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RecruitingNCT07127874Updated Sep 29, 2026

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

A Phase 1 interventional study of PHN-012 in Colon Cancer, Pancreatic Cancer and Lung Cancer (NSCLC), sponsored by Pheon Therapeutics. Recruiting at 26 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Pheon Therapeutics · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
165
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colon Cancer
  • Pancreatic Cancer
  • Lung Cancer (NSCLC)
  • Advanced Cancer
  • Advanced Solid Tumors

Keywords

  • Antibody Drug Conjugate
  • Carcinoma
  • Cancer
  • Solid Tumor
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
165 participants (estimated)

Study arms

  • Experimental
    Phase 1a and Phase 1b

    PHN-012 is administered intravenously

    Drug: PHN-012

Interventions

  • DrugPHN-012

    PHN-012 is an ADC

05

What researchers measure

Primary outcomes

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 24 months

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

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 24 months

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

    Time frame: 12 months

06

Study locations

26 of 26 sites recruiting
  • PHN-012-001 Site
    Los Angeles, California 90033, United States
    Recruiting
  • PHN-012-001 Site
    San Diego, California 92037, United States
    Recruiting
  • PHN-012-001 Site
    Washington D.C., District of Columbia 20007, United States
    Recruiting
  • PHN-012-001 Site
    Boston, Massachusetts 02114, United States
    Recruiting
  • PHN-012-001 Site
    St Louis, Missouri 63108, United States
    Recruiting
  • PHN-012-001 Site
    Durham, North Carolina 27710, United States
    Recruiting
  • PHN-012-001 Site
    Portland, Oregon 97239, United States
    Recruiting
  • PHN-012-001 Site
    Nashville, Tennessee 37203, United States
    Recruiting
  • PHN-012-001 Site
    Houston, Texas 77030, United States
    Recruiting
  • PHN-012-001 Site
    San Antonio, Texas 78229, United States
    Recruiting
  • PHN-012-001 Site
    Fairfax, Virginia 22031, United States
    Recruiting
  • PHN-012-001 Site
    Seoul, Gangnam-gu 06351, South Korea
    Recruiting
  • PHN-012-001 Site
    Seongnam-si, Gyeonggi-do 13496, South Korea
    Recruiting
  • PHN-012-001 Site
    Seoul, Jongno-gu 03080, South Korea
    Recruiting
  • PHN-012-001 Site
    Seoul, Seodaemun-gu 03722, South Korea
    Recruiting
  • PHN-012-001 Site
    Seoul, Seoucho-gu 06591, South Korea
    Recruiting
  • PHN-012-001 Site
    Seoul, Songpa-gu 05505, South Korea
    Recruiting
  • PHN-012-001 Site
    Barcelona, Community of Catalonia 08023, Spain
    Recruiting
  • PHN-012-001 Site
    Barcelona, Community of Catalonia 08035, Spain
    Recruiting
  • PHN-012-001 Site
    Madrid, Madrid 28007, Spain
    Recruiting
  • PHN-012-001 Site
    Madrid, Madrid 28027, Spain
    Recruiting
  • PHN-012-001 Site
    Madrid, Madrid 28034, Spain
    Recruiting
  • PHN-012-001 Site
    Madrid, Madrid 28040, Spain
    Recruiting
  • PHN-012-001 Site
    Madrid, Madrid 28050, Spain
    Recruiting
  • PHN-012-001 Site
    Valencia, Valencia 46009, Spain
    Recruiting
  • PHN-012-001 Site
    Valencia, Valencia 46010, Spain
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07127874
Lead sponsor
Pheon Therapeutics
Responsible party
Sponsor
First posted
Aug 17, 2025
Start date
Sep 23, 2025
Primary completion
Sep 2027 (estimated)
Completion
May 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Myles Clancy
Contact
PHN012001trial@pheontx.com
1-857-342-3090

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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