What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy and immunotherapy, have a range of side effects. Chemotherapy can cause myelosuppression, leading to anemia, neutropenia, and thrombocytopenia, as well as gastrointestinal issues like nausea, vomiting, and diarrhea. Other side effects include fatigue, hair loss, and increased risk of infections. Immunotherapy, including agents like pembrolizumab, can lead to immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Specific side effects of NDI-101150 are not detailed, but it is important to monitor for both common and severe reactions when undergoing treatment.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors, particularly focusing on immunotherapy and targeted therapy. Pembrolizumab, an anti-PD-1 antibody, is approved for various solid tumors, including non-small cell lung cancer and melanoma. Atezolizumab, another immune checkpoint inhibitor targeting PD-L1, is approved for non-small cell lung cancer and renal cell carcinoma. Additionally, combination therapies such as pembrolizumab with chemotherapy have shown efficacy in treating advanced solid tumors. These approvals highlight the trend towards using immunotherapy and combination regimens in the management of solid tumors.

What other types of research exist?

Promising novel alternatives to NDI-101150 for solid tumor patients include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown efficacy in combination with chemotherapy for non-small-cell lung cancer and other solid tumors. 2) IdB 1016, a silybin-phosphatidylcholine complex, which is being evaluated for its antiangiogenic activity in ovarian cancer. 3) Atezolizumab, another immune checkpoint inhibitor, used in combination with chemotherapy for non-small-cell lung cancer. 4) Nivolumab, often combined with ipilimumab, showing promise in various solid tumors including renal cell carcinoma and gliomas. These alternatives are in various stages of clinical trials and have shown potential in treating solid tumors.

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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

Must not have

Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes, thromboembolic event within the past 3 months) or any important medical or psychiatric illness or abnormal laboratory finding

Central nervous system (CNS) malignant disease not previously treated, active leptomeningeal disease, uncontrolled symptomatic CNS involvement, or CNS malignant disease requiring steroid or other therapeutic intervention

Timeline

Screening 28 days

Treatment 6 months

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called NDI-101150, alone or with pembrolizumab, in adults with advanced cancers. It aims to find the safest dose and see how well it works. Pembrolizumab helps the immune system attack cancer cells and is used to treat various cancers.

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.

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.

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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe uncontrolled health conditions.

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I have a brain or spinal cord tumor that hasn't been treated, is spreading, or needs medication.

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I have a serious heart condition.

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I have had a transplant of an organ or bone marrow.

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I have had lung conditions like interstitial lung disease or pneumonia in the past 6 months.

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I stopped immunotherapy permanently due to a severe reaction.

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I have not had severe or life-threatening side effects from previous immunotherapy.

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I have another cancer that is growing and needs treatment.

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I cannot stop taking certain medications that affect how my body processes drugs.

Timeline

Screening ~ 28 days2 visits

Treatment ~ 6 months6 visits

Follow Up ~ 3 months3 visits

Screening ~ 28 days

Treatment ~ 6 months

Follow Up ~3 months

This trial's timeline: 28 days for screening, 6 months for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Frequency of dose-limiting toxicities (DLTs)

Part 2: Objective response rate (ORR)

Secondary study objectives

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 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~2810

0 / 12Eligibility criteria met

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.

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