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HCCPhase 2YH001NCT05212922

A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC

A Phase 2 study testing YH001 + Toripalimab in people with HCC and NSCLC Stage IIIB, run by Eucure (Beijing) Biopharma Co., Ltd at 22 sites in 5 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an Open-label, Non-Randomized, Multi-center Phase 2 study of YH001 in Combination with Toripalimab，The study is designed to determine the safety ，tolerability and antitumor activity of YH001 in combination with Toripalimab in subjects with advanced NSCLC and HCC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HCC, NSCLC Stage IIIB, NSCLC Stage IV
What is being tested?
YH001 + Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
22 sitesin 5 countries
Study dates
Jun 2023to Mar 2025
Phase
Phase 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

  • Male or female, aged ≥ 18 years；
  • Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
  • Target Population
  • Cohort A:
  • Have histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous)
  • Recurrent or unresectable locally advanced (Stage IIIB) or metastatic (Stage IV);
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  • Naïve to any systemic anti-cancer therapy
  • No EGFR mutation or ALK/ ROS1 gene rearrangement
  • PD-L1 positive (TPS≥1%) NSCLC
  • Cohort B:
  • HCC diagnosis confirmed by or radiology, histology, or cytology;
  • Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy and not amenable to a curative treatment approach;
  • Child-Pugh A liver score within 7 days prior to first dose of study drug;
  • Documented objective radiographic progression during or after treatment with sorafenib/lenvatinib, or intolerant of sorafenib/lenvatinib; or documented objective radiographic progression during or after treatment with atezolizumab and bevacizumab, or intolerant of atezolizumab and bevacizumab.
  • At least 1 unidimensional measurable target lesion per RECIST v1.1
  • ECOG performance status score 0 or 1
  • Have life expectancy of at least 12 weeks based on investigator's judgement.
  • Adequate organ and bone marrow function:
  • Women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -HCG) pregnancy test within 7 days of the fist dose of YH001.
  • Women of reproductive potential who are sexually active with a non-sterilized male must consistently use highly effective contraception/birth control between signing of the informed consent and 120 days after the last administration of the study drug.

Who cannot join

  • Treatment with any investigational drug within 4 weeks prior to the fist dose of study drug；
  • Prior anticancer therapy:
  • Cohort B: Subjects received sorafenib/lenvatinib within 14 days of first dose of study medication.
  • Prior palliative radiotherapy to bone metastases ≤ 2 weeks prior to the first dose of YH001 is acceptable.
  • It is unacceptable to have wash out less than 2 weeks for herbal therapy approved for anticancer.
  • Subjects with prior anti-CTLA-4 checkpoint inhibitors should be excluded.
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  • Subjects with a history of ≥ Grade 3 immune-related adverse events resulted from previous immunotherapy or an AE of any grade that resulted in discontinuation of prior immunotherapy
  • History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis, or history of interstitial lung disease
  • Subjects requiring systemic treatment with corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 21 days before the planned first dose of study drug or has need to be treated while on trial
  • Allergic to YH001 and Toripalimab or any component of the study drug formulation.
  • Subjects with concomitant active autoimmune disease, history of autoimmune disease requiring systemic treatment, or history of autoimmune disease within the two years prior to study entry.
  • Primary central nervous system (CNS) malignancies or symptomatic CNS metastases.
  • Subjects with severe cardiovascular diseases, e.g. New York Heart Association (NYHA) Class III or IV heart failure, myocardial infection within 6 months prior to first dose of YH001, uncontrolled hypertension, unstable angina pectoris or unstable cardiac arrhythmia.
  • QTcF > 470 ms at baseline; no concomitant medications that would prolong the QT interval; no family history of long QT syndrome.
  • Viral infection:
  • Acute or Chronic active Hepatitis B (HBsAg positive and HBV DNA≥2000 IU/mL).
  • Chronic HCV infection (HCV antibody positive and HCV RNA detectable).
  • Human immunodeficiency virus (HIV) infection as well as COVID-19.
  • Subjects with active tuberculosis are excluded. Subjects who have received BCG vaccination may have a false positive PPD test. These subjects are eligible if they have a negative Interferon Gamma Release Assay (IGRA).
  • Clinically uncontrolled concurrent illnesses, including, but not limited to, active infection that requires systematic treatment, serious diabetes (fasting blood glucose > 250 mg/dl), psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies.
  • Continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ Grade 1 per CTCAE v5.0
  • Failure to recover adequately, as judged by the investigator, from prior surgical procedures; the subjects have had major surgery within 28 days, or minor surgery within 2 weeks prior to the first dose of YH001.
  • Subjects received any live or attenuated vaccine within 28 days prior to the first dosing of study drug. For inactivated or attenuated COVID -19 vaccine, follow local guidelines.
  • Pregnant or breast-feeding females.
  • Any clinically significant abnormality in the laboratory
  • Subjects have another active invasive malignancy within 5 years
  • Cohort B:
  • History of esophageal or gastric variceal bleeding within the last 6 months, or current active gastrointestinal bleeding;
  • Large tumor lesion in liver (≥60% liver volum), portal vein invasion at the main portal branch (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging;
  • Clinically diagnosed hepatic encephalopathy in the last 6 months

Trial locations and contacts

22 sites in 5 countries.

22 sites in 5 countries

China11 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102218

  • Bethune First Hospital Of Jilin University

    Changchun, Jilin, 130021

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044

  • Sir Run Run Shaw Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310000

  • The Affiliated Tumour Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226361

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430062

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

Taiwan7 sites

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 40447

  • Chi Mei Medical Center - YongKang

    Tainan, 71004

  • Chi Mei Medical Center - Liouying

    Tainan, 736

  • Taipei Medical University Hospital

    Taipei, 11031

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Australia2 sites

  • Andrew Love Cancer Centre

    Geelong, Victoria, 3220

  • University of New South Wales (UNSW) - Liverpool Hospital

    Liverpool, New South Wales, 2170

Other trials in Australia

Armenia1 site

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

Other trials in Armenia

Austria1 site

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales, 2450

Other trials in Austria

About this study

Official title: An Open-Label, Non-Randomized, Multi-center Phase 2 Study of YH001 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) and Hepatocellular Carcinoma (HCC)

This is an Open-label, Non-Randomized, Multi-center Phase 2 study of YH001 in Combination with Toripalimab，The study is designed to determine the safety ，tolerability and antitumor activity of YH001 in combination with Toripalimab in subjects with advanced NSCLC and HCC.

Read the detailed description

This study will include two cohorts of up to 40 subjects each treated with RP2D dose YH001 in combination with 240 mg Toripalimab to assess the antitumor activity and safety/tolerability.

According to Simon's two stage design, in the first stage, 9-10 subjects will be accrued. If there are ≤ 1 subjects achieving an objective response, the futility stop will be called. Enrollment will start for the second stage after Stage 1 data pass futility test. In the second stage, 17-19 subjects will be enrolled to have 27 subjects in total. If there are ≥ 5 subjects achieving an objective response, a stop could be called for meeting the primary objective.

In all cohorts, 4 mg/kg or other higher dose level of YH001 (not exceeding MTD) may be needed based on the safety data in the first stage.

  • Cohort A: YH001 in combination with Toripalimab in subjects with advanced PD-L1 positive NSCLC as 1st line treatment;
  • Cohort B: YH001 in combination with Toripalimab in subjects with previously systemically treated advanced HCC as 2nd line treatment;
Being tested
YH001 + Toripalimab
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.

  • YH001 + ToripalimabDrug

    YH001 + Toripalimab

Study groups in NCT05212922
Study groupRoleWhat they receive
YH001 + ToripalimabExperimentalThis study will include two cohorts of up to 40 subjects each treated with RP2D dose of YH001 in combination with 240 mg Toripalimab to assess the antitumor activity and safety/tolerability.
Receives: Drug: YH001 + Toripalimab

What is being measured

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

  1. ORR

    Overall Response Rate (ORR) by investigator's assessment according to the RECIST v1.1

    Measured: maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

Secondary outcomes (5)

  1. safety and tolerability

    The safety and tolerability will be assessed by monitoring the adverse events (AE) per NCI CTCAE v5.0

    Measured: maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

  2. OS

    To assess other antitumor activity of YH001 in combination with Toripalimab

    Measured: maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

  3. anti-drug antibodies (ADA)

    Immunogenicity

    Measured: maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

  4. neutralizing antibodies (NAbs).

    To assess the immunogenicity of YH001 in combination with Toripalimab

    Measured: maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

  5. peak concentration (Cmax)

    To characterize the pharmacokinetic (PK) profiles of YH001 in combination with Toripalimab

    Measured: maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.

Timeline

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

  1. First posted28 Jan 2022
  2. Study startJun 2023 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionMar 2025 (estimated)

Why it stopped: Sponsor Decision

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignmen
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05212922
Sponsor's protocol ID
YH001004
Acronym
YH001
Status last verified
Nov 2022
First submitted
30 Nov 2021
Last updated
20 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YH001 + Toripalimab in people with HCC and NSCLC Stage IIIB, run by Eucure (Beijing) Biopharma Co., Ltd at 22 sites in 5 countries.

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 20 inclusion and 30 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: withdrawn, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China, Taiwan, Australia, Armenia, Austria. 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 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: maximum of 1 years after the first dose of YH001 and Toripalimab study treatment.). 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 NCT05212922.

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 20 Mar 2023.

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