What side effects are associated with this type of intervention?

Common side effects of cancer treatments that modulate the immune response or directly target cancer cells, such as monoclonal antibodies and immune checkpoint inhibitors, include immune-related adverse events like pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Other frequent side effects are fatigue, nausea, diarrhea, and infusion-related reactions. Severe side effects can involve organ-specific inflammation and autoimmune conditions, necessitating immunosuppressive therapy.

What prior FDA approvals exist?

The FDA has approved several treatments that modulate the immune response or directly target cancer cells. Pembrolizumab and nivolumab are immune checkpoint inhibitors that target PD-1, enhancing the body's immune response against cancer cells. Ipilimumab, another immune checkpoint inhibitor, targets CTLA-4. Additionally, CAR T-cell therapies, such as tisagenlecleucel, genetically modify a patient's T cells to target specific cancer antigens. These treatments, like NTX-1088, aim to harness and enhance the immune system's ability to fight cancer.

What other types of research exist?

<ol> <li>CXCR4 inhibitors (e.g., AMD3100) - These have shown synergy with cytotoxic chemotherapy in gliomas, leading to increased apoptosis and decreased proliferation.</li> <li></li> </ol> Rapamycin and MK-2206 - This combination targets mTOR and Akt pathways and has shown promise in treating Tuberous Sclerosis Complex. 3. DMP 840 - A bis-naphthalimide antitumor agent with selective activity against human tumor xenografts, currently in Phase II trials. 4. F 11782 - A dual catalytic inhibitor of topoisomerases I and II, showing significant antitumor activity in various human tumor xenografts. 5. SU11248 (Sunitinib) - A FLT3 tyrosine kinase inhibitor with potent activity in vitro and in vivo, particularly in FLT3-ITD models. 6. VS-5584 - A PI3K-mTOR dual inhibitor that has shown efficacy in melanoma models, with enhanced activity when combined with Bcl-xL/Bcl-2 inhibitors.

← Back to Search

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

Must not have

Uncontrolled endocrine disorder

Additional active malignancy progressing or requiring active treatment within the past 3 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of dosing through 90 days after the last dose.

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests NTX-1088, alone or with pembrolizumab, in patients with advanced solid cancers. NTX-1088 helps the immune system find and attack cancer cells, while pembrolizumab boosts the immune system's ability to fight cancer.

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.

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.

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 below

Select...

My blood, kidney, and liver tests are within normal ranges.

Select...

I am 18 years old or older.

Select...

I am fully active and can carry on all pre-disease activities without restriction.

Select...

My condition did not improve with standard treatments, or there are none that would help, or I chose not to undergo such treatments.

Select...

My cancer has been confirmed to express PVR.

Exclusion Criteria

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

Select...

I have a hormone disorder that is not well-managed.

Select...

I have not had any other cancer that is getting worse or needed treatment in the last 3 years.

Select...

I stopped a cancer immunotherapy because of a severe side effect.

Select...

I've had lung radiation of more than 30 Gray in the last 6 months.

Select...

I have previously been treated with NTX-1088 or a similar experimental drug.

Select...

I have or had lung inflammation needing steroids.

Select...

I've had a severe allergic reaction to pembrolizumab or its ingredients.

Select...

I have a serious heart condition.

Select...

I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.

Select...

I need oxygen support to breathe.

Select...

I have a serious lung condition that is not under control.

Select...

I am currently undergoing treatment with cancer-fighting medications.

Select...

I have a history of Hepatitis B or an active Hepatitis C infection.

Select...

I have received a transplant from another person.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of dosing through 90 days after the last dose. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose-Finding

Dose-limiting Toxicity (DLT)

Frequency and Severity of Adverse Events (AE)

Secondary study objectives

Duration of Response (DoR)

Objective Response Rate (ORR)

Overall Survival (OS)

+2 more

Awards & Highlights

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.

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

0 / 19Eligibility 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 cancer treatments include immune-based therapies and targeted therapies. Immune-based therapies, like immune checkpoint inhibitors, enhance the body's immune response by blocking proteins that prevent immune cells from attacking cancer cells. Targeted therapies involve drugs that specifically inhibit molecules essential for cancer cell growth and survival. These approaches are important for cancer patients as they provide more personalized and potentially more effective treatment options with fewer side effects compared to traditional chemotherapy.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Propelling Immunotherapy Combinations Into the Clinic.