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.
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
- Conditions the study is for
- Colon Cancer, Pancreatic Cancer, Lung Cancer (NSCLC)
- 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
- Are there results?
- Not yet: the study is under way
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.
26 sites in 3 countries
United States11 sites, 11 recruiting
- 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
Spain9 sites, 9 recruiting
- 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
South Korea6 sites, 6 recruiting
- 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
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.
- Conditions
- Colon Cancer, Pancreatic Cancer, Lung Cancer (NSCLC), Advanced Cancer, 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 group | Role | What they receive |
|---|---|---|
| Phase 1a and Phase 1b | Experimental | PHN-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.
Incidence of dose limiting toxicities (Phase 1a)
Measured: 12 months
Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a)
Measured: 12 months
Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)
Measured: 24 months
Overall response rate (ORR) (Phase 1b)
Measured: 12 months
Secondary outcomes (19)
Best overall response (BOR) (Phase 1a and 1b)
Measured: 24 months
Disease control rate (DCR) (Phase 1a and 1b)
Measured: 24 months
Progression free survival (PFS) (Phase 1a and 1b)
Measured: 24 months
Time to response (TTR) (Phase 1a and 1b)
Measured: 24 months
Overall survival (OS) (Phase 1a and 1b)
Measured: 24 months
Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b)
Measured: 24 months
Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b)
Measured: 24 months
Pharmacokinetics, Cmax of free payload (Phase 1a and 1b)
Measured: 24 months
Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b)
Measured: 24 months
Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b)
Measured: 24 months
Pharmacokinetics, Tmax of free payload (Phase 1a and 1b)
Measured: 24 months
Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b)
Measured: 24 months
Pharmacokinetics, AUC of total antibody (Phase 1a and 1b)
Measured: 24 months
Pharmacokinetics, AUC of total free payload (Phase 1a and 1b)
Measured: 24 months
Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b)
Measured: 24 months
Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b)
Measured: 24 months
Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b)
Measured: 24 months
Concentration of anti-drug antibodies (Phase 1a and 1b)
Measured: 24 months
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.
- First posted17 Aug 2025
- Study start23 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Pheon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human, Phase 1 Study of PHN-012, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07127874
- Acronym / sponsor ID
- PHN-012-001
- Conditions
- Colon Cancer, Pancreatic Cancer, Lung Cancer (NSCLC), Advanced Cancer, Advanced Solid Tumors
- Keywords
- Antibody Drug Conjugate, Carcinoma, Cancer, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Pheon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1a and Phase 1b | Experimental | Drug: PHN-012PHN-012 is administered intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has histologically confirmed, advanced/metastatic:
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHN-012PHN-012 is an ADC | Drug | Phase 1a and Phase 1b |
Primary outcome
Incidence of dose limiting toxicities (Phase 1a)
Time frame: 12 months
Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a)
Time frame: 12 months
Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)
Time frame: 24 months
Overall response rate (ORR) (Phase 1b)
Time frame: 12 months
19 secondary outcomes
Best overall response (BOR) (Phase 1a and 1b)
Time frame: 24 months
Disease control rate (DCR) (Phase 1a and 1b)
Time frame: 24 months
Progression free survival (PFS) (Phase 1a and 1b)
Time frame: 24 months
Time to response (TTR) (Phase 1a and 1b)
Time frame: 24 months
Overall survival (OS) (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, Cmax of free payload (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, Tmax of free payload (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, AUC of total antibody (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, AUC of total free payload (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b)
Time frame: 24 months
Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b)
Time frame: 24 months
Concentration of anti-drug antibodies (Phase 1a and 1b)
Time frame: 24 months
Type, incidence and severity of AEs and SAEs (Phase 1b)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Spain, South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Myles Clancy (1-857-342-3090, PHN012001trial@pheontx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (Phase 1a) (time frame: 12 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?
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 Sep 2026.