Non-Small Cell Lung CancerPhase 1NCT05940116
A Phase I Clinical Study of HS-20117 in Participants With Advanced Solid Tumors
A Phase 1 study testing HS-20117 in people with Non-Small Cell Lung Cancer and Solid Tumor, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HS-20117 as a monotherapy for participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Solid Tumor
- What is being tested?
- HS-20117
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2023to 30 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18 - 75 years (inclusive).
- For the phase Ia study: Participants with locally advanced or metastatic NSCLC (stage IIIB/IIIC/IV) with EGFR-activating mutations who have progressed after or are intolerant to or not available to standard of care (SoC).
- For the phase Ib study:
- Cohort A: Participants with locally advanced or metastatic NSCLC (stage IIIB/IIIC/IV) with EGFR exon 20ins mutations who have progressed after prior platinum-based chemotherapy or are intolerant to platinum-based chemotherapy.
- Cohort B: Participants with other advanced solid tumors who have progressed after prior SoC or are intolerant to SoC.
- Agree to provide fresh or archival tumor tissue.
Show all 12Show fewer
- At least one target lesion per the RECIST v1.1.
- ECOG performance status of 0-1.
- Minimum life expectancy > 12 weeks.
- Males or Females should be using adequate contraceptive measures throughout the study.
- Females must not be pregnant at screening or have evidence of non-childbearing potential.
- Have signed Informed Consent Form.
Who cannot join
- Received or are receiving the following treatments:
- For the phase Ib study Cohort A: Previous or current treatment with EGFR exon 20ins targeted therapy.
- Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of HS-20117.
- Cytotoxic chemotherapies, investigational drugs or other systematic anti-tumor therapies within 3 weeks prior to the first dose of HS-20117.
- Antibodies within 4 weeks prior to the first dose of HS-20117.
- Local radiotherapy within 2 weeks prior to the first dose of HS-20117, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of HS-20117.
Show all 22Show fewer
- Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
- Major surgery within 4 weeks prior to the first dose of HS-20117.
- Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
- History of other primary malignancies.
- Untreated, or active central nervous system metastases.
- Inadequate bone marrow reserve or organ functions.
- Severe, uncontrolled or active cardiovascular disorders.
- Severe or uncontrolled systemic diseases.
- Severe bleeding symptoms or bleeding tendencies within 1 month prior to the first dose of HS-20117.
- Severe arteriovenous thrombosis occurred within 3 months prior to the first dose of HS-20117
- Serious infection within 4 weeks prior to the first dose of HS-20117.
- Active infectious diseases.
- Interstitial lung disease (ILD).
- Serious neurological or mental disorders.
- History of hypersensitivity to any component of HS-20117 or similar drugs.
- Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300181
Lin Jiang, +86 022-23340123 ext. 6417, jianglinchn@163.com
Dingzhi Huang, Dr.
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20117 in Participants With Advanced Solid Tumors
HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HS-20117 as a monotherapy for participants with advanced solid tumors.
Read the detailed description
This is a multicenter, open-label, Phase I clinical study of HS-20117 to evaluate the safety, tolerability, PK, immunogenicity and efficacy in participants with advanced solid tumors. The study consists of phase Ia (dose escalation) and phase Ib (dose expansion). The dose-escalation study will be performed to evaluate the safety, tolerability, PK profile, immunogenicity, and efficacy of HS-20117 in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. The subsequent dose-expansion study will be performed to evaluate the efficacy of HS-20117 in participants with locally advanced or metastatic NSCLC who have progressed after prior platinum-based chemotherapy or are intolerant to platinum-based chemotherapy with EGFR exon 20 insertion mutations, and to explore the efficacy of HS-20117 in participants with other advanced solid tumors.
- Conditions
- Non-Small Cell Lung Cancer, Solid Tumor
- Being tested
- HS-20117
- Keywords
- Non-Small Cell Lung Cancer, Solid Tumor, HS-20117, Epidermal Growth Factor Receptor, c-Mesenchymal-Epithelial Transition, Bispecific Antibody, EGFR exon 20 insertion
- 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-20117Drug
Also called PM1080
Phase Ia: patients will receive HS-20117 starting at 400 mg, and subsequent cohorts will test escalating doses, if tolerated, until a maximum tolerated dose (MTD) or maximum applicable dose (MAD) is defined.
Phase Ib: patients will receive HS-20117 at MED or MAD
| Study group | Role | What they receive |
|---|---|---|
| HS-20117 | Experimental | Participants will receive IV infusion of HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days) Receives: Drug: HS-20117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Phase 1a] Maximum tolerated dose (MTD) of HS-20117
MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT.
Measured: Cycle 1 (28 days)
[Phase 1a] Maximum applicable dose (MAD) of HS-20117
MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.
Measured: Cycle 1 (28 days)
[Phase 1b] Efficacy of HS-20117: Objective response rate (ORR)
ORR is defined as the percentage of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
Secondary outcomes (12)
[phase 1a and 1b] Incidence and severity of treatment-emergent adverse events
Adverse event (assessed according to NCI CTCAE v5.0) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: From the date of first dose until 90 days after the final dose. A cycle is 28 days
[phase 1a and 1b] PK parameters: Maximum serum concentration (Cmax) of HS-20117
The Cmax is the maximum observed serum concentration of HS-20117.
Measured: From the date of first dose until 30 days after the final dose. A cycle is 28 days.
[phase 1a and 1b] PK parameters: Trough serum concentration (Ctrough) of HS-20117
Ctrough is the observed serum concentration immediately prior to the next administration.
Measured: From the date of first dose until 30 days after the final dose. A cycle is 28 days.
[phase 1a and 1b] PK parameters: Time to reach maximum observed serum concentration (Tmax) of HS-20117
The Tmax is defined as time to reach maximum observed serum concentration of HS-20117.
Measured: From the date of first dose until 30 days after the final dose. A cycle is 28 days
[phase 1a] PK parameters: Area under the curve from time Zero to end of dosing interval (AUCtau) of HS-20117
The AUCtau is defined as the area under the serum concentration-time curve during a dose interval time period (tau).
Measured: From the date of first dose until 30 days after the final dose. A cycle is 28 days.
[phase 1a] PK parameters: Terminal elimination half-life (t1/2) of HS-20117
The t1/2 is defined as the time it takes for the concentration levels to fall to 50% of their value.
Measured: From the date of first dose until 30 days after the final dose. A cycle is 28 days.
[phase 1a] Efficacy of HS-20117: ORR
ORR is defined as the percentage of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1.
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years.
[phase 1a and 1b] Efficacy of HS-20117: disease control rate (DCR)
DCR is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 6 weeks) per RECIST v1.1.
Measured: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years.
[phase 1a and 1b] Efficacy of HS-20117: duration of response (DoR)
DoR only applies to participants whose best overall response is CR or PR based on assessment per RECIST v1.1. The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying disease.
Measured: From the date of CR, PR until the date of disease progression or death, approximately 2 years.
[phase 1a and 1b] Efficacy of HS-20117: progression free survival (PFS)
PFS is defined as the time from the date of randomization or first dose (if randomization is not needed) to the date of the first documented progression or death due to any cause. PFS will be assessed per RECIST v1.1.
Measured: From the date of randomization or first dose (if randomization is not needed) until the date of disease progression or death, approximately 2 years.
[phase 1b] Efficacy of HS-20117: overall survival (OS)
OS is defined as the time from the date of randomization or first dose (if randomization is not needed) to the date of death due to any cause. For each participant who is not known to have died as of the cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Measured: From the date of randomization or first dose (if randomization is not needed) until the documentation of death from any cause, approximately 4 years
[phase 1a and 1b] Immunogenicity of HS-20117
Immunogenicity will be measured by the number of participants that are ADA positive.
Measured: Cycle 1 Day 1: predose through EOT or follow up period (90 days after the last dose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start20 Jul 2023 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2027 (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 Hansoh BioMedical R&D CompanyThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dingzhi Huang, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940116
- Sponsor's protocol ID
- HS-20117-101
- Status last verified
- Jul 2023
- First submitted
- 26 Jun 2023
- Last updated
- 12 Jul 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 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20117 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05940116
- Acronym / sponsor ID
- HS-20117-101
- Conditions
- Non-Small Cell Lung Cancer, Solid Tumor
- Keywords
- Non-Small Cell Lung Cancer, Solid Tumor, HS-20117, Epidermal Growth Factor Receptor, c-Mesenchymal-Epithelial Transition, Bispecific Antibody, EGFR exon 20 insertion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2023 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 11 Jul 2023 (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.
HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HS-20117 as a monotherapy for participants with advanced solid tumors.
Detailed description
This is a multicenter, open-label, Phase I clinical study of HS-20117 to evaluate the safety, tolerability, PK, immunogenicity and efficacy in participants with advanced solid tumors. The study consists of phase Ia (dose escalation) and phase Ib (dose expansion). The dose-escalation study will be performed to evaluate the safety, tolerability, PK profile, immunogenicity, and efficacy of HS-20117 in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. The subsequent dose-expansion study will be performed to evaluate the efficacy of HS-20117 in participants with locally advanced or metastatic NSCLC who have progressed after prior platinum-based chemotherapy or are intolerant to platinum-based chemotherapy with EGFR exon 20 insertion mutations, and to explore the efficacy of HS-20117 in participants with other advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-20117 | Experimental | Drug: HS-20117Participants will receive IV infusion of HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males or females aged 18 - 75 years (inclusive).
- For the phase Ia study: Participants with locally advanced or metastatic NSCLC (stage IIIB/IIIC/IV) with EGFR-activating mutations who have progressed after or are intolerant to or not available to standard of care (SoC).
- For the phase Ib study:
- Cohort A: Participants with locally advanced or metastatic NSCLC (stage IIIB/IIIC/IV) with EGFR exon 20ins mutations who have progressed after prior platinum-based chemotherapy or are intolerant to platinum-based chemotherapy.
- Cohort B: Participants with other advanced solid tumors who have progressed after prior SoC or are intolerant to SoC.
Key exclusion criteria (22 listed)
- Received or are receiving the following treatments:
- Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
- History of other primary malignancies.
- Untreated, or active central nervous system metastases.
- Inadequate bone marrow reserve or organ functions.
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-20117Also: PM1080Phase Ia: patients will receive HS-20117 starting at 400 mg, and subsequent cohorts will test escalating doses, if tolerated, until a maximum tolerated dose (MTD) or maximum applicable dose (MAD) is defined. Phase Ib: patients will receive HS-20117 at MED or MAD | Drug | HS-20117 |
Primary outcome
[Phase 1a] Maximum tolerated dose (MTD) of HS-20117
Time frame: Cycle 1 (28 days)
MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT.
[Phase 1a] Maximum applicable dose (MAD) of HS-20117
Time frame: Cycle 1 (28 days)
MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.
[Phase 1b] Efficacy of HS-20117: Objective response rate (ORR)
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
ORR is defined as the percentage of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1
12 secondary outcomes
[phase 1a and 1b] Incidence and severity of treatment-emergent adverse events
Time frame: From the date of first dose until 90 days after the final dose. A cycle is 28 days
[phase 1a and 1b] PK parameters: Maximum serum concentration (Cmax) of HS-20117
Time frame: From the date of first dose until 30 days after the final dose. A cycle is 28 days.
[phase 1a and 1b] PK parameters: Trough serum concentration (Ctrough) of HS-20117
Time frame: From the date of first dose until 30 days after the final dose. A cycle is 28 days.
[phase 1a and 1b] PK parameters: Time to reach maximum observed serum concentration (Tmax) of HS-20117
Time frame: From the date of first dose until 30 days after the final dose. A cycle is 28 days
[phase 1a] PK parameters: Area under the curve from time Zero to end of dosing interval (AUCtau) of HS-20117
Time frame: From the date of first dose until 30 days after the final dose. A cycle is 28 days.
[phase 1a] PK parameters: Terminal elimination half-life (t1/2) of HS-20117
Time frame: From the date of first dose until 30 days after the final dose. A cycle is 28 days.
[phase 1a] Efficacy of HS-20117: ORR
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years.
[phase 1a and 1b] Efficacy of HS-20117: disease control rate (DCR)
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years.
[phase 1a and 1b] Efficacy of HS-20117: duration of response (DoR)
Time frame: From the date of CR, PR until the date of disease progression or death, approximately 2 years.
[phase 1a and 1b] Efficacy of HS-20117: progression free survival (PFS)
Time frame: From the date of randomization or first dose (if randomization is not needed) until the date of disease progression or death, approximately 2 years.
[phase 1b] Efficacy of HS-20117: overall survival (OS)
Time frame: From the date of randomization or first dose (if randomization is not needed) until the documentation of death from any cause, approximately 4 years
[phase 1a and 1b] Immunogenicity of HS-20117
Time frame: Cycle 1 Day 1: predose through EOT or follow up period (90 days after the last dose).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 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.
Dingzhi Huang principal investigator
Tianjin Medical University Cancer Institute and Hospital
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-20117 in people with Non-Small Cell Lung Cancer and Solid Tumor, run by Hansoh BioMedical R&D Company 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 12 inclusion and 22 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: opening soon, as of the sponsor's last update on 12 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Zhou (+86 18013002767, zhoup7@hspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Phase 1a] Maximum tolerated dose (MTD) of HS-20117 (time frame: Cycle 1 (28 days)). 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 12 Jul 2023.