PHN-010 for Cancer

Not currently recruiting at 7 trial locations

Overseen By Myles Clancy

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pheon Therapeutics

Must not be taking: Topoisomerase inhibitors

Disqualifiers: Unstable CNS metastasis, Infections, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PHN-010, designed to target and destroy cancer cells. It is intended for individuals with advanced solid tumors, including certain types of colorectal, ovarian, endometrial, cervical, or lung cancer. The primary goal is to determine the safety and effectiveness of PHN-010 against these cancers. Suitable candidates have already tried at least one unsuccessful cancer treatment and have a form of cancer that doctors can measure. Participants will receive PHN-010 through an intravenous (IV) drip. As a Phase 1 trial, this research focuses on understanding how PHN-010 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 does not specify if you need to stop taking your current medications, but you cannot have received systemic anti-cancer therapy within a certain period before starting the study drug. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that PHN-010 is likely to be safe for humans?

Research shows that PHN-010 has promising safety results from early animal tests. These studies help researchers understand how the drug might work in humans. Tests found that animals similar to humans tolerated PHN-010 well, indicating potential safety for people.

This current study marks the first human trial of PHN-010. The main focus is on safety, with close monitoring of any side effects. Although human data is not yet available, the transition from animal to human trials indicates researchers' confidence in its safety.

In summary, PHN-010 has been safe in animal studies, and this trial will assess its safety in humans. Participants will be closely monitored to address any issues promptly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

PHN-010 is unique because it is administered intravenously and may offer a new mechanism of action compared to traditional cancer treatments like chemotherapy, radiation, or targeted therapies. Researchers are excited about PHN-010 because it has the potential to target cancer cells more precisely, possibly leading to fewer side effects and improved outcomes. This approach could revolutionize the way we treat cancer by offering a more efficient and potentially less toxic treatment option.

What evidence suggests that PHN-010 might be an effective treatment for cancer?

Research shows that PHN-010 is a new treatment combining an antibody with a powerful drug to fight cancer. The antibody locates and attaches to cancer cells, enabling direct drug delivery to the tumor. Although PHN-010 is new, early studies suggest it can effectively target certain proteins in many solid tumors. This targeted approach is promising, potentially leading to better results with fewer side effects than traditional chemotherapy. However, as PHN-010 is being tested in humans for the first time in this trial, more information is needed to confirm its effectiveness against cancer. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced solid tumors, including lung, endometrial, ovarian, cervical, and colon cancers. Participants must have had at least one prior therapy and no available standard treatment options or be intolerant to them. They should have a performance status of 0 or 1 (able to carry out daily activities), measurable disease, adequate organ function, and a tumor tissue sample.

Inclusion Criteria

My lung cancer is advanced and has spread to other parts.

I am fully active or can carry out light work.

My organs are working well.

Exclusion Criteria

My cancer has spread to my brain and is not stable.

I haven't taken cancer drugs within the last 21 days or five half-lives, whichever is shorter.

I have not had major surgery in the last 28 days or still have side effects from it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PHN-010 intravenously to evaluate safety, tolerability, and anti-tumor activity

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PHN-010

Trial Overview PHN-010 is being tested in this study. It's an antibody-drug conjugate aimed at treating various advanced solid tumors. The trial will assess its safety, how well it's tolerated by patients' bodies, its effectiveness against cancer cells (anti-tumor activity), immune response (immunogenicity), distribution within the body (pharmacokinetics), and effect on the body's biological processes (pharmacodynamics).

How Is the Trial Designed?

Group I: Phase 1a and Phase 1b Experimental Treatment 1 Intervention

PHN-010 is administered intravenously.

Who Is Running the Clinical Trial?

Pheon Therapeutics

Lead Sponsor

Trials

1

Recruited

270+

Published Research Related to This Trial

The pHLIP-αKu80(γ) conjugate effectively targets acidic cancer cells, selectively reducing the expression of the DNA repair factor KU80, which enhances the effectiveness of radiation therapy without harming healthy tissue.

In mouse models, pHLIP-αKu80(γ) significantly reduced tumor growth when combined with radiation treatment, and it showed no acute toxicity, indicating its potential as a safe and effective radiosensitizing agent for cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ku80-Targeted pH-Sensitive Peptide-PNA Conjugates Are Tumor Selective and Sensitize Cancer Cells to Ionizing Radiation. Kaplan, AR., Pham, H., Liu, Y., et al.[2021]

Recent studies reveal that the intracellular pH of cancer cells is often neutral or mildly alkaline, contrary to the previous belief that both intracellular and extracellular pH in tumors are acidic.

The review discusses new treatment strategies that aim to manipulate both intracellular and extracellular pH levels in cancer cells, suggesting that nanoparticle-based approaches could be effective in enhancing cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manipulating extracellular tumour pH: an effective target for cancer therapy. Hao, G., Xu, ZP., Li, L.[2022]

The HN-1 peptide has been identified as a promising delivery vector for anticancer drugs, effectively targeting and infiltrating solid tumors like head and neck squamous cell carcinoma (HNSCC) by binding to the discoidin-domain receptor 1 (DDR1), which is overexpressed in these cancers.

The study provides insights into the mechanism of HN-1's action, showing that it is internalized through energy-dependent clathrin-mediated endocytosis, suggesting that targeting DDR1 could enhance the efficacy of treatments for metastatic cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor specifically internalizing peptide 'HN-1': Targeting the putative receptor retinoblastoma-regulated discoidin domain receptor 1 involved in metastasis. Hong, FU., Castro, M., Linse, K.[2022]

pHLIP(®) peptides effectively target acidic tumors, allowing for the delivery of imaging and therapeutic agents, which is crucial for cancer treatment.

Fluorescently labeled pHLIP(®) variants can identify small metastatic lesions in the lungs, demonstrating their potential for precise tumor localization and improved cancer diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Study of Tumor Targeting and Biodistribution of pH (Low) Insertion Peptides (pHLIP(®) Peptides) Conjugated with Different Fluorescent Dyes. Adochite, RC., Moshnikova, A., Golijanin, J., et al.[2019]

pH-low insertion peptides (pHLIPs) can enhance the delivery of cancer treatments by selectively targeting tumors based on their acidic environment, which is common in hypoxic tumors.

This review discusses the versatility of pHLIPs in delivering various therapeutic agents, including small molecule inhibitors and nanoparticles, potentially improving treatment efficacy while reducing toxicity to healthy tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting the Hypoxic and Acidic Tumor Microenvironment with pH-Sensitive Peptides. Dharmaratne, NU., Kaplan, AR., Glazer, PM.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06457997

A Study of PHN-010 in Patients With Advanced Solid Tumors The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12046379/

Monotherapy and combination therapy using antibody ... Platinum-resistant ovarian cancer (PROC) is a significant clinical challenge due to the limited number of treatment options and poor outcomes.

3. synapse.patsnap.com synapse.patsnap.com/drug/d038b3b8cf7640f3823fc9353926ef08

PHN-010 - Drug Targets, Indications, Patents First-in-Human, Phase 1b Study of PHN-010, an Antibody Drug Conjugate, in Patients with Advanced Solid Tumors. 100 Clinical Results associated with PHN-010.

4. ctv.veeva.com ctv.veeva.com/study/a-study-of-phn-010-in-patients-with-advanced-solid-tumors

A Study of PHN-010 in Patients With Advanced Solid Tumors This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010.

5. adcreview.com adcreview.com/business-economics/pheon-therapeutics-a-next-generation-adc-developer/

Pheon Therapeutics - a Next-generation ADC Developer Pheon's lead program, PHN-010, an ADC targeted to an internalizable single-pass transmembrane protein which is highly over-expressed in multiple ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06457997

A Study of PHN-010 in Patients With Advanced Solid Tumors This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel ...

7. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2024-0496.html

First-in-human, phase 1b study of PHN-010, an antibody ... This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel ...

8. pheontx.com pheontx.com/science-technology/

Science & Technology Lead program has demonstrated robust preclinical data including in vivo efficacy, NHP safety, and extensive expression profiling in tumors and healthy tissue.

9. fredhutch.org fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15599.an-expanded-access-treatment-plan-for-continuation-of-treatment-with-phn-010-an-investigational-antibody-drug-conjugate-following-participation-in-a.html

Clinical Trial Details An Expanded Access Treatment Plan for Continuation of Treatment with PHN 010, an Investigational Antibody Drug Conjugate, Following ...

10. withpower.com withpower.com/trial/phase-1-endometrial-neoplasms-6-2024-2fd54

PHN-010 for Cancer · Info for Participants This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel ...