NPX267 for Cancer

Recruiting at9 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: NextPoint Therapeutics, Inc.

Must not be taking: Immunosuppressants

Disqualifiers: Brain metastases, Autoimmune disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests NPX267, an antibody drug that helps the immune system fight cancer by targeting a specific marker on cancer cells. It focuses on patients with certain cancers, including a type of lung cancer, to find a safe and effective dose. The study will monitor side effects and check how well the drug works against tumors.

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.

What data supports the effectiveness of the drug NPX267 for cancer?

Research shows that bevacizumab, a component similar to NPX267, improves outcomes in non-small cell lung cancer when combined with chemotherapy. Additionally, cetuximab, another component, enhances the effects of radiotherapy in head and neck cancers. ^{1 2 3 4 5}

Research Team

Leena Gandhi, MD, PhD

Principal Investigator

NextPoint

Eligibility Criteria

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 don't have lasting side effects from cancer treatment, except for hair loss, long-term nerve damage, or skin color changes.

Trial Timeline

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

Treatment Details

Interventions

• NPX267 (Monoclonal Antibodies)

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.

Participant Groups

Group I: NPX267 Treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

NextPoint Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

280+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The role of bevacizumab in the treatment of non-small cell lung cancer: current indications and future developments. [2015]

2. United States 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. [2022]

3. Germany 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. [2018]

4. England 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. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Cetuximab in squamous cell head and neck carcinomas. [2020]