Your session is about to expire
← Back to Search
Other
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 28 days
Treatment 6 months
Follow Up 3 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 belowSelect...
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.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 28 days2 visits
Treatment ~ 6 months6 visits
Follow Up ~ 3 months3 visits
Screening ~ 28 days
Treatment ~ 6 months
Follow Up ~3 months
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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
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
Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, while targeted therapies inhibit tumor growth by focusing on specific molecular targets such as proteins or genes.
Immunotherapy, such as pembrolizumab, boosts the body's immune system to recognize and destroy cancer cells. These mechanisms are vital for solid tumor patients as they provide diverse strategies to combat cancer, potentially improving treatment efficacy and allowing for more personalized approaches.
Innovative agents in multiple myeloma.Towards pathway-centric cancer therapies via pharmacogenomic profiling analysis of ERK signalling pathway.The challenge of targeted therapies for gastric cancer patients: the beginning of a long journey.
Innovative agents in multiple myeloma.Towards pathway-centric cancer therapies via pharmacogenomic profiling analysis of ERK signalling pathway.The challenge of targeted therapies for gastric cancer patients: the beginning of a long journey.
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Nimbus Saturn, Inc.Lead Sponsor
Anita Scheuber, MDStudy DirectorNimbus Saturn
Bhaskar Srivastava, MDStudy DirectorNimbus Saturn
2 Previous Clinical Trials
564 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe uncontrolled health conditions.I have a brain or spinal cord tumor that hasn't been treated, is spreading, or needs medication.I have a serious heart condition.My bone marrow, kidney, and liver are functioning well.I have had a transplant of an organ or bone marrow.My cancer can be measured by scans for the treatment study.I have had lung conditions like interstitial lung disease or pneumonia in the past 6 months.I stopped immunotherapy permanently due to a severe reaction.I agree to a tumor biopsy and have advanced cancer with no standard treatment options.My advanced cancer has no standard treatments left or didn't respond to them.I have not had severe or life-threatening side effects from previous immunotherapy.I had cancer treatment 2-6 weeks ago, depending on the type.I have another cancer that is growing and needs treatment.I am fully active or can carry out light work.It has been over 4 weeks since my last cancer treatment before starting NDI-101150.I have recovered from my last treatment, except for hair loss.I cannot stop taking certain medications that affect how my body processes drugs.
Research Study Groups:
This trial has the following groups:- Group 1: NDI-101150 (Monotherapy)
- Group 2: NDI-101150-Pembrolizumab (Combination therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 28 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger