Evaluating PHN-010 for patients with advanced solid tumors

First-in-Human, Phase 1b Study of PHN-010, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors

This study is testing a new drug called PHN-010 to see if it is safe and effective for people with advanced solid tumors like lung or colon cancer.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 273 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pheon Therapeutics (industry)
• Drugs / interventions: radiation
• Locations: 8 sites (Orlando, Florida and 7 other locations)
• Trial ID: NCT06457997 on ClinicalTrials.gov

What this trial studies

This first-in-human study assesses the safety, tolerability, and anti-tumor activity of PHN-010, a novel antibody-drug conjugate, in patients with advanced solid tumors. Participants will have histologically confirmed advanced cancers such as lung, colon, endometrial, ovarian, or cervical cancer. The study will also evaluate the pharmacokinetics and pharmacodynamics of the drug, providing insights into its effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced or metastatic solid tumors who have progressed after at least one prior systemic therapy and have measurable disease.

Not a fit: Patients with early-stage cancers or those who have not received prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies involving antibody-drug conjugates have shown promising results, indicating potential success for this novel approach.

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.

Where this trial is running

Orlando, Florida and 7 other locations

• AdventHealth — Orlando, Florida, United States (RECRUITING)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (RECRUITING)
• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• NEXT - San Antonio — San Antonio, Texas, United States (RECRUITING)
• NEXT - Virginia — Fairfax, Virginia, United States (RECRUITING)
• University of Washington/Fred Hutchinson Cancer Center — Seattle, Washington, United States (RECRUITING)

Study contacts

• Study coordinator: Myles Clancy

Conditions: Lung Cancer, Colon Cancer, Endometrial Cancer, Ovarian Cancer, Cervical Cancer, Advanced Solid Tumor, Advanced Cancer, Antibody-Drug Conjugate