- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2025-09
2027-09
2028-05
165
NCT07127874
Pheon Therapeutics
Pheon Therapeutics
INTERVENTIONAL
A Study of PHN-012 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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-08-11 | N/A | 2025-09-02 |
2025-08-11 | N/A | 2025-09-09 |
2025-08-17 | N/A | 2025-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Phase 1a and Phase 1b PHN-012 is administered intravenously | DRUG: PHN-012
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (Phase 1a) | 12 months | |
| Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a) | 12 months | |
| Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b) | 24 months | |
| Overall response rate (ORR) (Phase 1b) | 12 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Best overall response (BOR) (Phase 1a and 1b) | 24 months | |
| Disease control rate (DCR) (Phase 1a and 1b) | 24 months | |
| Progression free survival (PFS) (Phase 1a and 1b) | 24 months | |
| Time to response (TTR) (Phase 1a and 1b) | 24 months | |
| Overall survival (OS) (Phase 1a and 1b) | 24 months | |
| Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b) | 24 months | |
| Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b) | 24 months | |
| Pharmacokinetics, Cmax of free payload (Phase 1a and 1b) | 24 months | |
| Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b) | 24 months | |
| Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b) | 24 months | |
| Pharmacokinetics, Tmax of free payload (Phase 1a and 1b) | 24 months | |
| Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b) | 24 months | |
| Pharmacokinetics, AUC of total antibody (Phase 1a and 1b) | 24 months | |
| Pharmacokinetics, AUC of total free payload (Phase 1a and 1b) | 24 months | |
| Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b) | 24 months | |
| Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b) | 24 months | |
| Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b) | 24 months | |
| Concentration of anti-drug antibodies (Phase 1a and 1b) | 24 months | |
| Type, incidence and severity of AEs and SAEs (Phase 1b) | 12 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Executive Director, Clinical Development Phone Number: 1-857-342-3090 Email: PHN012001trial@pheontx.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
