Trials Sponsors Conditions Drugs Pricing

Conditions

Treatment Treatment Side Effects

Keywords

NSCLC

Outcome Measures

Primary Outcomes (8)

Part 1: Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) .
To investigate the safety and tolerability of YK-029A when given orally to patients with advanced NSCLC with EGFR T790M.
Cycle 1 (Cycle length is equal to [=] 28 days)
Part 1: Number of Participants with Clinically Significant Abnormal Laboratory Values.
To investigate the safety and tolerability of YK-029A when given orally to patients with advanced NSCLC with EGFR T790M.
Cycle 1 (Cycle length is equal to [=] 28 days)
Part 1: Number of Participants with First Cycle Dose-Limiting Toxicities (DLTs).
To establish Maximum Tolerated Dose (MTD) (if possible) and Recommended Phase 2 Dose (PR2D) of YK-029A when given orally in patients with advanced NSCLC with EGFR T790M mutations.
Cycle 1 (Cycle length is equal to [=] 28 days)
Part 1: DLTs of Orally Administered YK-029A.
Toxicity will be Evaluated According to the NCI CTCAE, Version 5.00. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.
Cycle 1 (Cycle length is equal to [=] 28 days)

Secondary Outcomes (12)

Part 1:Cmax: Maximum Plasma Concentration for YK-029A and its Active Metabolites after a Single Oral Dose.
Up to 24 hours; Pre-dose and multiple time points post-dose on Cycle 1 Day 1 (C1D1)
Part1:Tmax: Time to Cmax for YK-029A and its Active Metabolites after a Single Oral Dose.
Up to 24 hours; Pre-dose and multiple time points post-dose on C1D1
Part1:AUC24: Area Under the Plasma Concentration-Time Curve from Time 0 to 24 hours for YK-029A and its Active Metabolites after a Single Oral Dose
Up to 24 hours; Pre-dose and multiple time points post-dose on C1D1
Part1:AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for YK-029A and its Active Metabolites after a Single Oral Dose.
Up to 24 hours; Pre-dose and multiple time points post-dose on C1D1
Part1:Cmax, ss: Maximum Plasma Concentration for YK-029A and its Active Metabolites at Steady State after Multiple Oral Doses.
Up to approximately 168 days; Pre-dose and multiple time points post-dose.

Study Arms (10)

Part 1: Dose Escalation Component

EXPERIMENTAL

In dose-escalation phase, previously treated patients with EGFR T790M mutation were enrolled. YK-029A was given at doses of 50, 100, 150, 200 to 250 mg/day (3+3 design).

Drug: YK-029A

Part 2: Expansion Cohort 1

EXPERIMENTAL

In dose-escalation phase, previously treated patients with EGFR T790M mutation were enrolled. YK-029A was given at doses of 50mg/day and who have no active, measurable central nervous system (CNS) metastases.

Drug: YK-029A

Part 2: Expansion Cohort 2

EXPERIMENTAL

Interventions

YK-029ADrug

Daily dose of YK-029A

Part 1: Dose Escalation ComponentPart 2: Expansion Cohort 1Part 2: Expansion Cohort 2Part 2: Expansion Cohort 3Part 3: ExTension Cohort 4Part 3: ExTension Cohort 5Part 3: ExTension Cohort 6Part 3: ExTension Cohort 7Part 3: ExTension Cohort 8Part 3: ExTension Cohort 9

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

Eligibility Criteria

Age18 Years - 75 Years

Sexall(Gender-based eligibility)

Gender Eligibility Details18-75 Years and older (Adult, Older Adult)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have histologically or cytologically confirmed locally advanced or metastatic NSCLC disease (Stage IIIB or IV) .

Sponsors & Collaborators

Suzhou Puhe Pharmaceutical Technology Co., LTD
Industrylead

Study Sites (35)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230000, China

RECRUITING

Zhihong ZhangCONTACT+861891101855

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

RECRUITING

Yueyin PanCONTACT

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

Duan J, Wu L, Yang K, Zhao J, Zhao Y, Dai X, Li M, Xie Y, Yao Y, Zhao M, Zhou C, Ren X, Liu Z, Pan Y, Li Y, Liu B, Cheng Y, Miao L, Yu Q, Zhang Z, Liu X, Cui J, Zhang Y, Zhang L, Li X, Li X, Shen B, Chen B, Zeng S, Li B, Hu Y, Li L, Wu R, Song Q, Wang J. Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK-029A in Treatment-Naive Patients With Advanced NSCLC Harboring EGFR Exon 20 Insertion Mutations: A Phase 1 Trial. J Thorac Oncol. 2024 Feb;19(2):314-324. doi: 10.1016/j.jtho.2023.09.1449. Epub 2023 Sep 28.
PMID: 37776953DERIVED

Study Officials

Hui Zhao, Doctor
Puhe Biopharma
STUDY DIRECTOR

Central Study Contacts

Hui Zhao, Doctor

CONTACT

+8618911018556 zh@puhebiopharma.com

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 14, 2023

Study Start

March 30, 2018

Actual (reported)

Primary Completion

December 30, 2023

Estimated (date passed)

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

You may not qualify if:

Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days before screening.
Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose or with a wide field of radiation which must be completed within 4 weeks before screening.
NSCLC patients with EGFR T790M mutation previously treated with third-generation EGFR-TKIs (such as AZD9291, CO-1686, HM61713, EGF816, PF-06747775, vometinib, BPI-15086, Ivirtinib maleate, etc.) and their apis or the same drugs in other clinical trials Drug treatment.
Patients with NSCLC with EGFR ex20ins mutation had previously received EGFR ex20ins inhibitors and/or EGFR-cMET double antibodies (including but not limited to TAK-788, bociotinib, JNJ-61186372, DZD9008, vometinib, PLB1004, and AZD9291 in excess of the clinically approved dose (cohort 9 prohibited AZD9291 at any dose) and Drug substance or other similar drug treatment in the clinical trial stage.
NSCLC patients with rare EGFR mutations have previously been treated with third-generation EGFR-Tkis (such as AZD9291, etc.) and their apis or other similar drugs in clinical trials.
Received a moderate or strong CYP4503A inhibitor or moderate or strong CYP3A inducer within 10 days prior to first dose of YK-029A.
Have significant, uncontrolled, or active cardiovascular disease.
Have a known history of uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure.
Have prolonged QTcF interval, or being treated with medications known to be associated with the development of torsades de pointes.
Have an ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics, or a known history of human immunodeficiency virus, hepatitis B virus (HBV), or hepatitis C virus (HCV). Testing is not required in the absence of history.
Currently have or have a history of interstitial lung disease, radiation pneumonitis that required steroid treatment, or drug-related pneumonitis.
Female participants who are lactating and breastfeeding or have a positive urine or serum pregnancy test during the screening period.
Note: Female participants who are lactating will be eligible if they discontinue breastfeeding.
Have gastrointestinal illness or disorder that could affect oral absorption of YK-029A.
Have any condition or illness that, in the opinion of the investigator, might compromise participant safety or interfere with the evaluation of the safety of the drug.
+1 more criteria

Assessing an Oral EGFR Inhibitor,YK-209A in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (12)

Study Arms (10)

Part 1: Dose Escalation Component

Part 2: Expansion Cohort 1

Part 2: Expansion Cohort 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (35)

Related Publications (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Part 2: Expansion Cohort 3

Part 3: ExTension Cohort 4

Part 3: ExTension Cohort 5

Part 3: ExTension Cohort 6

Part 3: ExTension Cohort 7

Part 3: ExTension Cohort 8

Part 3: ExTension Cohort 9

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (12)

Study Arms (10)

Part 1: Dose Escalation Component

Part 2: Expansion Cohort 1

Part 2: Expansion Cohort 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (35)

Related Publications (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Part 2: Expansion Cohort 3

Part 3: ExTension Cohort 4

Part 3: ExTension Cohort 5

Part 3: ExTension Cohort 6

Part 3: ExTension Cohort 7

Part 3: ExTension Cohort 8

Part 3: ExTension Cohort 9

You may not qualify if:

Data Sharing

Source record

Locations