Locally Advanced or Metastatic Solid TumorsPhase 1NCT05360381
HLX35(EGFR×4-1BB Bispecific) in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing HLX35 in people with Locally Advanced or Metastatic Solid Tumors and Squamous-cell Non-small Cell Lung Cancer, run by Shanghai Henlius Biotech at 2 sites in China.
Trial summary
This Phase1, multicenter, first-in-human, open-label, dose-escalation, and dose expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX35 administered as a single-agent by IV infusion every 2 weeks to patients with locally advanced or metastatic solid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors, Squamous-cell Non-small Cell Lung Cancer
- What is being tested?
- HLX35
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesChina
- Study dates
- 3 Jun 2022to 30 Dec 2024
- 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 this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
- Age ≥ 18 years;
- Phase 1a dose escalation: patients must have histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
- Phase 1b dose expansion: patients must have a histological or cytological diagnosis of Squamous Non-Small Cell Lung Cancer (EGFR H score ≥200 confirmed by central lab) which is advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
- Measurable disease according to RECIST Version 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- Expected survival 12 weeks;
- Adequate organ function;
Who cannot join
- Systemic anti-cancer treatment or investigational agents in the 28 days prior to the first study dosing;
- Patients who still have persistent ≥ grade 2 toxicities from prior therapies;
- Active CNS metastasis;
- History of any secondary malignancy in the past 5 years;
- Active autoimmune disease;
- Human immunodeficiency virus (HIV) infection;
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fudan University Shanghai Cancer Center
Shanghai, 200000
THE Affiliated Hospital of Xuzhou Medical University
Xuzhou
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Initial Efficacy of HLX35 (Recombinant Human Anti-EGFR and Anti-4-1BB Bispecific Antibody) in Patients With Advanced or Metastatic Solid Tumors
This Phase1, multicenter, first-in-human, open-label, dose-escalation, and dose expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX35 administered as a single-agent by IV infusion every 2 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. This study has two parts: phase 1a dose escalation and phase 1b dose expansion.
- Being tested
- HLX35
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX35Drug
A Recombinant Human Anti-EGFR and Anti-4-1BB Bispecific Antibody, HLX35 will be administered as a single intravenous (IV) infusion on Day 1 in each 14-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a dose-escalation stage | Experimental | Phase 1a uses the "3+3" design, to investigate the safety and determine the MTD of HLX35. Seven dose levels of 0.015 mg/kg, 0.05 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg are planned for dose finding. Enrollment will continue until a maximum of 42 patients are enrolled Receives: Drug: HLX35 |
| Phase 1b dose-expansion stage | Experimental | Patients with sqNSCLC (EGFR H score≥200) will be enrolled in two expansion cohorts, at doses equal to or lower than the MTD, to better characterize the safety, tolerability, PK variability, and preliminary efficacy of single-agent HLX35. Phase 1b dose expansion will include 15-20 per-protocol treated patients, as defined above, in each of the two expansion cohorts. Receives: Drug: HLX35 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Related Adverse Events
Measured: 2 years
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)
The maximum tolerated dose (MTD)
Measured: from first dose to the end of Cycle 2 (each cycle is 14 days)
Recommended phase 2 dose (RP2D)
Measured: from first dose to the end of Cycle 2 (each cycle is 14 days)
Secondary outcomes (13)
Peak plasma concentration (Cmax) of HLX35
Measured: 2 years
Time to peak (Tmax) of HLX35
Measured: 2 years
Area under the concentration-time curve (AUC) of HLX35
Measured: 2 years
Elimination half-life (t1/2) of HLX35
Measured: 2 years
Clearance (CL) of HLX35
Measured: 2 years
Volume of distribution (Vz) of HLX35
Measured: 2 years
Accumulation Index (Rac) of HLX35
Measured: 2 years
4-1BB receptor occupancy on circulating T cells
Measured: 2 years
The level of 4-1BB in serum
Measured: 2 years
Incidence of treatment-emergent anti-drug antibodies (ADA)
Measured: 2 years
Objective response rate (ORR)
Measured: 2 years
Disease control rate (DCR)
Measured: 2 years
Duration of response (DOR)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start3 Jun 2022
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360381
- Sponsor's protocol ID
- HLX35-FIH101
- Status last verified
- Aug 2023
- First submitted
- 26 Apr 2022
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Initial Efficacy of HLX35 (Recombinant Human Anti-EGFR and Anti-4-1BB Bispecific Antibody) in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05360381
- Acronym / sponsor ID
- HLX35-FIH101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 4 May 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 Phase1, multicenter, first-in-human, open-label, dose-escalation, and dose expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX35 administered as a single-agent by IV infusion every 2 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. This study has two parts: phase 1a dose escalation and phase 1b dose expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a dose-escalation stage | Experimental | Drug: HLX35Phase 1a uses the "3+3" design, to investigate the safety and determine the MTD of HLX35. Seven dose levels of 0.015 mg/kg, 0.05 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg are planned for dose finding. Enrollment will continue until a maximum of 42 patients are enrolled |
| Phase 1b dose-expansion stage | Experimental | Drug: HLX35Patients with sqNSCLC (EGFR H score≥200) will be enrolled in two expansion cohorts, at doses equal to or lower than the MTD, to better characterize the safety, tolerability, PK variability, and preliminary efficacy of single-agent HLX35. Phase 1b dose expansion will include 15-20 per-protocol treated patients, as defined above, in each of the two expansion cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
- Age ≥ 18 years;
- Phase 1a dose escalation: patients must have histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
- Phase 1b dose expansion: patients must have a histological or cytological diagnosis of Squamous Non-Small Cell Lung Cancer (EGFR H score ≥200 confirmed by central lab) which is advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
- Measurable disease according to RECIST Version 1.1;
Key exclusion criteria (6 listed)
- Systemic anti-cancer treatment or investigational agents in the 28 days prior to the first study dosing;
- Patients who still have persistent ≥ grade 2 toxicities from prior therapies;
- Active CNS metastasis;
- History of any secondary malignancy in the past 5 years;
- Active autoimmune disease;
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 |
|---|---|---|
| HLX35A Recombinant Human Anti-EGFR and Anti-4-1BB Bispecific Antibody, HLX35 will be administered as a single intravenous (IV) infusion on Day 1 in each 14-day cycle | Drug | Phase 1a dose-escalation stage, Phase 1b dose-expansion stage |
Primary outcome
Incidence of Treatment-Related Adverse Events
Time frame: 2 years
The proportion of patients experiencing dose limiting toxicity (DLT) events
Time frame: from first dose to the end of Cycle 2 (each cycle is 14 days)
The maximum tolerated dose (MTD)
Time frame: from first dose to the end of Cycle 2 (each cycle is 14 days)
Recommended phase 2 dose (RP2D)
Time frame: from first dose to the end of Cycle 2 (each cycle is 14 days)
13 secondary outcomes
Peak plasma concentration (Cmax) of HLX35
Time frame: 2 years
Time to peak (Tmax) of HLX35
Time frame: 2 years
Area under the concentration-time curve (AUC) of HLX35
Time frame: 2 years
Elimination half-life (t1/2) of HLX35
Time frame: 2 years
Clearance (CL) of HLX35
Time frame: 2 years
Volume of distribution (Vz) of HLX35
Time frame: 2 years
Accumulation Index (Rac) of HLX35
Time frame: 2 years
4-1BB receptor occupancy on circulating T cells
Time frame: 2 years
The level of 4-1BB in serum
Time frame: 2 years
Incidence of treatment-emergent anti-drug antibodies (ADA)
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX35 in people with Locally Advanced or Metastatic Solid Tumors and Squamous-cell Non-small Cell Lung Cancer, run by Shanghai Henlius Biotech at 2 sites 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 6 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Incidence of Treatment-Related Adverse Events (time frame: 2 years). The study lists 4 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 8 Aug 2023.