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MPT-0118 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Monopteros Therapeutics Inc.
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 1 year
Awards & highlights

Study Summary

This trial is testing a new drug, MPT-0118, on people with cancer that has spread or returned after previous treatment. The trial will have 3 parts. The first part will test different doses of MPT-0118 to find the best dose. The second part will test MPT-0118 with another drug, pembrolizumab. The third part will test MPT-0118 with pembrolizumab in a larger group of people.

Eligible Conditions
  • Solid Tumors
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: To determine the MTD or the RP2D of MPT-0118
Part B: To determine the MTD or the RP2D of MPT-0118 + pembrolizumab
Part C: Duration of response (DoR) based on RECIST v1.1 and iRECIST
+3 more
Secondary outcome measures
Part A and B: DoR based on RECIST v 1.1 and iRECIST
Part A and B: Maximum plasma concentration of MPT-0118
Part A and B: ORR based on RECIST v 1.1 and iRECIST
+2 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%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part C:Experimental Treatment1 Intervention
Dose-expansion oral MPT-0118 BID + pembrolizumab (IV)
Group II: Part B:Experimental Treatment1 Intervention
Dose-escalation oral MPT-0118 BID + pembrolizumab (IV)
Group III: Part A:Experimental Treatment1 Intervention
Dose-escalation oral MPT-0118 BID

Find a Location

Who is running the clinical trial?

Monopteros Therapeutics Inc.Lead Sponsor
Arthur DeCillis, MDStudy DirectorMonopteros Therapeutics Inc.

Frequently Asked Questions

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

How many facilities have this research project been implemented in?

"At present, the study is being conducted in 5 medical institutions such as St. John's Cancer Center (Santa Monica), Massachusetts General Hospital (Boston), and NEXT Oncology (San Antonio) with two other sites offering trial participation."

Answered by AI

How many individuals have volunteered to take part in this clinical investigation?

"This clinical trial necessitates 70 individuals that meet the qualifications. These people can partake in this investigation at two medical centres, St. John's Cancer Center of Santa Monica, CA and Massachusetts General Hospital in Boston, MA."

Answered by AI

Are there any opportunities to join this medical experiment at present?

"In accordance with the information on clinicaltrials.gov, this trial is actively searching for volunteers to participate. The medical research was initially posted on April 13th 2021 and its listing has been most recently revised on September 15th 2021."

Answered by AI

What previous experiments have explored the effects of MPT-0118?

"Currently, 963 clinical trials of MPT-0118 are ongoing. 122 of these studies have reached the Phase 3 level. Most of these tests take place in Houston but 35772 other sites worldwide also run similar experiments."

Answered by AI

What are the accepted applications of MPT-0118?

"MPT-0118 is commonly used to manage malignant neoplasms, but can also be beneficial for treating severe cases of melanoma, microsatellite instability high and diseases that have progressed as a result of chemotherapy."

Answered by AI

Has MPT-0118 acquired sanction from the FDA?

"Based on the limited data currently available, our team at Power believes MPT-0118 to possess a score of 1 in terms of safety and efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of MPT-0118 in Subjects With Advanced or Metastatic Refractory Solid Tumors
2021. "A Study of MPT-0118 in Subjects With Advanced or Metastatic Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04859777.
~17 spots leftby Apr 2025
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