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Lung CancerPhase 1NCT06457997

A Study of PHN-010 in Patients With Advanced Solid Tumors

A Phase 1 study testing PHN-010 in people with Lung Cancer and Colon Cancer, run by Pheon Therapeutics at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Colon Cancer, Endometrial Cancer
What is being tested?
PHN-010
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
8 sitesUnited States
Study dates
1 Jul 2024to 11 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has histologically confirmed, advanced/metastatic:
  • Colorectal adenocarcinoma (CRC), or
  • Serous, endometroid, or clear-cell epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, or
  • Serous, endometroid or clear-cell endometrial cancer, or
  • Adenocarcinoma or squamous-cell carcinoma of the cervix, or
  • Non-small cell lung cancer (NSCLC).
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  • 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 collected ≤ 3 years prior to the date of informed consent or fresh biopsy material).

Who cannot join

  • 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.
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  • Has acute and/or clinically significant bacterial, fungal, or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
  • Has a history of non-infectious pneumonitis (NIP) / interstitial lung disease (ILD) requiring systemic steroids, active NIP / ILD or suspected NIP / ILD which cannot be ruled out by imaging for Screening.
  • Other protocol defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • NEXT - Virginia

    Fairfax, Virginia, 22031

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • AdventHealth

    Orlando, Florida, 32804

  • NEXT - San Antonio

    San Antonio, Texas, 78229

  • University of Washington/Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: First-in-Human, Phase 1b Study of PHN-010, an Antibody Drug Conjugate, 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 antibody-drug conjugate (ADC), in patients with advanced solid tumors.

Being tested
PHN-010
Keywords
Antibody-Drug Conjugate, Carcinoma, Cancer, Solid Tumor
Medical subject headings
Lung Neoplasms, Colonic Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHN-010Drug

    PHN-010 is an ADC

Study groups in NCT06457997
Study groupRoleWhat they receive
Phase 1a and Phase 1bExperimentalPHN-010 is administered intravenously.
Receives: Drug: PHN-010

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicities (Phase 1a)

    Measured: 18 months

  2. Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a)

    Measured: 18 months

  3. Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)

    Measured: 18 months

  4. Overall response rate (ORR) (Phase 1b)

    Measured: 36 months

Secondary outcomes (21)

  1. Best overall response (BOR) (Phase 1a and 1b)

    Measured: 36 months

  2. Disease control rate (DCR) (Phase 1a and 1b)

    Measured: 36 months

  3. Progression free survival (PFS) (Phase 1a and 1b)

    Measured: 36 months

  4. Time to response (TTR) (Phase 1a and 1b)

    Measured: 36 months

  5. Overall survival (OS) (Phase 1a and 1b)

    Measured: 36 months

  6. Cancer antigen 125 (CA-125) response (Phase 1a and 1b)

    Measured: 36 months

  7. Time to CA-125 response (Phase 1a and 1b)

    Measured: 36 months

  8. Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b)

    Measured: 36 months

  9. Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b)

    Measured: 36 months

  10. Pharmacokinetics, Cmax of free payload (Phase 1a and 1b)

    Measured: 36 months

  11. Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b)

    Measured: 36 months

  12. Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b)

    Measured: 36 months

  13. Pharmacokinetics, Tmax of free payload (Phase 1a and 1b)

    Measured: 36 months

  14. Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b)

    Measured: 36 months

  15. Pharmacokinetics, AUC of total antibody (Phase 1a and 1b)

    Measured: 36 months

  16. Pharmacokinetics, AUC of total free payload (Phase 1a and 1b)

    Measured: 36 months

  17. Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b)

    Measured: 36 months

  18. Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b)

    Measured: 36 months

  19. Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b)

    Measured: 36 months

  20. Concentration of anti-drug antibodies (Phase 1a and 1b)

    Measured: 36 months

  21. Type, incidence and severity of AEs and SAEs (Phase 1b)

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start1 Jul 2024
  3. Primary completion11 Sep 2025
  4. Study completion11 Sep 2025

Why it stopped: The study was terminated by Sponsor for strategic reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06457997
Sponsor's protocol ID
PHN-010-001
Status last verified
Jan 2026
First submitted
6 Jun 2024
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PHN-010 in people with Lung Cancer and Colon Cancer, run by Pheon Therapeutics at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated by Sponsor for strategic reasons.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (Phase 1a) (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06457997.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.

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