Advanced Solid TumorPhase 1NCT04797468
A Phase 1 Study of the CD73 Inhibitor(HLX23) Alone in Participants With Solid Tumor
A Phase 1 study testing HLX23 in people with Advanced Solid Tumor, run by Shanghai Henlius Biotech at 6 sites in United States.
Trial summary
The reason for this study is to see if the CD73 inhibitor HLX23 alone is safe and effective in participants with advanced solid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- HLX23
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Jul 2022to 13 Jan 2023
- 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, fully understand the study and have signed the ICF, willing and have the capacity to comply with and complete all trial procedures;
- Aged ≥ 18 years when signing the ICF;
- Patients with advanced or metastatic solid tumors confirmed by histologically or cytologically, who have failed standard treatment, or who do not have standard treatment regimens, or who are not suitable for standard treatment;
- Patients with at least one evaluable lesion assessed as per RECIST1.1 criteria;
- Patients must be able to supply adequate tumor tissue for biomarker (CD73 and CD68 ) analyses;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 when enrolled in the study;
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- Life expectancy longer than three months;
- Adequate hematologic functions;
- Adequate hepatic function ;
- Adequate renal function, as defined by the creatinine clearance rate ≥ 50 mL/minute by Cockcroft-Gault formula;
- Adequate cardiac function ;
- At least 28 days from prior major surgery or medical device or local radiotherapy, at least five half-lives from prior cytotoxic chemotherapy, immunotherapy, biological agents and at least 14 days from prior hormonal therapy and minor surgery before the first infusion of HLX23;
- For patients with hepatocellular carcinoma, the Child-Pugh score has to be A;
- Female participants of childbearing potential and male partners with female partners of childbearing potential must agree to use one adequate and medically approved barrier method of contraception during the study and for at least 6 months after the last dose of the study drugs.
Who cannot join
- Patients who still have ≥ grade 2 toxicities from prior therapies;
- Patients who have history of allergic reaction to monoclonal antibodies;
- Concurrent unstable or uncontrolled medical conditions;
- Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix (patients with previous history of malignancy but without evidence of disease for ≥ 3 years can participate in the study);
- History of prior treatment with anti-CD73 antibodies,including patients treated with adenosine receptor antagonists, CD39 or CD73 inhibitors ;
- Patients with active autoimmune disease, except vitiligo or cured childhood asthma/allergies that requires no intervention after adulthood, autoimmune-mediated hypothyroidism treated with stable doses of thyroid hormone replacement, or Type I diabetes treated with stable doses of insulin can be excepted. Patients in a stable state and do not require systemic immunosuppressive therapy (including corticosteroids) are allowed to be enrolled;
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- Pregnancy or breast-feeding;
- Known history of human immunodeficiency virus infection (HIV), but the patients with CD4+ T-cell (CD4+) counts ≥ 350 cells/uL are allowed to be enrolled.
- hepatitis B virus carrier status (HBV surface antigen positive) and hepatitis C carrier (anti-HCV antibody positive). If HBsAg (+) or HBcAb (+), the HBV-DNA≥2500copy/mL or 500 IU/mL, or clinically judged active hepatitis; Subjects co-infected with hepatitis B and hepatitis C should be excluded (positive HBsAg or HBcAb test and positive HCV antibody test);
- The patient is the investigator, sub-investigator or anyone directly involved in the conduct of the study;
- History or current evidence of any condition or disease that could confound the results of the study, or participation is not in the best interest of the patient in the opinion of the Investigator(s).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Site
Detroit, Michigan, 48202
Research Site
Fairway, Kansas, 66205
Research Site
Greenville, South Carolina, 29605
Research Site
Los Angeles, California, 90033
Research Site
Orange, California, 92868
Research Site
Orange City, Florida, 32763
About this study
Official title: A Phase 1 Clinical Study to Investigate the Safety, Tolerability and to Determine the Maximum Tolerated Dose and Recommended Phase 2 Dose of HLX23 (CD73 Inhibitor) in Patients With Advanced or Metastatic Solid Tumors
The reason for this study is to see if the CD73 inhibitor HLX23 alone is safe and effective in participants with advanced solid cancer.
Read the detailed description
An open-label, dose escalation, first-in-human, phase 1 clinical study to investigate the safety, tolerability and to determine the maximum tolerated dose and recommended phase 2 dose of HLX23 (recombinant anti-CD73 humanized monoclonal antibody) in patients with advanced or metastatic solid tumors
- Conditions
- Advanced Solid Tumor
- Being tested
- HLX23
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX23Drug
Also called CD73 inhibitor
administered IV.
| Study group | Role | What they receive |
|---|---|---|
| HLX23 | Experimental | HLX23 administered IV. Receives: Drug: HLX23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Limiting Toxicity
DLT
Measured: Up to 21 Days
maximum tolerated dose of HLX23
MTD
Measured: Up to 21 Days
Recommended phase 2 dose of HLX23
RP2D
Measured: Up to 21 Days
Secondary outcomes (5)
Pharmacokinetics(PK)
To measure the serum concentration of HLX23
Measured: cycle 1 (one week is a cycle) to day 30 after the last dose
Pharmacodynamic(PD)
Percentage of CD73 receptor occupancy on circulating
Measured: cycle 1, cycle 2, cycle 3 (one week is a cycle) to day 30 after the last dose
Immunogenicity
Incidence of anti-HLX23 antibody (ADA) positive results
Measured: cycle 1, cycle 2, cycle 4, cycle 6 to day 30 after the last dose
Overall Response Rate (ORR)
Percentage of Participants with Complete Response (CR) or Partial Response (PR)
Measured: Baseline through Disease Progression or Death (Estimated at up to 2 Years)
Disease Control Rate (DCR)
Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease
Measured: Baseline through Measured Progressive Disease (Estimated at 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.
- First posted15 Mar 2021
- Study start18 Jul 2022
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Why it stopped: The Early Termination is the result of the sponsor's need to reevaluate the study design and to make needed vendor realignments.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797468
- Sponsor's protocol ID
- HLX23-001
- Status last verified
- Jan 2023
- First submitted
- 4 Mar 2021
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Investigate the Safety, Tolerability and to Determine the Maximum Tolerated Dose and Recommended Phase 2 Dose of HLX23 (CD73 Inhibitor) in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04797468
- Acronym / sponsor ID
- HLX23-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Early Termination is the result of the sponsor's need to reevaluate the study design and to make needed vendor realignments.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 15 Mar 2021 (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.
The reason for this study is to see if the CD73 inhibitor HLX23 alone is safe and effective in participants with advanced solid cancer.
Detailed description
An open-label, dose escalation, first-in-human, phase 1 clinical study to investigate the safety, tolerability and to determine the maximum tolerated dose and recommended phase 2 dose of HLX23 (recombinant anti-CD73 humanized monoclonal antibody) in patients with advanced or metastatic solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLX23 | Experimental | Drug: HLX23HLX23 administered IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Volunteer to participate, fully understand the study and have signed the ICF, willing and have the capacity to comply with and complete all trial procedures;
- Aged ≥ 18 years when signing the ICF;
- Patients with advanced or metastatic solid tumors confirmed by histologically or cytologically, who have failed standard treatment, or who do not have standard treatment regimens, or who are not suitable for standard treatment;
- Patients with at least one evaluable lesion assessed as per RECIST1.1 criteria;
- Patients must be able to supply adequate tumor tissue for biomarker (CD73 and CD68 ) analyses;
Key exclusion criteria (11 listed)
- Patients who still have ≥ grade 2 toxicities from prior therapies;
- Patients who have history of allergic reaction to monoclonal antibodies;
- Concurrent unstable or uncontrolled medical conditions;
- Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix (patients with previous history of malignancy but without evidence of disease for ≥ 3 years can participate in the study);
- History of prior treatment with anti-CD73 antibodies,including patients treated with adenosine receptor antagonists, CD39 or CD73 inhibitors ;
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 |
|---|---|---|
| HLX23Also: CD73 inhibitoradministered IV. | Drug | HLX23 |
Primary outcome
Number of Participants with Dose Limiting Toxicity
Time frame: Up to 21 Days
DLT
maximum tolerated dose of HLX23
Time frame: Up to 21 Days
MTD
Recommended phase 2 dose of HLX23
Time frame: Up to 21 Days
RP2D
5 secondary outcomes
Pharmacokinetics(PK)
Time frame: cycle 1 (one week is a cycle) to day 30 after the last dose
Pharmacodynamic(PD)
Time frame: cycle 1, cycle 2, cycle 3 (one week is a cycle) to day 30 after the last dose
Immunogenicity
Time frame: cycle 1, cycle 2, cycle 4, cycle 6 to day 30 after the last dose
Overall Response Rate (ORR)
Time frame: Baseline through Disease Progression or Death (Estimated at up to 2 Years)
Disease Control Rate (DCR)
Time frame: Baseline through Measured Progressive Disease (Estimated at up to 2 Years)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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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.
6 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 HLX23 in people with Advanced Solid Tumor, run by Shanghai Henlius Biotech at 6 sites in United States.
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 14 inclusion and 11 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 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
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?
Number of Participants with Dose Limiting Toxicity (time frame: Up to 21 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 17 Jan 2023.