Non Small Cell Lung CancerPhase 1NCT05430386
Study of HS-10241 in Combination With Almonertinib in Patients With Locally Advanced or Metastatic NSCLC
A Phase 1 study testing HS-10241 in people with Non Small Cell Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is conducted to determine the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-10241 when given together with Almonertinib in patients with EGFRm+ advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- HS-10241
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2022to 31 Dec 2023
- Phase
- Phase 1
- 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
- Men or women aged more than or equal to (≥) 18 years.
- Patients histologically or cytologically confirmed with locally advanced or metastatic NSCLC.
- According to Recist1.1, at least 1 target lesion that should be measurable lesions without local treatment like irradiation or with definite progression after local treatment and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15mm)
- ECOG performance status of 0-1with no deterioration within 2 weeks before enrollment.
- Estimated life expectancy ≥three months.
- Females of child bearing age should adapt adequate contraceptive measures and should not be breastfeeding from the signing of informed consent to 6 months after the last treatment of the study. Male patients should be willing to use barrier contraception (i.e., condoms) from the signing of informed consent to 6 months after the last treatment of the study.
Show all 16Show fewer
- Females must have a negative pregnancy test in 7 days prior to start of first dose if of childbearing potential or must have evidence of non-childbearing potential by fulfilling any one of the following criteria:
- Postmenopausal defined as age more than 60 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments.
- Women under 60 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more, following cessation of exogenous hormonal treatments, and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the postmenopausal range for the laboratory.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not by tubal ligation.
- Signed and dated Informed Consent Form. Specific inclusion criteria Part 1 Patients have previously received any EGFR TKI continuous treatment (such as Gefitinib, Erlotinib, Osimertinib or Almonertinib) and had disease progression by imaging recorded. Before the first dose, all patients must provide imaging evidence of disease progression during or after the last treatment period. Before the start of study treatment, patients need to provide all the following test results detected by tumor biopsy tissue or blood samples with disease progression during or after the last treatment: EGFR sensitive mutation (either exon 19 deletion or L858R mutation); T790M status (negative or positive). The above test results of local laboratories can be accepted without confirmation of the central laboratory. If there are no local laboratory test results, then tumor tissue or blood samples meeting the protocol requirements should be sent to the central laboratory for testing and the results should be obtained before the first dose of study drug.
- Part2 Cohort 1 -Patients have previously received the 1st/2nd/3rd-generation EGFR TKI (only one kind of them) and had disease progression by imaging recorded with centrally confirmed EGFR mutation, T790M negative and MET-positive.
- Cohort2- Patients have not received any systemic treatment of advanced NSCLC with centrally confirmed EGFR mutation and MET-positive.
- Cohort3- Patients have previously received both 1st/2nd and 3rd-generation EGFR-TKI and had disease progression by imaging recorded with centrally confirmed EGFR mutation and MET-positive.
- Cohort4-Patients have previously received the 1st/2nd-generation EGFR TKI continuous treatment (not received the 3rd-generation EGFR TKI treatment) and had disease progression by imaging recorded with centrally confirmed EGFR mutation, T790M positive and MET-positive.
- Definition of MET-positive (any one of the following): ① Fluorescence in situ hybridization (FISH): MET gene copy number ≥ 5 or MET/CEP7 ratio ≥ 2; ② Immunohistochemistry (IHC): ≥ 50% tumor cells MET 3+.
Who cannot join
- Treatment with any of the following:
- Previous or current treatment with drugs targeting the c-MET/HGF pathway.
- Any cytotoxic chemotherapy, investigational agents, antitumor traditional Chinese Medicine and any other anticancer drugs for the treatment of advanced NSCLC within 14 days before the first dose of study drug; or requiring treatment with these drugs during the study.
- Any antitumor monoclonal antibody therapy within 28 days before the first dose of study drug.
- Local radiotherapy within 2 weeks of the first dose of study drug; receiving radiation to > 30% of the bone marrow or with a wide field of radiation within 4 weeks before the first dose of study drug.
- Pleural or peritoneal effusion requiring clinical intervention (except for effusion not requiring drainage or being stable after drainage for at least 14 days before the first dose of study drug). Pericardial effusion (except for effusion being stable after drainage for at least 14 days before the first dose of study drug).
Show all 48Show fewer
- Major surgery within 4 weeks of the first dose of study drug.
- Spinal cord compression or brain metastases (except for that being asymptomatic and stable for at least 4 weeks, not requiring steroids for at least 2 weeks prior to start of study treatment and with no obvious edema around the tumor focus by imaging examination).
- Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.
- Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study.
- Currently receiving or requiring long-term treatment with warfarin (LMWH is allowed).
- Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity.
- History of other primary malignancies, excluding:
- Malignancies that have been recovered and inactive for ≥5 years prior to inclusion with a very low risk of recurrence.
- Non-melanoma skin cancer or malignant freckle mole with adequate treatment and no evidence of disease recurrence.
- Carcinoma in situ with adequate treatment and no evidence of disease recurrence.
- Non metastatic prostate cancer with definite treatment.
- Inadequate bone marrow reserve or organ function, as demonstrated by any of the following laboratory values:
- Absolute neutrophil count (ANC) <1.5×109 / L
- Platelet count <90×109 / L
- Hemoglobin <90 g/L
- Total bilirubin (TBL) > 1.5 × ULN or > 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases.
- One or both of Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN) or > 5 × ULN in the presence of liver metastases.
- Creatinine > 1.5 × ULN concurrent with creatinine clearance < 50 mL/min; confirmation of creatinine clearance is only required when creatinine is > 1.5 × ULN.
- International normalized ratio (INR) > 1.5, and partially activated prothrombin time (APTT) > 1.5 × ULN.
- Serum albumin (ALB) < 28 g/L
- Serum lipase or serum amylase > 1.5 × ULN.
- Any of the following cardiac criteria:
- Resting corrected QT interval (QTc) > 470 ms obtained from electrocardiogram (ECG), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF). See Appendix G for fridericia formula.
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval > 250 ms).
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, intractable hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.
- Left ventricular ejection fraction (LVEF) ≤ 50%.
- Severe, uncontrolled or active cardiovascular diseases.
- Diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug, or the glycosylated hemoglobin value ≥ 7.5% in the screening period.
- Severe or poorly controlled hypertension.
- Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 months prior to the first dose of study drug.
- Serious arteriovenous thrombosis events occurred within 3 months before the first dose.
- Severe infections occurred within 4 weeks before the first dose.
- Patients who have received continuous steroid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment (except for asthma patients who need long-term inhaled glucocorticoids and patients with topical corticosteroids), or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation
- Clinically severe gastrointestinal dysfunction that may affect drug intake, transport or absorption.
- The presence of active infectious diseases has been known before the first dose such as hepatitis B (the test result of virus surface antigen [HBsAg] in the screening stage is positive, and the test value of HBV-DNA is ≥ 2 × 103iu / ml; if the retested result after regular antiviral treatment has been reduced to 2 × 103 IU / ml or less, patients can be enrolled), hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.
- Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
- Other moderate or severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.
- Previous history of serious neurological or mental disorders, including epilepsy, dementia or severe depression and any other status that may interfere in assessment.
- Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
- History of hypersensitivity to any active or inactive ingredient of HS-10241/Almonertinib or to drugs with a similar chemical structure or class to HS-10241/Almonertinib.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200032
Zhonglin Chen, MD, 021-22200000, chestgcp@126.com
Shun Lu, MD
About this study
Official title: A Phase Ib Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10241 in Combination With Almonertinib in Patients With Locally Advanced or Metastatic NSCLC.
This study is conducted to determine the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-10241 when given together with Almonertinib in patients with EGFRm+ advanced NSCLC.
Read the detailed description
This is a phase Ⅰb, multicenter study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HS-10241 administered orally in combination with Almonertinib in patients with EGFRm+ locally advanced or metastatic NSCLC who have progressed following prior EGFR-TKI therapy.
The study consist of two parts: Part 1 is the dose escalation period to observe the safety, tolerance, PK characteristics and preliminary anti-tumor activity, and determine the maximum tolerated dose (MTD) or maximum applicable dose (MAD) of combined administration; Part 2 is the dose expansion period to select appropriate doses in different target populations and further evaluate the efficacy, safety, tolerance and PK characteristics of combined administration, and determine the phase II recommended dose (RP2D).
All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug. Patients of this study will be permitted to continue therapy with assessments for progression once every 8 weeks, if the product is well tolerated and the subject has stable disease or better. Survival follow-up is recommended once every 12 weeks.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- HS-10241
- Keywords
- NSCLC, c-Met,
- 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.
HS-10241Drug
Also called Almonertinib
Dose escalation: HS-10241 and Almonertinib will be administered in combination. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Dose expansion: HS-10241 and Almonertinib will be administered in the dose identified in Part 1 to further investigate the safety, tolerability, pharmacokinetics, and efficacy of this combination therapy.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation and dose expansion | Experimental | HS-10241 in combination with Almonertinib Receives: Drug: HS-10241 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part1-To determine the maximum tolerated dose (MTD)
MTD was defined as the previous dose level at which 2 out of 3 patients or 2 out of 6 patients experienced a DLT.
Measured: Up to day 28 from the first dose (4 weeks).
Part2- Objective response rate (ORR )
ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1.
Measured: From first dose until disease progression or withdrawal from study, assessed up to 24 months.
Secondary outcomes (14)
Incidence and severity of treatment-emergent adverse events
Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, and NCI CTCAE v5.0.
Measured: From first dose until 28 days after the last dose
Observed maximum plasma concentration (Cmax) after the first dose
Cmax will be obtained following administration of the first dose of HS-10241 or Almonertinib on Cycle 1.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 first dose
Observed maximum plasma concentration (C ss,max) after multiple dose
C ss,max of HS-10241 or Almonertinib will be obtained on Day 1 of dosing in the second 28-Day cycle of therapy.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of dosing in the second 28-Day cycle of therapy
Observed minimum plasma concentration (C ss,min) after multiple dose
C ss,min of HS-10241 or Almonertinib will be obtained on Day 1 of dosing in the second 28-Day cycle of therapy.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of dosing in the second 28-Day cycle of therapy
Time to reach maximum plasma concentration (Tmax) after the first dose
Tmax of HS-10241 or Almonertinib will be obtained following administration of the first oral dose
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 first dose
Time to reach maximum plasma concentration (T ss,max) after multiple dose
T ss,max of HS-10241 or Almonertinib will be obtained on Day 1 of dosing in the second 28-Day cycle of therapy.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of dosing in the second 28-Day cycle of therapy
Apparent terminal half-life (t1/2) after the first dose
Apparent terminal half-life of HS-10241 or Almonertinib is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 first dose
Area under plasma concentration versus time curve from zero to the 12 hour sampling time (AUC0-12) after single dose
Area under the plasma concentration versus time curve from time zero to the 12 hour sampling time 12 at which the concentration of HS-10241 was at or above the lower limit of quantification (LLQ). AUC0-12 was to be calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose on Day 1 first dose
Area under plasma concentration versus time curve from zero to the 24 hour sampling time (AUC0-24) after single dose
Area under the plasma concentration versus time curve from time zero to the 24 hour sampling time 24 at which the concentration of Almonertinib was at or above the lower limit of quantification (LLQ). AUC0-24 was to be calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 single dose
Objective response rate (ORR)- Part1
ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1.
Measured: From first dose until disease progression or withdrawal from study, assessed up to 24 months.
Disease control rate (DCR)
Objective response was assessed by RECIST 1.1 thereby to evaluate disease control rate. Disease control was defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 5 weeks).
Measured: From first dose until disease progression or withdrawal from study, assessed up to 24 months.
Duration of response (DoR)
Duration of response assessed by RECIST 1.1. Duration of response was defined as the time from when the criteria for CR or PR were first met to the occurrence of an objective disease progression (PD) or death.
Measured: From first dose until disease progression or withdrawal from study, assessed up to 24 months.
Progression-free survival (PFS)
Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival. Progression-free survival was defined as the time from date of first dose until the documentation of objective disease progression (PD) or death from any cause in the absence of progression (whichever occurred first), regardless of whether they subsequently received non-study anti-cancer therapy.
Measured: From first dose until disease progression or withdrawal from study, assessed up to 24 months.
Overall survival (OS)-Part 2
OS was defined as time from randomization until the date of death due to any cause.
Measured: From first dose until disease progression or withdrawal from study, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start5 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, MD, Principal investigator, Shanghai Chest HospitalJiahua Chen, MD, Principal investigator, Hunan Cancer HospitalXiaorong Dong, MD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyYing Cheng, MD, Principal investigator, Jilin Provincial Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430386
- Sponsor's protocol ID
- HS-10241-102
- Status last verified
- Feb 2023
- First submitted
- 14 Jun 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10241 in Combination With Almonertinib in Patients With Locally Advanced or Metastatic NSCLC.
- ClinicalTrials.gov ID
- NCT05430386
- Acronym / sponsor ID
- HS-10241-102
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, c-Met,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Jun 2022 (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.
This study is conducted to determine the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-10241 when given together with Almonertinib in patients with EGFRm+ advanced NSCLC.
Detailed description
This is a phase Ⅰb, multicenter study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HS-10241 administered orally in combination with Almonertinib in patients with EGFRm+ locally advanced or metastatic NSCLC who have progressed following prior EGFR-TKI therapy.
The study consist of two parts: Part 1 is the dose escalation period to observe the safety, tolerance, PK characteristics and preliminary anti-tumor activity, and determine the maximum tolerated dose (MTD) or maximum applicable dose (MAD) of combined administration; Part 2 is the dose expansion period to select appropriate doses in different target populations and further evaluate the efficacy, safety, tolerance and PK characteristics of combined administration, and determine the phase II recommended dose (RP2D).
All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug. Patients of this study will be permitted to continue therapy with assessments for progression once every 8 weeks, if the product is well tolerated and the subject has stable disease or better. Survival follow-up is recommended once every 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and dose expansion | Experimental | Drug: HS-10241HS-10241 in combination with Almonertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men or women aged more than or equal to (≥) 18 years.
- Patients histologically or cytologically confirmed with locally advanced or metastatic NSCLC.
- According to Recist1.1, at least 1 target lesion that should be measurable lesions without local treatment like irradiation or with definite progression after local treatment and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15mm)
- ECOG performance status of 0-1with no deterioration within 2 weeks before enrollment.
- Estimated life expectancy ≥three months.
Key exclusion criteria (48 listed)
- Treatment with any of the following:
- Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity.
- History of other primary malignancies, excluding:
- Inadequate bone marrow reserve or organ function, as demonstrated by any of the following laboratory values:
- Any of the following cardiac criteria:
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 |
|---|---|---|
| HS-10241Also: AlmonertinibDose escalation: HS-10241 and Almonertinib will be administered in combination. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. Dose expansion: HS-10241 and Almonertinib will be administered in the dose identified in Part 1 to further investigate the safety, tolerability, pharmacokinetics, and efficacy of this combination therapy. | Drug | Dose escalation and dose expansion |
Primary outcome
Part1-To determine the maximum tolerated dose (MTD)
Time frame: Up to day 28 from the first dose (4 weeks).
MTD was defined as the previous dose level at which 2 out of 3 patients or 2 out of 6 patients experienced a DLT.
Part2- Objective response rate (ORR )
Time frame: From first dose until disease progression or withdrawal from study, assessed up to 24 months.
ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1.
14 secondary outcomes
Incidence and severity of treatment-emergent adverse events
Time frame: From first dose until 28 days after the last dose
Observed maximum plasma concentration (Cmax) after the first dose
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 first dose
Observed maximum plasma concentration (C ss,max) after multiple dose
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of dosing in the second 28-Day cycle of therapy
Observed minimum plasma concentration (C ss,min) after multiple dose
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of dosing in the second 28-Day cycle of therapy
Time to reach maximum plasma concentration (Tmax) after the first dose
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 first dose
Time to reach maximum plasma concentration (T ss,max) after multiple dose
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 of dosing in the second 28-Day cycle of therapy
Apparent terminal half-life (t1/2) after the first dose
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 first dose
Area under plasma concentration versus time curve from zero to the 12 hour sampling time (AUC0-12) after single dose
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours post-dose on Day 1 first dose
Area under plasma concentration versus time curve from zero to the 24 hour sampling time (AUC0-24) after single dose
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1 single dose
Objective response rate (ORR)- Part1
Time frame: From first dose until disease progression or withdrawal from study, assessed up to 24 months.
Disease control rate (DCR)
Time frame: From first dose until disease progression or withdrawal from study, assessed up to 24 months.
Duration of response (DoR)
Time frame: From first dose until disease progression or withdrawal from study, assessed up to 24 months.
Progression-free survival (PFS)
Time frame: From first dose until disease progression or withdrawal from study, assessed up to 24 months.
Overall survival (OS)-Part 2
Time frame: From first dose until disease progression or withdrawal from study, assessed up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
Related trials for Non Small Cell Lung Cancer
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
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
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
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Shun Lu, MD principal investigator
Shanghai Chest Hospital
Jiahua Chen, MD principal investigator
Hunan Cancer Hospital
Xiaorong Dong, MD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10241 in people with Non Small Cell Lung Cancer, run by Jiangsu Hansoh Pharmaceutical 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 16 inclusion and 48 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 14 Feb 2023. 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 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.
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 Shun Lu, MD (86-21-22200000, shun_lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part1-To determine the maximum tolerated dose (MTD) (time frame: Up to day 28 from the first dose (4 weeks).). The study lists 2 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 14 Feb 2023.