Recruiting

Phase 1

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

Sponsor:

Pheon Therapeutics

Code:

NCT07127874

Conditions

Colon Cancer

Pancreatic Cancer

Lung Cancer (NSCLC)

Advanced Cancer

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PHN-012

Study Details

Brief 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.

Conditions

Colon Cancer

Pancreatic Cancer

Lung Cancer (NSCLC)

Advanced Cancer

Advanced Solid Tumors

Study ID

NCT07127874

Start date

Sep 23, 2025

Status verified date

Aug, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

165 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a and Phase 1b

PHN-012 is administered intravenously

Interventions

PHN-012

PHN-012 is an ADC

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Myles Clancy

1-857-342-3090 PHN012001trial@pheontx.com

Locations

PHN-012-001 Site

Recruiting

Los Angeles, California, United States, 90033

PHN-012-001 Site

Recruiting

San Diego, California, United States, 92037

PHN-012-001 Site

Recruiting

Washington D.C., District of Columbia, United States, 20007

PHN-012-001 Site

Recruiting

Boston, Massachusetts, United States, 02114

PHN-012-001 Site

Recruiting

St Louis, Missouri, United States, 63108

PHN-012-001 Site

Recruiting

Durham, North Carolina, United States, 27710

PHN-012-001 Site

Recruiting

Portland, Oregon, United States, 97239

PHN-012-001 Site

Recruiting

Nashville, Tennessee, United States, 37203

PHN-012-001 Site

Recruiting

Houston, Texas, United States, 77030

PHN-012-001 Site

Recruiting

San Antonio, Texas, United States, 78229

PHN-012-001 Site

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Pheon Therapeutics

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

Antibody Drug Conjugate
Carcinoma
Cancer
Solid Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pheon Therapeutics on 2026-08-06.