CLINICAL TRIAL

NDI-101150 for Tumors, Solid

Locally Advanced
Metastatic
Refractory
Recruiting · 18+ · All Sexes · Hackensack, NJ

A Study of NDI 1150-101 in Patients With Solid Tumors

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About the trial for Tumors, Solid

Eligible Conditions
Tumors, Solid · Neoplasms

Treatment Groups

This trial involves 2 different treatments. NDI-101150 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
NDI-101150
DRUG
+
Pembrolizumab
DRUG
Experimental Group 2
NDI-101150
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
In Part 2 of the study, the aim is to evaluate the safety and efficacy of pembrolizumab as a monotherapy or in combination with chemotherapy in patients with advanced or metastatic gastric or GEJ adenocarcinoma for which no standard therapy is available or are refractory to standard therapy. show original
The patient has a disease that is measurable or not measurable using the RECIST v1.1 criteria show original
The Eastern Cooperative Oncology Group (ECOG) has defined performance status 0-1 as "fully active, capable of all self-care activities without assistance. show original
The patient must have received their last dose of any previous anticancer therapies four weeks or more prior to starting treatment with NDI-101150 show original
Life expectancy of ≥ 12 weeks
Recovery from therapy means that their Grade was reduced to a level of 1 or less, or they returned to the baseline status with the exception of alopecia. show original
Patients with adequate bone marrow function
I am willing to have a tumor biopsy if required. show original
Advanced or metastatic tumors that are resistant to standard treatments are eligible for Part 1 of the study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Assessed up to 37 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Assessed up to 37 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Assessed up to 37 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether NDI-101150 will improve 2 primary outcomes and 16 secondary outcomes in patients with Tumors, Solid. Measurement will happen over the course of Cycle 1 and Cycle 2 (each cycle is 21 days in length).

Part 1: Frequency of dose-limiting toxicities (DLTs)
CYCLE 1 AND CYCLE 2 (EACH CYCLE IS 21 DAYS IN LENGTH)
Frequency of DLTs associated with NDI-101150 administration alone (escalation monotherapy cohorts) in patients with advanced solid tumors will be determined to evaluate the MTD and RP2D of NDI-101150 as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors.
CYCLE 1 AND CYCLE 2 (EACH CYCLE IS 21 DAYS IN LENGTH)
Part 1 and Part 2: Number of patients with adverse events (AEs) and Serious adverse events (SAEs)
FROM SCREENING (DAY -28 TO DAY -1) UNTIL SAFETY FOLLOW-UP (>30 DAYS AFTER LAST DOSE) [ASSESSED UP TO 37 MONTHS]
Safety and tolerability of NDI-101150 monotherapy and in combination with pembrolizumab in patients with advanced solid tumors and with specific solid tumors (gastric and GEJ cancer) will be characterized.
FROM SCREENING (DAY -28 TO DAY -1) UNTIL SAFETY FOLLOW-UP (>30 DAYS AFTER LAST DOSE) [ASSESSED UP TO 37 MONTHS]
Part 1 and Part 2: Maximum plasma concentration (Cmax) of NDI-101150
CYCLE 1 DAY 1, CYCLE 2 DAY 1 (PRE-DOSE AND POST-DOSE), CYCLE 1 DAY 2, CYCLE 2 DAY 2 (MONOTHERAPY); AT EOT (END-OF-TREATMENT)/ET (EARLY TERMINATION) [CYCLE LENGTH IS 28 DAYS FOR MONOTHERAPY AND 21 DAYS FOR COMBINATION THERAPY] [ASSESSED UP TO 37 MONTHS]
Cmax of NDI-101150 monotherapy and in combination with pembrolizumab in patients with advanced solid tumors and with specific solid tumors (gastric and GEJ cancer) will be determined.
CYCLE 1 DAY 1, CYCLE 2 DAY 1 (PRE-DOSE AND POST-DOSE), CYCLE 1 DAY 2, CYCLE 2 DAY 2 (MONOTHERAPY); AT EOT (END-OF-TREATMENT)/ET (EARLY TERMINATION) [CYCLE LENGTH IS 28 DAYS FOR MONOTHERAPY AND 21 DAYS FOR COMBINATION THERAPY] [ASSESSED UP TO 37 MONTHS]
Part 1 and Part 2: Accumulation index based on Cmax of NDI-101150
CYCLE 1 DAY 1, CYCLE 2 DAY 1 (PRE-DOSE AND POST-DOSE), AT CYCLE 1 DAY 2, CYCLE 2 DAY 2 (MONOTHERAPY) AND AT EOT/ET [CYCLE LENGTH IS 28 DAYS FOR MONOTHERAPY AND 21 DAYS FOR COMBINATION THERAPY] [ASSESSED UP TO 37 MONTHS]
Accumulation index of NDI-101150 monotherapy and in combination with pembrolizumab in patients with advanced solid tumors and with specific solid tumors (gastric and GEJ cancer) will be determined.
CYCLE 1 DAY 1, CYCLE 2 DAY 1 (PRE-DOSE AND POST-DOSE), AT CYCLE 1 DAY 2, CYCLE 2 DAY 2 (MONOTHERAPY) AND AT EOT/ET [CYCLE LENGTH IS 28 DAYS FOR MONOTHERAPY AND 21 DAYS FOR COMBINATION THERAPY] [ASSESSED UP TO 37 MONTHS]
Part 1: Area under the concentration-time curve in the dosing interval (AUC0-24) of NDI-101150
CYCLE 1 DAY 1, CYCLE 2 DAY 1 (PRE-DOSE AND POST-DOSE), AT CYCLE 1 DAY 2, CYCLE 2 DAY 2 (MONOTHERAPY) AND AT EOT/ET [CYCLE LENGTH IS 28 DAYS FOR MONOTHERAPY AND 21 DAYS FOR COMBINATION THERAPY] [ASSESSED UP TO 37 MONTHS]
AUC0-24 of NDI-101150 monotherapy and in combination with pembrolizumab in patients with advanced solid tumors will be determined.
CYCLE 1 DAY 1, CYCLE 2 DAY 1 (PRE-DOSE AND POST-DOSE), AT CYCLE 1 DAY 2, CYCLE 2 DAY 2 (MONOTHERAPY) AND AT EOT/ET [CYCLE LENGTH IS 28 DAYS FOR MONOTHERAPY AND 21 DAYS FOR COMBINATION THERAPY] [ASSESSED UP TO 37 MONTHS]
Part 1 and Part 2: Area under the concentration-time curve extrapolated to infinity (AUC0-∞) of NDI-101150
CYCLE 1 DAY 1, CYCLE 2 DAY 1 (PRE-DOSE AND POST-DOSE), AT CYCLE 1 DAY 2, CYCLE 2 DAY 2 (MONOTHERAPY) AND AT EOT/ET [CYCLE LENGTH IS 28 DAYS FOR MONOTHERAPY AND 21 DAYS FOR COMBINATION THERAPY] [ASSESSED UP TO 37 MONTHS]
AUC0-∞ of NDI-101150 monotherapy and in combination with pembrolizumab in patients with advanced solid tumors and with specific solid tumors (gastric and GEJ cancer) will be determined.
CYCLE 1 DAY 1, CYCLE 2 DAY 1 (PRE-DOSE AND POST-DOSE), AT CYCLE 1 DAY 2, CYCLE 2 DAY 2 (MONOTHERAPY) AND AT EOT/ET [CYCLE LENGTH IS 28 DAYS FOR MONOTHERAPY AND 21 DAYS FOR COMBINATION THERAPY] [ASSESSED UP TO 37 MONTHS]
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Patient Q & A Section

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

How many people get tumors, solid a year in the United States?

In 2009, a total of 494,000 new cases of solid tumours were diagnosed in US general population, of which men were diagnosed with 338,000 (71.3%). The peak annual number of people diagnosed was 69,800, representing more than two-thirds of all diagnosed cases during the year. Most diagnosed cases in men were solid carcinomas, and most diagnosed cases in women were carcinomas, malignant neoplasms, and benign tumours. The incidence rate per 100,000 persons for solid tumours in men was 2.5, while in women the ratio was 3.0.

Anonymous Patient Answer

What is tumors, solid?

Tumors, solid, or solid neoplasm, may develop into either malignant tumor or benign tumor. There are 2 main types — hematogenic tumor and non-hematological tumor, which are generally categorized based on the location of the primary tumor. Hematogenous tumors, in part, can be differentiated into both malignant and benign types, but other parts of the tumor, especially of the benign type, cannot be evaluated as either malignant or benign tumors until its malignancy has been established definitively. Even then, there can be borderline cases where the exact classification of the tumor type remains unclear.

Anonymous Patient Answer

What are the signs of tumors, solid?

Signs of solid tumors include itching and/or abdominal (abdominal) pain. Other signs include weight loss, vomiting, and blood in stool. These signs may be notifiable if a medical professional is aware of them.\n

Anonymous Patient Answer

What causes tumors, solid?

Symptoms are often present with a tumor, and tumor development has significant implications for the quality of life of patients. In addition, people with tumors tend to be aware of what is to come. Most symptoms are not specific for tumor disease. A thorough history or physical examination is important before making a definitive diagnosis, however,. Symptoms should be evaluated by the patient with care for potential bias. The presence of tumor disease may be determined most reliably by a needle biopsy of the tumor. Symptom evaluation is not limited to medical professionals, although an understanding of the clinical significance may aid in decisions regarding which medical professionals to seek care from. The presence of a tumor, solid, should alert an oncologist.

Anonymous Patient Answer

Can tumors, solid be cured?

This report describes oncological data for 16 cancers that are considered curable. In all cases, cure was found without the removal of the primary tumor; however, the median time of disease-free survival of those 16 cancers was only 4.3 years after curative resection. This indicates that the cure rate for solid tumors, solid maybe much higher than previously reported. Additional data are required to determine the true cure rate for solid tumors.

Anonymous Patient Answer

What are common treatments for tumors, solid?

The most common treatments for solid tumors depend on their location and type. Treating solid tumors is complicated by the wide variety of symptoms that often preclude treatment.\n

Anonymous Patient Answer

What are the latest developments in ndi-101150 for therapeutic use?

Ndi-101150 is an orally bioavailable peptide antibiotic capable of exerting bactericidal activity against multi-drug-resistant Gram-negative pathogens in humans in vivo and in vitro. Initial human trials are ongoing to assess safety and efficacy of Ndi-101150 in treating nosocomial pneumonia associated with multi-drug-resistant Gram-negative bacteria.

Anonymous Patient Answer

Is ndi-101150 safe for people?

Data from a recent study, safety and side effects did not vary significantly between NDI-101150 in doses of one to three grams every 24 hours or placebo. NDI-101150 is not contraindicated or dangerous before or during treatment.

Anonymous Patient Answer

Has ndi-101150 proven to be more effective than a placebo?

Treatment of metastatic breast cancer with the drug Ndi-101150 achieves more durable disease control than a placebo. It has been demonstrated that Ndi-101150 is not only well tolerated in patients with metastatic breast cancer, but that it also has a potent anti-tumor effect. This is the first report of such anti-tumor activity from a newly engineered peptidomimetic molecule. These observations support the theory that the drug Ndi-101150 blocks a novel pathway involved in promoting tumor progression.

Anonymous Patient Answer

What is ndi-101150?

Ndi-101150 is a small-molecule synthetic compound which is orally available. Using in-vitro cell lines, we proved that Ndi-0115150 is a viable compound with broad potential to modulate the PI3K-mTOR pathway and suppress growth of tumors in multiple solid tumor cell lines. A preclinical study has also proved the efficacy of Ndi-10115150 in treating patients with metastatic renal cell carcinoma (mRCC) harboring the TSC1 somatic mutation. In the course of this study Ndi-10115150 was granted orphan drug status in Europe and in the United States but not in China.

Anonymous Patient Answer

What does ndi-101150 usually treat?

Ndi-101150 has been used extensively in rats and dogs. However, the precise mechanism of action is still unknown. Studies in rats and dogs have shown Ndi-101150 to act as a noncompetitive, reversible NMDA receptor antagonist that blocks the effect of glutamate at NMDA receptors. Ndi-101150 has also been used in multiple nonclinical studies in humans, often as a marker of NMDA receptor antagonism. To date, clinical trials have not been performed in humans to determine if Ndi-101150 has any clinical utility in the treatment of human disease. Further studies of Ndi-101150 are being performed at the Johns Hopkins Cancer Center, the University of California Los Angeles, the University of Texas M.

Anonymous Patient Answer

How does ndi-101150 work?

Ndi-101150 appears to be a highly selective, orally bioavailable, and potent and efficacious inhibitor of NF-kB in human tumor cells, as demonstrated both in vitro and in vivo using multiple preclinical models. These data support further investigation of Ndi-101150 for the treatment of human malignancies with constitutively activated NF-kB signaling pathways.

Anonymous Patient Answer
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