First-in-Human, Phase 1 Study of PHN-012, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors

First-in-human trial of PHN-012, a new cancer drug, for advanced solid tumors.

NCT: NCT07127874 · Status: RECRUITING · Phase: Phase 1 · Sponsor: Pheon Therapeutics · Started: 2025-09-23 · Est. Completion: 2028-05

Plain English Summary

A Study of PHN-012 in Patients With Advanced Solid Tumors is a Phase 1 clinical trial sponsored by Pheon Therapeutics studying Colon Cancer, Pancreatic Cancer, Lung Cancer (NSCLC), Advanced Cancer, Advanced Solid Tumors. This trial tests a new drug called PHN-012, which is a type of targeted therapy for cancer. It is for adults with advanced or spreading colon, lung (NSCLC), or pancreatic cancer that has not responded to previous treatments. Participants will receive the study drug, and their health will be closely monitored. There are no alternative treatments offered within this trial; standard care options should be discussed with a doctor. The trial aims to enroll 165 participants.

Official Summary

This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-012, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with specific types of advanced colon, non-small cell lung, or pancreatic cancer. Must have had at least one prior cancer treatment and their cancer has progressed. Must have measurable disease and be in good general health (ECOG 0-1). Cannot have received certain prior treatments with similar drugs or have unstable brain metastases. This trial is studying Colon Cancer, Pancreatic Cancer, Lung Cancer (NSCLC), Advanced Cancer, Advanced Solid Tumors, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the drug is and what side effects occur, helping doctors understand the risks and benefits for patients. The specific primary outcome measures are: Incidence of dose limiting toxicities (Phase 1a) (12 months); Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a) (12 months); Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b) (24 months); Overall response rate (ORR) (Phase 1b) (12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial is important because it explores a new treatment option for patients with advanced cancers that have limited treatment alternatives, potentially filling a gap in care. This research targets Colon Cancer, Pancreatic Cancer, Lung Cancer (NSCLC), Advanced Cancer, Advanced Solid Tumors, where improved treatment options are needed.

Investor Insight

This Phase 1 trial of a novel antibody-drug conjugate (ADC) signals early-stage investment in a competitive oncology market, with potential for significant returns if successful. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if PHN-012 is a suitable option for your specific cancer and if you meet the eligibility criteria. Participation involves regular clinic visits for drug administration, blood tests, scans, and monitoring for side effects. You will need to provide a tumor tissue sample for testing. This trial is currently recruiting participants. The trial is being conducted at 13 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Has histologically confirmed, advanced/metastatic:

  1. Colorectal adenocarcinoma (CRC), or
  2. Non-small cell lung cancer (NSCLC), or
  3. Pancreatic ductal adenocarcinoma (PDAC).
* Has received at least one prior systemic therapy and radiologically or clinically determined progressive disease during or after the most recent line of therapy, and for whom no further standard therapy is available or who is intolerant to standard therapy.
* Has measurable disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Has adequate organ function.
* Has available tumor tissue sample at screening (either an archival specimen or fresh biopsy material).

Exclusion Criteria:

* Had prior treatment with any ADC containing topoisomerase-1 inhibiting payload.
* Has unstable central nervous system metastasis.
* Has persistent toxicities from previous systemic anti-cancer treatments of Grade \>1.
* Has received systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the study drug.
* Has received wide-field radiotherapy (\> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of the study drug, or no recovery from side effects of such intervention.
* Had major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the study drug, or no recovery from side effects of such intervention.
* Has a history of non-infectious pneumonitis (NIP) / interstitial lung disease (ILD) requiring systemic steroids within 6 months prior to first dose of the study drug, active NIP / ILD or suspected NIP / ILD which cannot be ruled out by imaging for Screening.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07127874?

NCT07127874 is a Phase 1 INTERVENTIONAL study titled "A Study of PHN-012 in Patients With Advanced Solid Tumors." It is currently recruiting and is sponsored by Pheon Therapeutics. The trial targets enrollment of 165 participants.

What conditions does NCT07127874 study?

This trial investigates treatments for Colon Cancer, Pancreatic Cancer, Lung Cancer (NSCLC), Advanced Cancer, Advanced Solid Tumors. The primary condition under study is Colon Cancer.

What treatments are being tested in NCT07127874?

The interventions being studied include: PHN-012 (DRUG). PHN-012 is an ADC

What does Phase 1 mean for NCT07127874?

Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.

What is the current status of NCT07127874?

This trial is currently "Recruiting." It started on 2025-09-23. The estimated completion date is 2028-05.

Who is sponsoring NCT07127874?

NCT07127874 is sponsored by Pheon Therapeutics. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07127874?

The trial aims to enroll 165 participants. The trial is currently recruiting and accepting new participants.

How is NCT07127874 designed?

This is a interventional study, uses na allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT07127874?

The primary outcome measures are: Incidence of dose limiting toxicities (Phase 1a) (12 months); Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a) (12 months); Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b) (24 months); Overall response rate (ORR) (Phase 1b) (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07127874 being conducted?

This trial is being conducted at 13 sites, including Los Angeles, California; Washington D.C., District of Columbia; Boston, Massachusetts; St Louis, Missouri and 9 more sites (United States, Spain).

Where can I find official information about NCT07127874?

The official record for NCT07127874 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07127874. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07127874 testing in simple terms?

This trial tests a new drug called PHN-012, which is a type of targeted therapy for cancer. It is for adults with advanced or spreading colon, lung (NSCLC), or pancreatic cancer that has not responded to previous treatments.

Why is this trial significant?

This trial is important because it explores a new treatment option for patients with advanced cancers that have limited treatment alternatives, potentially filling a gap in care.

What are the potential risks of participating in NCT07127874?

Common side effects may include fatigue, nausea, and changes in blood counts. Serious risks can include severe allergic reactions, lung inflammation, or damage to nerves. The drug may cause harm to an unborn baby, so effective birth control is required. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07127874?

Ask your doctor if PHN-012 is a suitable option for your specific cancer and if you meet the eligibility criteria. Participation involves regular clinic visits for drug administration, blood tests, scans, and monitoring for side effects. You will need to provide a tumor tissue sample for testing. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07127874 signal from an investment perspective?

This Phase 1 trial of a novel antibody-drug conjugate (ADC) signals early-stage investment in a competitive oncology market, with potential for significant returns if successful. This is a Phase 1 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will receive the study drug, and their health will be closely monitored. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.