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Colon CancerPhase 1NCT07127874

A Study of PHN-012 in Patients With Advanced Solid Tumors

A Phase 1 study testing PHN-012 in people with Colon Cancer and Pancreatic Cancer, run by Pheon Therapeutics at 26 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
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-012, 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
What is being tested?
PHN-012
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
26 sitesin 3 countries
Study dates
23 Sep 2025to May 2028
Phase
Phase 1

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
  • Non-small cell lung cancer (NSCLC), or
  • 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.
Show all 9Show fewer
  • 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).

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.
  • 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 and contacts

26 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Myles Clancy contact

1-857-342-3090

PHN012001trial@pheontx.com

26 sites in 3 countries

United States11 sites, 11 recruiting

  • PHN-012-001 Site

    Boston, Massachusetts, 02114

    Recruiting

  • PHN-012-001 Site

    Durham, North Carolina, 27710

    Recruiting

  • PHN-012-001 Site

    Fairfax, Virginia, 22031

    Recruiting

  • PHN-012-001 Site

    Houston, Texas, 77030

    Recruiting

  • PHN-012-001 Site

    Los Angeles, California, 90033

    Recruiting

  • PHN-012-001 Site

    Nashville, Tennessee, 37203

    Recruiting

  • PHN-012-001 Site

    Portland, Oregon, 97239

    Recruiting

  • PHN-012-001 Site

    San Antonio, Texas, 78229

    Recruiting

  • PHN-012-001 Site

    San Diego, California, 92037

    Recruiting

  • PHN-012-001 Site

    St Louis, Missouri, 63108

    Recruiting

  • PHN-012-001 Site

    Washington D.C., District of Columbia, 20007

    Recruiting

Other trials in United States

Spain9 sites, 9 recruiting

  • PHN-012-001 Site

    Barcelona, Community of Catalonia, 08023

    Recruiting

  • PHN-012-001 Site

    Barcelona, Community of Catalonia, 08035

    Recruiting

  • PHN-012-001 Site

    Madrid, Madrid, 28007

    Recruiting

  • PHN-012-001 Site

    Madrid, Madrid, 28027

    Recruiting

  • PHN-012-001 Site

    Madrid, Madrid, 28034

    Recruiting

  • PHN-012-001 Site

    Madrid, Madrid, 28040

    Recruiting

  • PHN-012-001 Site

    Madrid, Madrid, 28050

    Recruiting

  • PHN-012-001 Site

    Valencia, Valencia, 46009

    Recruiting

  • PHN-012-001 Site

    Valencia, Valencia, 46010

    Recruiting

Other trials in Spain

South Korea6 sites, 6 recruiting

  • PHN-012-001 Site

    Seongnam-si, Gyeonggi-do, 13496

    Recruiting

  • PHN-012-001 Site

    Seoul, Gangnam-gu, 06351

    Recruiting

  • PHN-012-001 Site

    Seoul, Jongno-gu, 03080

    Recruiting

  • PHN-012-001 Site

    Seoul, Seodaemun-gu, 03722

    Recruiting

  • PHN-012-001 Site

    Seoul, Seoucho-gu, 06591

    Recruiting

  • PHN-012-001 Site

    Seoul, Songpa-gu, 05505

    Recruiting

Other trials in South Korea

About this study

Official title: First-in-Human, Phase 1 Study of PHN-012, 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-012, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.

Being tested
PHN-012
Keywords
Antibody Drug Conjugate, Carcinoma, Cancer, Solid Tumor
Medical subject headings
Colonic Neoplasms, Pancreatic Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Neoplasms

What participants receive

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

  • PHN-012Drug

    PHN-012 is an ADC

Study groups in NCT07127874
Study groupRoleWhat they receive
Phase 1a and Phase 1bExperimentalPHN-012 is administered intravenously
Receives: Drug: PHN-012

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: 12 months

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

    Measured: 12 months

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

    Measured: 24 months

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

    Measured: 12 months

Secondary outcomes (19)

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 24 months

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

    Measured: 12 months

Timeline

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

  1. First posted17 Aug 2025
  2. Study start23 Sep 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionMay 2028 (estimated)

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
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07127874
Sponsor's protocol ID
PHN-012-001
Status last verified
Sep 2026
First submitted
11 Aug 2025
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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