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Solid Tumor, AdultPhase 1NCT05442996

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX35 in Combination With HLX10 in Patients With Advanced or Metastatic Solid Tumors

A Phase 1 study testing HLX35 and HLX10 in people with Solid Tumor, Adult, run by Shanghai Henlius Biotech.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase I clinical study designed to evaluate the safety, tolerability, PK characteristics, and preliminary efficacy of HLX35 in combination with HLX10 in patients with advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Adult
What is being tested?
HLX35 and HLX10
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
6 Jan 2023to 22 Apr 2025
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

  • Volunteer to participate in the clinical study; be able to sign the ICF based on full understanding and awareness of the study; have the willingness to follow and the capacity to complete all trial procedures;
  • Aged ≥ 18 years at the time of signing the ICF;
  • Advanced or metastatic solid malignancies confirmed cytologically or histopathologically, prior failure of standard therapy, free of standard therapy or intolerant of standard therapy;
  • Interval between completion of prior systemic anti-tumor treatment (chemotherapy, targeted therapy, and immunotherapy) and the first dose in this study is ≥ 28 days; interval between completion of endocrine or TCM anti-tumor therapy and the first dose in this study is ≥ 14 days; interval between completion of any other anti-tumor treatment with clinical study drug and the first dose in this study is ≥ 28 days;
  • Prior anti-tumor treatment-related AE recovering to grade ≤ 1 as per CTCAE v5.0 prior to the first dose (except for alopecia);
  • At least one measurable target lesion assessed by the investigator according to the RECIST v1.1 is required within 4 weeks prior to the first dose (Note: Measurable target lesions may not be selected from the previously irradiated site. If a target lesion at a previously irradiated site is the only optional target lesion, the imaging data before and after significant progression of this lesion after radiotherapy completion should be provided);
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  • ECOG performance status score is 0 or 1 within 7 days prior to the first dose;
  • Life expectancy of the patient prior to the first dose judged by the investigator is ≥ 12 weeks;
  • Major organ functions are normal;
  • Women of childbearing potential must complete a serum pregnancy test and have a negative result within 7 days prior to the first dose;
  • Female subjects of childbearing potential or male subjects whose partners are women of childbearing potential must agree to take at least one medically accepted contraceptive measure (intra-uterine device, contraceptive, condom, etc.) from the time of signing the ICF until 6 months after the last dose of the investigational product.

Who cannot join

  • Other active malignancies within 2 years prior to the first dose of investigational product. Localized tumors that have been cured, such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, breast cancer in situ, etc., are acceptable;
  • Patients who are going to receive or have received an organ or bone marrow transplant;
  • Patients with uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (monthly or more frequently);
  • Symptomatic brain or meningeal metastases (unless the patient has been treated for > 3 months, there is no evidence of progression on imaging within 4 weeks prior to the first dose, and the tumor-related clinical symptoms are stable);
  • Patients with cerebrovascular accident, myocardial infarction, unstable angina, poorly controlled arrhythmia (including QTc intervals ≥ 450 ms in males and ≥ 470 ms in females) (QTc intervals are calculated by Fridericia formula) occurring within half a year;
  • A cardiac insufficiency of Grade III or IV according to the New York Heart Association (NYHA) classification (Appendix 6), or a left ventricular ejection fraction (LVEF) < 50% based on echocardiography;
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  • Human immunodeficiency virus (HIV) infection;
  • Positive (+) for hepatitis B surface antigen (HBsAg) or positive (+) for hepatitis B core antibody (HBcAb), with the hepatitis B virus deoxyribonucleic acid (HBV-DNA) ≥2000 copies /ml, or the presence of active hepatitis determined clinically; hepatitis C (positive for HCV antibody and positive for HCV-RNA);
  • Patients with grade 3-4 drug-related hepatitis;
  • Patients with active pulmonary tuberculosis;
  • Patients with prior and current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function, etc. that may interfere with the detection and management of suspected drug-related pulmonary toxicity;
  • Patients with known active or suspected autoimmune diseases. Patients who are allowed to have a history of autoimmune disease at enrollment but with no requirement for systemic immunosuppressive therapy at least 12 months prior to screening;
  • Have received treatment with live vaccines within 28 days prior to the first dose. Patients may receive inactivated viral vaccines for seasonal influenza and 2019-nCoV vaccines, but may not receive live attenuated influenza vaccines via intranasal route;
  • Patients requiring treatment with systemic glucocorticoids (> 10 mg/day prednisone efficacy dose) or other immunosuppressive drugs within 14 days prior to the first dose or during the study. However, patients are allowed to be enrolled under the following conditions: in the absence of active autoimmune disease, patients are allowed to use topical or inhaled glucocorticoids and adrenal glucocorticoids replacement therapy at an effective dose equivalent to ≤ 10 mg/day of prednisone;
  • With any serious infection requiring systemic anti-infective therapy within 14 days prior to the first dose of the investigational product;
  • Major surgery within 28 days prior to the first dose of investigational product. A major surgery is defined as a surgery that takes at least 3 weeks of postoperative recovery before receiving treatment in this study;
  • Prior treatment with antibody drugs against immune checkpoint inhibitors (such as PD-1, PD-L1, and CTLA4) or anti-4-1BB antibody drugs;
  • With a history of severe allergy to any monoclonal antibody or any excipient of the investigational product;
  • Pregnant or lactating women;
  • Known history of psychotropic substance abuse or drug use;
  • Have other conditions not suitable for inclusion as judged by the investigator.

Trial locations and contacts

No sites are listed yet.

Xuhui Hu, MD contact

021-33395800

Xuhui_Hu@henlius.com

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX35 (Recombinant Humanized Anti-EGFR and Anti-4-1BB Bispecific Antibody Injection) in Combination With HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Patients With Advanced or Metastatic Solid Tumors

This is a phase I clinical study designed to evaluate the safety, tolerability, PK characteristics, and preliminary efficacy of HLX35 in combination with HLX10 in patients with advanced or metastatic solid tumors.

Read the detailed description

For HLX35, 5 dose levels are set, starting at 0.1 mg/kg, q2w, followed by gradually escalating doses of 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg; for HLX10, a fixed dose of 200 mg is set, q2w, without dose escalation. The "3 + 3" design is used for dose escalation in this study.

Being tested
HLX35, HLX10

What participants receive

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

  • HLX35Drug

    Also called Recombinant humanized anti-EGFR and anti-4-1BB bispecific antibody injection

    The dose of HLX35 is set at 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg. It is administered intravenously every 2 weeks on day 1 of each cycle.

  • HLX10Drug

    Also called Recombinant humanized anti-PD-1 monoclonal antibody injection

    The dose of HLX10 is fixed at 200 mg. It is administered intravenously once every 2 weeks on day 1 of each cycle.

Study groups in NCT05442996
Study groupRoleWhat they receive
HLX35+HLX10ExperimentalSubjects will receive HLX35 in combination with HLX10 therapy, every 2 weeks as one treatment cycle.
Receives: Drug: HLX35; Drug: HLX10

What is being measured

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

  1. Number of occurrences and incidence of each adverse event (AE)

    Measured: up to 2 years

  2. The proportion of patients experiencing dose limiting toxicity (DLT) events

    Measured: from first dose to the end of Cycle 2 (each cycle is 14 days)

  3. The maximum tolerated dose (MTD)

    Measured: from first dose to the end of Cycle 2 (each cycle is 14 days)

Secondary outcomes (15)

  1. Peak plasma concentration (Cmax)

    Measured: up to 2 years

  2. Time to peak (Tmax)

    Measured: up to 2 years

  3. Area under the concentration-time curve (AUC)

    Measured: up to 2 years

  4. Elimination half-life (t1/2)

    Measured: up to 2 years

  5. Clearance (CL)

    Measured: up to 2 years

  6. Volume of distribution (Vz)

    Measured: up to 2 years

  7. Accumulation Index (Rac)

    Measured: up to 2 years

  8. 4-1BB receptor occupancy of T-cells

    Measured: up to 2 years

  9. soluble 4-1BB level

    Measured: up to 2 years

  10. incidence of anti-HLX35 antibody (ADA) and its neutralizing antibody (NAb)

    Measured: up to 2 years

  11. Objective response rate (ORR)

    Measured: up to 2 years

  12. Disease control rate (DCR)

    Measured: up to 2 years

  13. Duration of response (DOR)

    Measured: up to 2 years

  14. Progression-free survival (PFS)

    Measured: up to 2 years

  15. Overall Survival (OS)

    Measured: up to 2 years

Timeline

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

  1. First posted5 Jul 2022
  2. Study start6 Jan 2023 (estimated)
  3. Primary completion22 Apr 2024 (estimated)
  4. Study completion22 Apr 2025 (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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05442996
Sponsor's protocol ID
HLX35HLX10-101
Status last verified
Jun 2022
First submitted
29 Jun 2022
Last updated
5 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HLX35 and HLX10 in people with Solid Tumor, Adult, run by Shanghai Henlius Biotech.

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 11 inclusion and 21 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 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

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 Xuhui Hu, MD (021-33395800, Xuhui_Hu@henlius.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of occurrences and incidence of each adverse event (AE) (time frame: up to 2 years). 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?

On the ClinicalTrials.gov record for NCT05442996.

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 5 Jul 2022.

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