A Study of PHN-010 in 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 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.

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.