Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)Phase 1/2NCT06590194
PH009-1 in Patients With EGFR Mutation Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing PH009-1 tablet in people with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC), run by Suzhou Puhe Pharmaceutical Technology Co., LTD at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- PH009-1 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to 31 Aug 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial People's Hospital
Guangzhou, Guangdon, 519041
Wu Yilong, PhD
About this study
Official title: A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of PH009-1 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
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)
Read the detailed description
phase Ia (Dose Escalation Phase) Approximately 17-96 subjects will be enrolled, dose escalation will be implemented by combining accelerated escalation with "3+3" design and safety evaluation requirements as specified. The total number of the subjects will depend upon the number of dose escalation necessary.
Phase Ib (Dose Expansion Phase): 2 to 3 doses selected from escalation doses, up to 20 subjects (subjects in dose escalation are involved) will be enrolled in each expansion arm, the total number of subjects will depend upon the number of dose expansions, expansions may adjusted depends upon the emerging data.
Phase IIa (Cohort Expansion): Approximately 20 subjects will be enrolled in each expansion cohort. Sample size may be adjusted based on emerging data.
- Being tested
- PH009-1 tablet
- Keywords
- NSCLC, EGFR, C797S
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH009-1 tabletDrug
Also called PH009-1
PH009-1 will be administered in fasting state
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: PH009-1 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Up to approximately 2 years
Secondary outcomes (11)
Peak plasma Concentration （Cmax）
To evaluate the pharmacokinetic (PK) characteristics of PH009-1 when given orally following single and multiple doses
Measured: Up to approximately 2 years
Time to reach maximum concentration (Tmax)
To evaluate the pharmacokinetic (PK) characteristics of PH009-1 when given orally following single and multiple doses
Measured: Up to approximately 2 years
Area under the plasma concentration versus time curve (AUC)
To evaluate the pharmacokinetic (PK) characteristics of PH009-1 when given orally following single and multiple doses
Measured: Up to approximately 2 years
Disease Control Rate (DCR)
To obtain a preliminary evaluation of the anti-tumor activity of PH009-1 according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: up to approximately 2 years
Dose escalation and expansion: Objective Response Rate (ORR)
To obtain a preliminary evaluation of the anti-tumor activity of PH009-1 according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: Up to approximately 2 years
Duration of Reaponse (DOR)
To obtain a preliminary evaluation of the anti-tumor activity of PH009-1 according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: up to approximately 2 years
Progression-free survival (PFS)
To obtain a preliminary evaluation of the anti-tumor activity of PH009-1 according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: up to approximately 2 years
Time to progression (TTP)
To obtain a preliminary evaluation of the anti-tumor activity of PH009-1 according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: up to approximately 2 years
overall survival (OS)
To obtain a preliminary evaluation of the anti-tumor activity of PH009-1 according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
Measured: up to approximately 2 years
The concentration of PH009-1 in cerebrospinal fluid (CSF).
To characterise concentration of PH009-1 in CSF
Measured: Up to approximately 2 years
The EGFR gene mutation status in circulating tumor deoxyribonucleic acid (ctDNA)
Confirm EGFR mutation status and evaluate the relationship between different EGFR mutations and drug responses.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Puhe Pharmaceutical Technology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590194
- Sponsor's protocol ID
- PH009-101
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of PH009-1 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT06590194
- Acronym / sponsor ID
- PH009-101
- Keywords
- NSCLC, EGFR, C797S
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Suzhou Puhe Pharmaceutical Technology Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
phase Ia (Dose Escalation Phase) Approximately 17-96 subjects will be enrolled, dose escalation will be implemented by combining accelerated escalation with "3+3" design and safety evaluation requirements as specified. The total number of the subjects will depend upon the number of dose escalation necessary.
Phase Ib (Dose Expansion Phase): 2 to 3 doses selected from escalation doses, up to 20 subjects (subjects in dose escalation are involved) will be enrolled in each expansion arm, the total number of subjects will depend upon the number of dose expansions, expansions may adjusted depends upon the emerging data.
Phase IIa (Cohort Expansion): Approximately 20 subjects will be enrolled in each expansion cohort. Sample size may be adjusted based on emerging data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 75mg, QD | Experimental | Drug: PH009-1 tabletPH009-1 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 |
| 150mg, QD | Experimental | Drug: PH009-1 tabletPH009-1 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 |
| 300mg, QD or 150mg, BID | Experimental | Drug: PH009-1 tabletPH009-1 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 |
| 450mg, QD or 225mg, BID | Experimental | Drug: PH009-1 tabletPH009-1 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 |
| 600mg, QD or 300mg, BID | Experimental | Drug: PH009-1 tabletPH009-1 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 |
| 750mg, QD or 375mg, BID | Experimental | Drug: PH009-1 tabletPH009-1 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PH009-1 tabletAlso: PH009-1PH009-1 will be administered in fasting state | Drug | 150mg, QD, 300mg, QD or 150mg, BID, 450mg, QD or 225mg, BID, 600mg, QD or 300mg, BID, 750mg, QD or 375mg, BID, 75mg, QD |
Primary outcome
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
Time frame: Up to approximately 2 years
To evaluate the safety and tolerability of PH009-1 and to determine the maximal tolerable dose (MTD), or recommended phase II dose (RP2D).
Cohort expansion: Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
To evaluate the preliminary anti-tumor activity at the selected dose(s) of oral PH009-1 according to RECIST v1.1.
Cohort expansion: Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0.
Time frame: Up to approximately 2 years
To evaluate the safety at the selected dose(s) of oral PH009-1.
11 secondary outcomes
Peak plasma Concentration （Cmax）
Time frame: Up to approximately 2 years
Time to reach maximum concentration (Tmax)
Time frame: Up to approximately 2 years
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
Time frame: up to approximately 2 years
Dose escalation and expansion: Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Duration of Reaponse (DOR)
Time frame: up to approximately 2 years
Progression-free survival (PFS)
Time frame: up to approximately 2 years
Time to progression (TTP)
Time frame: up to approximately 2 years
overall survival (OS)
Time frame: up to approximately 2 years
The concentration of PH009-1 in cerebrospinal fluid (CSF).
Time frame: Up to approximately 2 years
The EGFR gene mutation status in circulating tumor deoxyribonucleic acid (ctDNA)
Time frame: Up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PH009-1 tablet in people with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC), run by Suzhou Puhe Pharmaceutical Technology Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fan Jingjing, Physician (13281126921, fanjingjing@puhebiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.