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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457997
• Other study ID #: PHN-010-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 2024
• Est. completion date: July 2027

Study information

• Verified date: June 2024
• Source: Pheon Therapeutics
• Contact: Myles Clancy
• Phone: 617-304-4950
• Email: PHN010001trial[@]pheontx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 273
• Est. completion date: July 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• PHN-010
PHN-010 is an ADC

Locations

Country	Name	City	State
United States	NEXT - Virginia	Fairfax	Virginia
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	NEXT - San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pheon Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting toxicities (Phase 1a)		18 months
Primary	Type, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Phase 1a)		18 months
Primary	Frequency of dose interruptions, reductions, and discontinuations (Phase 1a and 1b)		18 months
Primary	Overall response rate (ORR) (Phase 1b)		36 months
Secondary	Best overall response (BOR) (Phase 1a and 1b)		36 months
Secondary	Disease control rate (DCR) (Phase 1a and 1b)		36 months
Secondary	Progression free survival (PFS) (Phase 1a and 1b)		36 months
Secondary	Time to response (TTR) (Phase 1a and 1b)		36 months
Secondary	Overall survival (OS) (Phase 1a and 1b)		36 months
Secondary	Cancer antigen 125 (CA-125) response (Phase 1a and 1b)		36 months
Secondary	Time to CA-125 response (Phase 1a and 1b)		36 months
Secondary	Pharmacokinetics, maximum concentration (Cmax) of total ADC (Phase 1a and 1b)		36 months
Secondary	Pharmacokinetics, Cmax of total antibody (Phase 1a and 1b)		36 months
Secondary	Pharmacokinetics, Cmax of free payload (Phase 1a and 1b)		36 months
Secondary	Pharmacokinetics, time of Cmax (Tmax) of total ADC (Phase 1a and 1b)		36 months
Secondary	Pharmacokinetics, Tmax of total antibody (Phase 1a and 1b)		36 months
Secondary	Pharmacokinetics, Tmax of free payload (Phase 1a and 1b)		36 months
Secondary	Pharmacokinetics, area under the curve (AUC) of total ADC (Phase 1a and 1b)		36 months
Secondary	Pharmacokinetics, AUC of total antibody (Phase 1a and 1b)		36 months
Secondary	Pharmacokinetics, AUC of total free payload (Phase 1a and 1b)		36 months
Secondary	Pharmacokinetics, terminal half-life (t1/2) of total ADC (Phase 1a and 1b)		36 months
Secondary	Pharmacokinetics, t1/2 of total antibody (Phase 1a and 1b)		36 months
Secondary	Pharmacokinetics, t1/2 of free payload (Phase 1a and 1b)		36 months
Secondary	Concentration of anti-drug antibodies (Phase 1a and 1b)		36 months
Secondary	Type, incidence and severity of AEs and SAEs (Phase 1b)		18 months