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Solid TumorsPhase 1HS-20117NCT06621563

Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors

A Phase 1 study testing HS-20117 combined HS-20093, HS-20117 combined Platinum-containing chemotherapy and HS-20117 combined HS-20093 and 5-FU in people with Solid Tumors and Non-Small Cell Lung Cancer, run by Hansoh BioMedical R&D Company at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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, efficacy, PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
HS-20117 combined HS-20093, HS-20117 combined Platinum-containing chemotherapy and HS-20117 combined HS-20093 and 5-FU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
780 participants
Where
1 siteChina
Study dates
14 Dec 2024to 1 Dec 2026
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).
  • Histologically confirmed unresectable, recurrent or metastatic solid tumors.
  • 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.
  • Signed Informed Consent Form.

Who cannot join

  • Received or are receiving the following treatments:
  • Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-drug conjugates.
  • Monoclonalor bispecific antibodies targeting EGFR.
  • Systemic anti-cancer treatment (Cytotoxicities and anti-cancer Traditional Chinese medicine or TKIs) within 2 weeks prior to the first dose of HS-20117.
  • Investigational anti-cancer drugs or antibodies or ADCs 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.
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  • 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.
  • Presence of uncured secondary primary malignancies.
  • Untreated, or active central nervous system metastases.
  • Severe, uncontrolled or active cardiovascular disorders.
  • Serious infection within 4 weeks prior to the first dose of HS-20117.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaowei Yan contact

13061877102

yanxw@hspharm.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Recruiting

Other trials in China

About this study

Official title: Safety, Tolerability, Efficacy, Pharmacokinetics Profile and Immunogenicity of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors, a Phase Ib Clinical Trial

HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors.

Read the detailed description

This is a multicenter, open-label, Phase Ib clinical trial of HS-20117 combination therapies to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity in participants with advanced solid tumors. The study includes a dose escalation part and a dose expansion part. The dose-escalation study will be performed to evaluate the safety, tolerability, PK profile, immunogenicity, and efficacy of HS-20117 combination therapies in participants with advanced solid tumor. The subsequent dose-expansion study will be performed to evaluate the efficacy of HS-20117 combination therapies in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations or EGFR classical mutations, and RAS/BRAF V600E wild type CRC.

Being tested
HS-20117 combined HS-20093, HS-20117 combined Platinum-containing chemotherapy, HS-20117 combined HS-20093 and 5-FU, HS-20117+CAPEOX, HS-20117+FOLFIRI
Keywords
Solid tumor, EGFR/c-MET bispecific antibody, B7H3 ADC, chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-20117 combined HS-20093Drug

    HS-20117 + HS-20093

  • HS-20117 combined Platinum-containing chemotherapyDrug

    HS-20117 + cisplatin/carboplatin + pemetrexed

  • HS-20117 combined HS-20093 and 5-FUDrug

    HS-20117 + HS-20093 + 5-FU

  • HS-20117+CAPEOXDrug

    CAPOEX: Oxaliplatin+Capecitabine

  • HS-20117+FOLFIRIDrug

    FOLFIRI=Irinotecan+Leucovorin Calcium+5-FU

  • HS-20117+mFOLFOX6Drug

    mFOLFOX6=Oxaliplatin+Leucovorin Calcium+5-FU

Study groups in NCT06621563
Study groupRoleWhat they receive
Cohort 1aExperimentalNSCLC
Receives: Drug: HS-20117 combined Platinum-containing chemotherapy
Cohort 2aExperimentalNSCLC
Receives: Drug: HS-20117 combined HS-20093
Cohort 3aExperimentalCRC
Receives: Drug: HS-20117+CAPEOX
Cohort 4aExperimentalCRC
Receives: Drug: HS-20117+FOLFIRI
Cohort 5aExperimentalCRC
Receives: Drug: HS-20117+mFOLFOX6
Cohort 6aExperimentalCRC
Receives: Drug: HS-20117 combined HS-20093 and 5-FU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: rom the date of first dose to 90 days after the final dose.

  2. Tolerability of HS-20117 combination therapy: incidence of DLT events, maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20117 in combination therapies.

    MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT. 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: From the date of first dose to day 21.

Secondary outcomes (10)

  1. 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 to the date of disease progression or withdrawal from study, approximately 2 years

  2. 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 to the date of disease progression or withdrawal from study, approximately 2 years

  3. 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 first dose to the date of disease progression or withdrawal from study, approximately 2 years

  4. 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 first dose to the date of disease progression or withdrawal from study, approximately 2 years

  5. 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 first dose to the date of disease progression or withdrawal from study, approximately 2 years

  6. PK parameters: Trough serum concentration (Ctrough) of HS-20117 and HS-20093

    Ctrough is the observed serum concentration immediately prior to the next administration.

    Measured: From the date of first dose to 90 days after the final dose.

  7. 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 to 90 days after the final dose.

  8. 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 to 90 days after the final dose.

  9. PK parameters: Maximum serum concentration (Cmax) of HS-20117 and HS-20093.

    The Cmax is the maximum observed serum concentration of HS-20117, HS-20093.

    Measured: From the date of first dose to 90 days after the final dose.

  10. Immunogenicity of HS-20117

    Immunogenicity will be measured by the number of participants that are ADA positive.

    Measured: From the date of first dose to 90 days after the final dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start14 Dec 2024
  3. Primary completion30 Mar 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
780 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06621563
Sponsor's protocol ID
HS-20117-102
Acronym
HS-20117
Status last verified
Apr 2025
First submitted
29 Sep 2024
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-20117 combined HS-20093, HS-20117 combined Platinum-containing chemotherapy and HS-20117 combined HS-20093 and 5-FU in people with Solid Tumors and Non-Small Cell Lung Cancer, 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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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 Xiaowei Yan (13061877102, yanxw@hspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of treatment-emergent adverse events (time frame: rom the date of first dose to 90 days after the final dose.). 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?

On the ClinicalTrials.gov record for NCT06621563.

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 9 Apr 2025.

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