NPX267 for Cancer

Recruiting at 9 trial locations

Overseen By Lauren Doherty, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NextPoint Therapeutics, Inc.

Must not be taking: Immunosuppressants

Disqualifiers: Brain metastases, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

131 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, NPX267, to determine its safety and manageability for people with certain types of cancer. NPX267 aims to help the immune system fight cancer by blocking a specific protein that tumors use to evade immune cells. The trial seeks participants whose cancer has returned or spread after standard treatments, specifically those with lung, kidney, or breast cancer. Participants will receive the drug through an IV every three weeks, provided their cancer does not worsen. As a Phase 1 trial, this research focuses on understanding how NPX267 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that NPX267 is likely to be safe for humans?

Research shows that NPX267 remains in the early stages of human testing, so complete safety information is not yet available. As a Phase 1 trial, the primary goal is to assess the safety and tolerability of NPX267 for patients. These studies are typically small, with participants closely monitored to detect any side effects early.

Since NPX267 has not been approved for other treatments, information about its safety is limited. Participants in the trial will receive doses every three weeks, with doctors closely monitoring them for side effects to determine the best dose and manage any issues.

Overall, while NPX267 shows promise in targeting certain cancer cells, its safety in humans is still under careful study. Prospective participants can expect thorough monitoring to ensure their safety as researchers gather more data. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard chemotherapy and immunotherapy treatments for cancer, NPX267 represents an innovative approach by targeting a novel molecular pathway specific to cancer cells. This unique mechanism of action could potentially lead to fewer side effects and improved effectiveness since it aims at cancer cells directly without affecting healthy cells. Researchers are excited about NPX267 because it could offer a more precise and potentially less toxic alternative to existing treatments, which often come with significant side effects.

What evidence suggests that NPX267 might be an effective treatment for cancer?

Research has shown that targeting a specific part of cancer cells, the B7-H7 receptor, might help the immune system combat cancer. NPX267, the drug participants in this trial will receive, is designed for this purpose. Similar drugs, such as bevacizumab, have improved outcomes in lung cancer when combined with chemotherapy. This suggests that NPX267 could also be effective for cancers with the B7-H7 receptor, including some lung cancers. Early results indicate that NPX267 might prevent cancer cells from evading the immune system, making it a promising new treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Leena Gandhi, MD, PhD

Principal Investigator

NextPoint

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced cancers, like lung or breast cancer, that no longer respond to standard treatments. They must be fairly active (ECOG status 0 or 1), have normal organ function, and agree to use effective birth control. People can't join if they're on high-dose steroids for autoimmune diseases, have unstable brain tumors, severe lingering side effects from past cancer treatments (except hair loss or long-term nerve pain/skin color changes), or a history of serious immune-related lung/intestine problems.

Inclusion Criteria

Willing to use highly effective contraceptive measures throughout the trial

My bone marrow, kidney, and liver are functioning normally.

I am fully active or can carry out light work.

Exclusion Criteria

My brain metastases are stable and not causing symptoms.

I have had severe lung or colon inflammation due to immune system reactions.

I take more than 10 mg of prednisone daily for an autoimmune disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive varying doses of NPX267 to determine the appropriate dose for further study

9 weeks

3 visits (in-person) every 3 weeks

Dose Expansion

Participants receive the determined dose of NPX267 to evaluate its effect on tumors

9 weeks

3 visits (in-person) every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Tumor imaging every 9 weeks

Long-term Follow-up

Participants are monitored for overall survival and immunogenicity

30 months

What Are the Treatments Tested in This Trial?

Interventions

• NPX267

Trial Overview NPX267 is being tested in this study. It's an antibody drug given by IV every three weeks aimed at helping the body's immune system recognize and fight cancer cells expressing HHLA2 protein. The study will determine the right dose and assess how patients handle the treatment regarding safety and tolerability.

How Is the Trial Designed?

Group I: NPX267 Treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

NextPoint Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

280+

Published Research Related to This Trial

In a phase III trial involving 1,043 patients with advanced nonsquamous non-small-cell lung cancer, the combination of bevacizumab with cisplatin and gemcitabine significantly improved progression-free survival (PFS) compared to placebo, with hazard ratios of 0.75 for low-dose and 0.82 for high-dose bevacizumab.

The treatment also resulted in higher objective response rates (34.1% for low-dose and 30.4% for high-dose bevacizumab) compared to placebo (20.1%), while maintaining a similar incidence of serious adverse events across all treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. Reck, M., von Pawel, J., Zatloukal, P., et al.[2022]

In a phase 3 trial involving 938 patients with advanced non-small-cell lung cancer (NSCLC), the addition of cetuximab to pemetrexed chemotherapy did not significantly improve progression-free survival compared to pemetrexed alone, with median survival times of 2.9 months versus 2.8 months, respectively.

Patients receiving cetuximab experienced a higher rate of serious adverse events (41% vs. 29% in the pemetrexed-only group), leading to a recommendation against the use of cetuximab in combination with chemotherapy for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel or pemetrexed with or without cetuximab in recurrent or progressive non-small-cell lung cancer after platinum-based therapy: a phase 3, open-label, randomised trial. Kim, ES., Neubauer, M., Cohn, A., et al.[2020]

Cetuximab, an EGFR antagonist, enhances the effectiveness of radiotherapy in treating advanced head and neck cancer without increasing the usual toxicity associated with radiation or chemotherapy.

The presence of EGFR in nearly all head and neck carcinoma cases presents a significant therapeutic opportunity, as its expression is linked to poorer outcomes in patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cetuximab in squamous cell head and neck carcinomas. Gebbia, V., Giuliani, F., Valori, VM., et al.[2020]

The new chemotherapy regimen combining docetaxel, cisplatin, and cetuximab (B-CRT) for treating locally advanced head and neck squamous cell carcinoma resulted in severe neutropenia in 56% of patients, indicating significant safety concerns.

Due to the high incidence of adverse events, particularly neutropenia and leukopenia, the study was terminated early, and it remains unclear if B-CRT is as effective as the standard TPF-CRT regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of concurrent bio-chemoradiotherapy using docetaxel, cisplatin, and cetuximab for locally advanced head and neck squamous cell carcinoma. Nishimura, G., Taguchi, T., Takahashi, M., et al.[2018]

Bevacizumab, an anti-VEGF monoclonal antibody, has been shown to improve treatment outcomes when combined with platinum-based chemotherapy in patients with advanced nonsquamous non-small cell lung cancer (NSCLC), as demonstrated in two phase III randomized trials.

This combination therapy represents a significant advancement in NSCLC treatment, marking the first evidence of enhanced efficacy when integrating targeted therapies with traditional chemotherapy, and future studies will explore its use alongside other targeted agents like erlotinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of bevacizumab in the treatment of non-small cell lung cancer: current indications and future developments. Gridelli, C., Maione, P., Rossi, A., et al.[2015]

Citations

1. withpower.com withpower.com/trial/phase-1-neoplasms-6-2023-7c19a

NPX267 for Cancer · Info for Participants Research shows that bevacizumab, a component similar to NPX267, improves outcomes in non-small cell lung cancer when combined with chemotherapy. Additionally, ...

2. npcf.us npcf.us/clinical-trials/a-study-of-npx267-for-subjects-with-solid-tumors-known-to-express-hhla2-b7-h7/

A Study Of NPX267 For Subjects With Solid Tumors Known To ... The goal of this clinical trial is to learn whether NPX267 is safe and tolerable in patients whose cancers are known to express HHLA2 including epidermal growth ...

3. trials-api.montefioreeinstein.org trials-api.montefioreeinstein.org/index.php/node/395561

A Study of NPX267 for Subjects With Solid Tumors Known to ... The goal of this clinical trial is to learn whether NPX267 is safe and tolerable in patients whose cancers are known to express HHLA2 including epidermal growth ...

4. cancer.gov cancer.gov/clinicaltrials/NCI-2023-06569

A Study of NPX267 for Subjects With Solid Tumors Known ... The goal of this clinical trial is to learn whether NPX267 is safe and tolerable in patients whose cancers are known to express HHLA2 including epidermal growth ...

5. clinicaltrials.phentrials.com clinicaltrials.phentrials.com/clinical-trials/a-study-of-npx267-for-subjects-with-solid-tumors-known-to-express-hhla2-b7-h7/

A Study of NPX267 for Subjects With Solid Tumors Known ... The goal of this clinical trial is to learn whether NPX267 is safe and tolerable in patients whose cancers are known to express HHLA2 including epidermal growth ...

6. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A723.full.pdf

633 A Phase 1a/1b, dose-escalation/ ... NPX267 is a monoclonal antibody. (IgG4) directed against KIR3DL3 which blocks the interaction of KIR3DL3 with HHLA2 to enhance NK cell-mediated tumor cell ...

7. firstwordpharma.com firstwordpharma.com/story/5771828

NextPoint Therapeutics Announces First Patient Dosed in ... “This study will provide important data on the therapeutic activity of NPX267 as well as the mechanism of HHLA2-mediated immunosuppression ...

8. synapse.patsnap.com synapse.patsnap.com/drug/fea08fbba03d268b1088765ee0a77e01

NPX267 - Drug Targets, Indications, Patents NPX267: a KIR3DL3 inhibitors Drug, Initially developed by Nextpoint Therapeutics, Inc., Now, its global highest R&D status is Suspended, Mechanism: KIR3DL3 ...