~31 spots leftby Oct 2024