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NDI-101150 + Pembrolizumab for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Nimbus Saturn, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Dose Escalation Phase Only (Dose Escalation, Monotherapy and Combination Therapy): Histologically or cytologically confirmed advanced or metastatic solid tumors for whom no standard therapies are available or refractory to standard therapy
For Dose Expansion Phase (Dose Expansion, Monotherapy and Combination Therapy): Willing to consent to required tumor biopsy(ies). Histologically or cytologically confirmed advanced or metastatic G/GEJ, NSCLC or RCC for which no standard therapy is available or are refractory to standard therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 37 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see what dose is safe and how well it works.

Who is the study for?
This trial is for adults with advanced solid tumors who have a life expectancy of at least 12 weeks, are willing to undergo tumor biopsies if needed, and have recovered from previous therapies. They should not have had cancer treatment in the last 4 weeks and must be in good physical condition (ECOG status 0-1). People with recent malignancies, severe allergies to monoclonal antibodies, untreated brain cancers, significant heart or lung conditions, or uncontrolled medical issues cannot join.Check my eligibility
What is being tested?
The study aims to find the safest high dose (MTD) and best Phase 2 dose (RP2D) of NDI-101150 alone or combined with pembrolizumab. It will look into how these treatments affect patients' bodies (pharmacokinetics), their action on tumors (pharmacodynamics), safety profiles, and initial effectiveness against solid tumors.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs including lungs (pneumonitis), infusion-related reactions similar to allergic responses during drug administration, fatigue due to treatment burden on the body's resources, potential blood disorders affecting cell counts or clotting ability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer has no standard treatments left or didn't respond to them.
Select...
I agree to a tumor biopsy and have advanced cancer with no standard treatment options.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 37 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 37 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
Part 1: Frequency of dose-limiting toxicities (DLTs)
Part 2: Objective response rate (ORR)
Secondary outcome measures
Part 1 and Part 2: Area under the concentration-time curve extrapolated to infinity (AUC0-∞) of NDI-101150
Part 1 and Part 2: Area under the concentration-time curve from time zero to the last observable concentration (AUC0-t) of NDI-101150
Part 1 and Part 2: Duration of response (DOR)
+7 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

2Treatment groups
Experimental Treatment
Group I: NDI-101150-Pembrolizumab (Combination therapy)Experimental Treatment2 Interventions
Patients in escalation and expansion phase, will receive NDI-101150 capsules orally once daily continuously in 3-week cycles (21 days), along with pembrolizumab via intravenous (IV) infusion at a dose of 200 mg every 3 weeks.
Group II: NDI-101150 (Monotherapy)Experimental Treatment1 Intervention
Patients in escalation and expansion, will receive NDI-101150 capsules orally once daily continuously in 4-week cycles (28 days).
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?

Nimbus Saturn, Inc.Lead Sponsor
Bhaskar Srivastava, MDStudy DirectorNimbus Saturn
2 Previous Clinical Trials
646 Total Patients Enrolled
Dan Rudin, MDStudy DirectorNimbus Saturn
1 Previous Clinical Trials
2 Total Patients Enrolled

Media Library

NDI-101150 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05128487 — Phase 1 & 2
Solid Tumors Research Study Groups: NDI-101150 (Monotherapy), NDI-101150-Pembrolizumab (Combination therapy)
Solid Tumors Clinical Trial 2023: NDI-101150 Highlights & Side Effects. Trial Name: NCT05128487 — Phase 1 & 2
NDI-101150 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05128487 — Phase 1 & 2

Frequently Asked Questions

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

How many individuals are participating in this research project?

"The trial is currently ongoing and recruiting participants, with the most recent update being on 10/31/2022. The study was initially posted on 11/5/2021. 106 patients are needed for the completion of the trial at 5 different locations."

Answered by AI

What are the primary indications for NDI-101150?

"NDI-101150 is an effective treatment for unresectable melanoma, microsatellite instability high, and other malignant neoplasms."

Answered by AI

Are there a lot of places in town where this research is taking place?

"Patients can be enrolled at Georgetown University, Ocala Oncology Center, Honor Health Research Institute, and 5 other locations."

Answered by AI

What other research studies have looked at the effects of NDI-101150?

"Currently, there are 1000 ongoing clinical trials investigating NDI-101150 with 122 of them being in Phase 3. Some of the NDI-101150 trials are based in Houston, Texas; however, there are 36030 research locations worldwide for this drug."

Answered by AI

What goals does this research seek to achieve?

"The goal of this study, which will be assessed over a period of 34 months, is to evaluate the frequency of dose-limiting toxicities (DLTs). Secondary objectives include assessing the duration of response (DOR) and volume and clearance of NDI-101150. DOR is defined as the time from the date of first response to the date of confirmed progression, according to RECIST v1.1 as assessed by the Investigator. Vz/F and CL/F are defined as volume and clearance of NDI-101150 monotherapy and in combination with pembrolizumab in patients with advanced"

Answered by AI

Are people with the target illness able to join this clinical trial currently?

"Yes, this clinical trial is looking for volunteers and the relevant information can be found on clinicaltrials.gov. The listing was created on November 5th, 2021 and last updated a month ago on October 31st, 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of NDI 1150-101 in Patients With Solid Tumors
2021. "A Study of NDI 1150-101 in Patients With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05128487.
~13 spots leftby Sep 2024
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