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Monoclonal Antibodies
NTX-1088 + Pembrolizumab for Cancer
Phase 1
Recruiting
Research Sponsored by Nectin Therapeutics Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate baseline hematopoietic, kidney, and liver function
At least 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of dosing through 90 days after the last dose.
Awards & highlights
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.
Who is the study for?
Adults with advanced solid cancers that express PVR, who have tried standard treatments without success or for whom no standard treatment is available. They must be in good physical condition (ECOG ≤1), not pregnant or breastfeeding, agree to use contraception, and have tumors measurable by RECIST 1.1.Check my eligibility
What is being tested?
The trial studies NTX-1088 alone and combined with Pembrolizumab in patients with advanced solid malignancies. It's a two-part study: first testing different doses of NTX-1088 (dose escalation) and then expanding the trial to more patients at the chosen dose.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to both drugs' action on cancer cells but also possibly affecting normal cells, as well as typical infusion-related responses such as fever or chills.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood, kidney, and liver tests are within normal ranges.
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I am 18 years old or older.
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I am fully active and can carry on all pre-disease activities without restriction.
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My condition did not improve with standard treatments, or there are none that would help, or I chose not to undergo such treatments.
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My cancer has been confirmed to express PVR.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 of dosing through 90 days after the last dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of dosing through 90 days after the last dose.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-Finding
Dose-limiting Toxicity (DLT)
Frequency and Severity of Adverse Events (AE)
Secondary outcome measures
Duration of Response (DoR)
Objective Response Rate (ORR)
Overall Survival (OS)
+2 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%
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
4Treatment groups
Experimental Treatment
Group I: Part 2 - Dose Expansion (Monotherapy)Experimental Treatment1 Intervention
NTX-1088 administered at the RP2D as a 60-minute IV infusion as a monotherapy.
Group II: Part 2 - Dose Expansion (Combination Therapy)Experimental Treatment2 Interventions
NTX-1088 administered at the RP2D as a 60-minute IV infusion in combination with pembrolizumab at the standard labeled dose.
Group III: Part 1 - Dose Escalation Phase (Monotherapy)Experimental Treatment1 Intervention
NTX-1088 administered as a 60-minute IV infusion at escalating doses as a monotherapy. NTX-1088 will be administered on Day 1 of a 21-day cycle.
Group IV: Part 1 - Dose Escalation Phase (Combination Therapy)Experimental Treatment2 Interventions
NTX-1088 administered as a 60-minute IV infusion in escalating doses in combination with pembrolizumab. NTX-1088 will be administered on Day 1 of a 21-day cycle.
Pembrolizumab will be administered as a 30-minute IV infusion, within 2 hours prior to NTX-1088 administration, at a dose of 200 mg on Day 1 of every 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Nectin Therapeutics LtdLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,059,845 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain metastases are stable after treatment.My blood, kidney, and liver tests are within normal ranges.I had radiotherapy less than 2 weeks ago.I am 18 years old or older.I have not received a live vaccine in the last 30 days.I have a health condition that makes cancer treatment too risky for me.I have fully recovered from any major surgery before starting the study.I have a hormone disorder that is not well-managed.I have not had any other cancer that is getting worse or needed treatment in the last 3 years.I stopped a cancer immunotherapy because of a severe side effect.I've had lung radiation of more than 30 Gray in the last 6 months.I have previously been treated with NTX-1088 or a similar experimental drug.I have or had lung inflammation needing steroids.I do not have any illnesses that would stop me from following the study's requirements.I am fully active and can carry on all pre-disease activities without restriction.I've had a severe allergic reaction to pembrolizumab or its ingredients.I have a serious heart condition.I have recovered from side effects of previous treatments to my normal or mild condition.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I need oxygen support to breathe.I have a serious lung condition that is not under control.My condition did not improve with standard treatments, or there are none that would help, or I chose not to undergo such treatments.I can provide a recent biopsy sample of my tumor.I am currently undergoing treatment with cancer-fighting medications.I don't have any health issues that could affect the study's results.I can have blood drawn without difficulty.I have a history of Hepatitis B or an active Hepatitis C infection.I have received a transplant from another person.I agree to follow contraceptive advice during and for 4 months after the study.My cancer has been confirmed to express PVR.I am not pregnant or breastfeeding and agree to use birth control during and for 4 months after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 - Dose Escalation Phase (Monotherapy)
- Group 2: Part 1 - Dose Escalation Phase (Combination Therapy)
- Group 3: Part 2 - Dose Expansion (Monotherapy)
- Group 4: Part 2 - Dose Expansion (Combination Therapy)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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