PH009-1 in Patients With EGFR Mutation Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

NCT06590194 | Not Yet Recruiting Phase 1

• 1 other identifier: PH009-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The study will contain three stages: Phase I includes dose escalation phase (i.e., phase Ia) and dose expansion phase (i.e., phase Ib). Once the dosage regimen is confirmed, the sponsor can decide to start the cohort expansion phase (i.e., phase IIa)

Conditions

Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Keywords

NSCLC; EGFR; C797S

Outcome Measures

Primary Outcomes (3)

• Dose escalation and dose expansion: Incidence of dose-limiting toxicities (DLTs), Incidence and severity of treatment-emergent adverse events (TEAEs) with severity determined according to National Cancer Institute (NCI) CTCAE v5.0

  To evaluate the safety and tolerability of PH009-1 and to determine the maximal tolerable dose (MTD), or recommended phase II dose (RP2D).

  Up to approximately 2 years

• Cohort expansion: Objective Response Rate (ORR)

  To evaluate the preliminary anti-tumor activity at the selected dose(s) of oral PH009-1 according to RECIST v1.1.

  Up to approximately 2 years

• Cohort expansion: Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0.

  To evaluate the safety at the selected dose(s) of oral PH009-1.

  Up to approximately 2 years

Secondary Outcomes (11)

• Peak plasma Concentration （Cmax）

  Up to approximately 2 years

• Time to reach maximum concentration (Tmax)

  Up to approximately 2 years

• Area under the plasma concentration versus time curve (AUC)

  Up to approximately 2 years

• Disease Control Rate (DCR)

  up to approximately 2 years

• Dose escalation and expansion: Objective Response Rate (ORR)

  Up to approximately 2 years

Study Arms (6)

75mg, QD

EXPERIMENTAL

PH009-1 75mg QD orally administered, receive a single dose orally, followed by a 4-day washout period. Then, the same dose of PH009-1 will be administered QD, every 21 days a cycle until disease progression or not tolerated

Drug: PH009-1 tablet

150mg, QD

EXPERIMENTAL

PH009-1 150mg QD orally administered, receive a single dose orally, followed by a 4-day washout period. Then, the same dose of PH009-1 will be administered QD, every 21 days a cycle until disease progression or not tolerated

Drug: PH009-1 tablet

300mg, QD or 150mg, BID

EXPERIMENTAL

PH009-1 300mg QD or 150mg BID orally administered, receive a single dose orally, followed by a 4-day washout period. Then, the same dose of PH009-1 will be administered QD, every 21 days a cycle until disease progression or not tolerated

Drug: PH009-1 tablet

450mg, QD or 225mg, BID

EXPERIMENTAL

PH009-1 450mg QD or 225mg BID orally administered, receive a single dose orally, followed by a 4-day washout period. Then, the same dose of PH009-1 will be administered QD, every 21 days a cycle until disease progression or not tolerated

Drug: PH009-1 tablet

600mg, QD or 300mg, BID

EXPERIMENTAL

PH009-1 600mg QD or 300mg BID orally administered, receive a single dose orally, followed by a 4-day washout period. Then, the same dose of PH009-1 will be administered QD, every 21 days a cycle until disease progression or not tolerated

Drug: PH009-1 tablet

750mg, QD or 375mg, BID

EXPERIMENTAL

PH009-1 750mg QD or 375mg BID orally administered, receive a single dose orally, followed by a 4-day washout period. Then, the same dose of PH009-1 will be administered QD, every 21days a cycle until disease progression or not tolerated

Drug: PH009-1 tablet

Interventions

PH009-1 tablet DRUG

PH009-1 will be administered in fasting state

Also known as: PH009-1

150mg, QD; 300mg, QD or 150mg, BID; 450mg, QD or 225mg, BID; 600mg, QD or 300mg, BID; 750mg, QD or 375mg, BID; 75mg, QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, signed informed consent form before any trial-related processes.
• Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC.
• Subjects must have NSCLC harboring one or more active EGFR mutations.
• patients must have at least one measurable tumor lesion per RECIST v1.1 criteria as per Investigator\'s assessment.
• The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.
• Life expectancy ≥12 weeks.
• Adequate hematologic and organ function per protocol.
• WOCBP must have a negative serum and/or urine pregnancy test result within 7 days prior to the first dose of PH009-1.

You may not qualify if:

• Treatment with any of the following:
• Prior treatment with an EGFR-TKI within 8 days prior to the first dose of PH009-1; Prior treatment with immunotherapy or biotherapy within 4 weeks prior to the first dose of PH009-1; Radiotherapy (palliative radiotherapy completed at least 2 weeks prior to the first dose of Ph009-1 can be enrolled) within 4 weeks prior to the first dose of PH009-1; Herbal therapy that has anti-tumor effects within 2 weeks prior to the first dose of PH009-1; Mitomycin and nitrosourea within 6 weeks prior to the first dose of PH009-1; Oral fluorouracil such as tegafur and capecitabine within 2 weeks prior to the first dose of PH009-1; Chemotherapy (except for mitomycin, nitrosourea, and fluorouracil oral drugs), or other anti-tumor drugs for the treatment of NSCLC within 4 weeks prior to the first dose of PH009-1. Marketed and/or experimental drug treatment for EGFR C797S mutations.
• Is currently participating and receiving investigational therapy or using an investigational device, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the investigational product, whichever is longer, prior to the first dose of PH009-1.
• Is expected to require any other form of anti-tumor therapy while on study.
• Unresolved toxicity greater than CTCAE v5.0 Grade 1 from prior anti-tumor therapy prior to the first dose.
• Medical history of severe eye disease or skin disease without recovery to CTCAE v5.0 Grade 0 or 1 prior to the first dose.
• Any of the following cardiovascular diseases within the last 6 months: include but not limited to QTc interval ≥ 470 msec.
• Medical history of ILD.
• Subjects with gastrointestinal disorders that may affect oral administration or interfere with the absorption of PH009-1, or severe gastrointestinal disease within 4 weeks prior to the first dose of PH009-1 and did not recover to ≤ CTCAE v5.0 Grade 2.
• Major surgery or significant traumatic injury occurring within 4 weeks prior to the first dose of PH009-1 or anticipation of need for a major surgery during the study.
• Has any bleeding tendency or coagulopathy within 6 months prior to the first dose of PH009-1.

Sponsors & Collaborators

• Suzhou Puhe Pharmaceutical Technology Co., LTD: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdon, 519041, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Fan Jingjing, Physician

CONTACT

13281126921; fanjingjing@puhebiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)