Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

NSCLCEGFRC797S

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
+6 more secondary outcomes

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

Interventions

PH009-1 tabletDrug

PH009-1 will be administered in fasting state

Also known as: PH009-1

150mg, QD300mg, QD or 150mg, BID450mg, QD or 225mg, BID600mg, QD or 300mg, BID750mg, QD or 375mg, BID75mg, QD

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Suzhou Puhe Pharmaceutical Technology Co., LTD
Industrylead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdon, 519041, China

Wu Yilong, PhDCONTACT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Fan Jingjing, Physician

CONTACT

13281126921 fanjingjing@puhebiopharma.com

Study Design

Study Type: interventional
Phase: phase 1 2
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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 30, 2026

Estimated (date passed)

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.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (11)

Study Arms (6)

75mg, QD

150mg, QD

300mg, QD or 150mg, BID

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

450mg, QD or 225mg, BID

600mg, QD or 300mg, BID

750mg, QD or 375mg, BID

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (11)

Study Arms (6)

75mg, QD

150mg, QD

300mg, QD or 150mg, BID

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

450mg, QD or 225mg, BID

600mg, QD or 300mg, BID

750mg, QD or 375mg, BID

You may not qualify if:

Data Sharing

Source record

Locations