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NTX-1088 for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas MD Anderson Cancer Center, Houston, TXCancer+4 MoreNTX-1088 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, NTX-1088, to see if it is safe and effective in treating people with advanced solid cancers. The trial will have two parts, with the first part testing different doses of the drug to see what is safe, and the second part testing the drug in combination with another drug, pembrolizumab, to see if it is effective.

Eligible Conditions
  • Locally Advanced Solid Tumors
  • Cancer
  • Solid Tumors
  • Metastatic Cancer
  • Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
SRF388
1
Dose escalation: COM902 monotherapy.
1
CTX-471

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Day 1 of dosing through 90 days after the last dose.

Day 21
Pharmacokinetics of NTX-1088
Day 90
Duration of Response (DoR)
Objective Response Rate (ORR)
Overall Survival (OS)
Progression Free Survival (PFS)
Day 21
Dose-limiting Toxicity (DLT)
Day 30
Dose-Finding
Frequency and Severity of Adverse Events (AE)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
SRF388
1
Dose escalation: COM902 monotherapy.
1
CTX-471

Side Effects for

Arm A (Phased Pembrolizumab Regimen)
71%Fatigue
43%Peripheral sensory neuropathy
38%Alopecia
38%Headache
33%Nausea
29%Dyspnea
29%Cough
29%Hypothyroidism
29%Pain
24%Rash maculo-papular
24%Constipation
19%Dyspepsia
19%Anorexia
19%Infusion related reaction
19%Abdominal pain
19%Bloating
19%Diarrhea
19%Pain in extremity
14%Sinusitis
14%Dehydration
14%Nasal congestion
14%Anemia
14%Hyperglycemia
14%Allergic rhinitis
14%Edema limbs
14%Hypokalemia
10%Restlessness
10%Pneumonitis
10%Thromboembolic event
10%Hoarseness
10%Pruritus
10%Hot flashes
10%Mucositis oral
10%Vomiting
10%Skin infection
10%Hyperthyroidism
10%Dry mouth
10%Localized edema
10%Fall
10%Alanine aminotransferase increased
10%Neutrophil count decreased
10%Lymphedema
10%Chills
10%Aspartate aminotransferase increased
10%Back pain
10%Dizziness
10%Flushing
10%Myalgia
5%Hypoglycemia
5%Fever
5%Malaise
5%Mucosal infection
5%Alkaline phosphatase increased
5%Recurrent laryngeal nerve palsy
5%Insomnia
5%Hypoxia
5%Periorbital edema
5%Hypertension
5%Lung infection
5%Sore throat
5%Urinary incontinence
5%Syncope
5%Urinary frequency
5%Urinary tract pain
5%Laryngeal hemorrhage
5%Postnasal drip
5%Skin hyperpigmentation
5%Hypotension
5%Atrial flutter
5%Dysgeusia
5%Respiratory failure
5%Nail infection
5%Upper respiratory infection
5%Bruising
5%Metabolism and nutrition disorders - Other, specify
5%Urinary urgency
5%Epistaxis
5%Sneezing
5%Infections and infestations - Other, specify
5%Lymph gland infection
5%Hyponatremia
5%Gastrointestinal disorders - Other
5%Urinary tract infection
5%Blood bilirubin increased
5%Creatinine increased
5%Platelet count decreased
5%Bone pain
5%Hepatic failure
5%Conjunctivitis
5%Eye disorders - Other, specify
5%Flashing lights
5%Non-cardiac chest pain
5%Hepatobiliary disorders - Other, specify
5%Allergic reaction
5%Hypocalcemia
5%Hypomagnesemia
5%Hypophosphatemia
5%Nail loss
5%Nail ridging
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT03018080) in the Arm A (Phased Pembrolizumab Regimen) ARM group. Side effects include: Fatigue with 71%, Peripheral sensory neuropathy with 43%, Alopecia with 38%, Headache with 38%, Nausea with 33%.

Trial Design

4 Treatment Groups

Part 2 - Dose Expansion (Combination Therapy)
1 of 4
Part 1 - Dose Escalation Phase (Monotherapy)
1 of 4
Part 2 - Dose Expansion (Monotherapy)
1 of 4
Part 1 - Dose Escalation Phase (Combination Therapy)
1 of 4

Experimental Treatment

90 Total Participants · 4 Treatment Groups

Primary Treatment: NTX-1088 · No Placebo Group · Phase 1

Part 2 - Dose Expansion (Combination Therapy)Experimental Group · 2 Interventions: NTX-1088, Pembrolizumab · Intervention Types: Drug, Drug
Part 1 - Dose Escalation Phase (Monotherapy)
Drug
Experimental Group · 1 Intervention: NTX-1088 · Intervention Types: Drug
Part 2 - Dose Expansion (Monotherapy)
Drug
Experimental Group · 1 Intervention: NTX-1088 · Intervention Types: Drug
Part 1 - Dose Escalation Phase (Combination Therapy)Experimental Group · 2 Interventions: NTX-1088, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2200

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 of dosing through 90 days after the last dose.

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,707 Previous Clinical Trials
4,964,116 Total Patients Enrolled
Nectin Therapeutics LtdLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 13 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a disease that has not responded to standard treatments or there are no standard treatments available.
References

Frequently Asked Questions

Are applications being accepted for this trial presently?

"As gleaned from clinicaltrials.gov, this trial is no longer accepting patients; the initial post date was June 1st 2022 while its last edit occurred on May 12th 2022. Nonetheless, there are 3,700 other trials actively recruiting right now." - Anonymous Online Contributor

Unverified Answer

What degree of safety has been demonstrated for NTX-1088?

"Our experts at Power have calculated that NTX-1088's safety is rated a 1 on the scale of 1 to 3 due to it being in its initial stage of clinical trial testing and having limited supporting evidence." - Anonymous Online Contributor

Unverified Answer

What are the anticipated results of this research project?

"The primary endpoint of this investigation, which is measured over a period extending from the Screening to 30 days after last dose-Finding, concerns Dose. The secondary objectives encompass Objective Response Rate (ORR) according to RECIST v1.1., Duration of Response (DoR), and Progression Free Survival (PFS). DoR refers to the time between when criteria for PR or CR are first met until measurement criteria for progressive disease have been fulfilled, while PFS evaluates the timeline starting at initiation of study therapy up till either progression or death." - Anonymous Online Contributor

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

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