TerminatedNCT06457997Updated Jan 29, 2026

A Study of PHN-010 in Patients With Advanced Solid Tumors

A Phase 1 interventional study of PHN-010 in Lung Cancer, Colon Cancer and Endometrial Cancer, sponsored by Pheon Therapeutics. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.

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

Why this study was terminated

The study was terminated by Sponsor for strategic reasons.

Phase: Phase 1
Study type: Interventional
Enrollment: 26
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.

Conditions studied

Lung Cancer
Colon Cancer
Endometrial Cancer
Ovarian Cancer
Cervical Cancer
Advanced Solid Tumor
Advanced Cancer

Browse trials for

Keywords

Antibody-Drug Conjugate
Carcinoma
Cancer
Solid Tumor

Who can participate

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

Eligibility criteria

Key Inclusion Criteria:

Has histologically confirmed, advanced/metastatic:
1. Colorectal adenocarcinoma (CRC), or
2. Serous, endometroid, or clear-cell epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, or
3. Serous, endometroid or clear-cell endometrial cancer, or
4. Adenocarcinoma or squamous-cell carcinoma of the cervix, or
5. Non-small cell lung cancer (NSCLC).
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 collected ≤ 3 years prior to the date of informed consent 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 acute and/or clinically significant bacterial, fungal, or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
Has a history of non-infectious pneumonitis (NIP) / interstitial lung disease (ILD) requiring systemic steroids, active NIP / ILD or suspected NIP / ILD which cannot be ruled out by imaging for Screening.

Other protocol defined Inclusion/Exclusion criteria apply.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 26 participants (actual)

Study arms

Experimental
Phase 1a and Phase 1b
PHN-010 is administered intravenously.
Drug: PHN-010

Interventions

DrugPHN-010
PHN-010 is an ADC

What researchers measure

Primary outcomes

Incidence of dose limiting toxicities (Phase 1a)
Time frame: 18 months
Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a)
Time frame: 18 months
Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)
Time frame: 18 months
Overall response rate (ORR) (Phase 1b)
Time frame: 36 months

Secondary outcomes

Best overall response (BOR) (Phase 1a and 1b)
Time frame: 36 months
Disease control rate (DCR) (Phase 1a and 1b)
Time frame: 36 months
Progression free survival (PFS) (Phase 1a and 1b)
Time frame: 36 months
Time to response (TTR) (Phase 1a and 1b)
Time frame: 36 months
Overall survival (OS) (Phase 1a and 1b)
Time frame: 36 months
Cancer antigen 125 (CA-125) response (Phase 1a and 1b)
Time frame: 36 months
Time to CA-125 response (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, Cmax of free payload (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, Tmax of free payload (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, AUC of total antibody (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, AUC of total free payload (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b)
Time frame: 36 months
Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b)
Time frame: 36 months
Concentration of anti-drug antibodies (Phase 1a and 1b)
Time frame: 36 months
Type, incidence and severity of AEs and SAEs (Phase 1b)
Time frame: 18 months

Study locations

8 sites

AdventHealth
Orlando, Florida 32804, United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215, United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065, United States
Sarah Cannon Research Institute
Nashville, Tennessee 37203, United States
MD Anderson Cancer Center
Houston, Texas 77030, United States
NEXT - San Antonio
San Antonio, Texas 78229, United States
NEXT - Virginia
Fairfax, Virginia 22031, United States
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington 98109, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT06457997
Lead sponsor: Pheon Therapeutics
Responsible party: Sponsor
First posted: Jun 13, 2024
Start date: Jul 1, 2024
Primary completion: Sep 11, 2025
Completion: Sep 11, 2025
Last update: Jan 29, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lung Neoplasms→

Other studies from this sponsor

Pheon Therapeutics

A Study of PHN-012 in Patients With Advanced Solid TumorsRecruitingNCT07127874Phase 1

Start the discussion