Solid Tumor, AdultPhase 1NCT05060263
A Study of of HOT1030 in Patients With Advanced Solid Tumors
A Phase 1 study testing HOT-1030 in people with Solid Tumor, Adult, run by Huabo Biopharm Co., Ltd. at 1 site in China.
Trial summary
A Phase 1, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HOT-1030 in Patients with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- HOT-1030
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2021to 27 Aug 2024
- Phase
- Phase 1
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
- Male or female from 18 to 75 yrs (include 18 yrs and 75 yrs).
- 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.
- Patients with histologically or cytologically confirmed advanced malignant solid tumor who have received or been intolerant of all standard therapies thought to confer clinical benefit.
- Measurable disease on imaging base on RECIST v1.1 for solid tumors;
- Stop anticancer therapy for more than 5 half-lives or 4 weeks (whichever is shorter) prior to study entry;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
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- Adequate organ function, as indicated by the laboratory values.
- Female patients of childbearing potential must have a negative serum pregnancy test at screening; Male patients and the female patients of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the Screening Visit through 90 days after the last dose of study treatment is received.
- Life expectancy >3 months.
Who cannot join
- Received any anti-CD137 antibodies.
- Active primary CNS tumor or metastatic CNS tumor (expect the patients who had received the treatment and stopped the treatment for more than 4 weeks before first dose), active epilepsy, Spinal cord compression or Cancerous meningitis.
- Active autoimmune disease or history of autoimmune disease requiring systemic therapy < 2 years prior to screening except hypothyroidism, vitiligo, Grave's disease, Hashimoto's disease, or Type I diabetes. Patients with childhood asthma or atopy that has not been active in the 2 years prior to study screening are eligible.
- Require systematic anti-infective therapy a week before first dose because of active infection.
- Taken the surgical operations not related to the research 4 weeks before first dose
- Used of systemic corticosteroids (a dose equivalent > 10 mg/day of prednisone or )or other immunosuppressive agents, excepted:
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- Patients are allowed to have topical use or inhaled glucocorticoid.
- Patients are allowed to have a less than seven-day glucocorticoid treatment preventing or treat non-autoimmune allergic diseases.
- The toxicity of previous anti-tumor therapy has not recovered (defined as not recovering to grade 0 or 1, except for alopecia) or has not fully recovered from previous surgery.
- During the 6 months prior to screening, the patient had a history of major cardiovascular and cerebrovascular events, such as myocardial infarction, coronary angioplasty or bypass surgery, heart valve repair, unstable arrhythmias, unstable angina, transient ischemic attack, or cerebrovascular accidents.
- New York Heart Association (NYHA) grade III or IV congestive heart failure.
- Patients with uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg at the time of screening) who had been on a stable dose of antihypertensive drugs for at least 4 weeks at the time of screening).
- Active hepatitis B (hepatitis B virus titer >103 copies /ml or 200IU/ml); Hepatitis C virus infection (HCV-RNA above the detection limit); Prophylaxis antiviral therapy other than interferon is allowed. In patients with advanced liver cancer (HCC), hepatitis B virus titer >104 copies /ml or 2000IU/ml should be excluded.
- A history of known congenital and acquired immunodeficiency, including positive HIV antibody tests.
- Patients with a known history of severe allergic reactions to macromolecular protein formulations/monoclonal antibodies or to any investigational drug component (CTCAE V5.0 grade greater than 3).
- Participated in clinical trials of other drugs within 4 weeks before the first administration.
- Pregnant or lactating women or women at risk of pregnancy have a positive pregnancy test before the first medication.
- Other investigators consider that the patient has any clinical or laboratory abnormality that makes him unsuitable for participation in this clinical study.
- prior history of a clear neurological or psychiatric disorder, including epilepsy or dementia.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Huaota Biopharmaceutical Co., Ltd.
Shanghai, Shanghai Municipality
About this study
Official title: A Phase 1, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HOT1030 in Patients With Advanced Solid Tumors
A Phase 1, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HOT-1030 in Patients with Advanced Solid Tumors
Read the detailed description
This study is an open-label, Phase 1, study to evaluate the safety, tolerability, PK, and PD profiles of HOT-1030 as a monotherapy to assess the maximum tolerated dose (MTD) in subjects with advanced solid tumors.
- Conditions
- Solid Tumor, Adult
- Being tested
- HOT-1030
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOT-1030Drug
Also called no other interventions
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection. Receives: Drug: HOT-1030 |
| Cohort 2 | Experimental | HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection. Receives: Drug: HOT-1030 |
| Cohort 3 | Experimental | HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection. Receives: Drug: HOT-1030 |
| Cohort 4 | Experimental | HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection. Receives: Drug: HOT-1030 |
| Cohort 5 | Experimental | HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection. Receives: Drug: HOT-1030 |
| Cohort 6 | Experimental | HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection. Receives: Drug: HOT-1030 |
| Cohort 7 | Experimental | HOT-1030, every 21 days by intravenous administration. HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection. Receives: Drug: HOT-1030 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as measured by incidence of AEs (Adverse Events)
Incidence and severity of AEs, Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Measured: through study completion， an average of 1 year
Secondary outcomes (3)
Area Under Curve (AUC) of HOT-1030
Area under the concentration-time curve of HOT-1030 in plasma over the time interval from 0 extrapolated to infinity
Measured: 42 days
Maximum Serum Concentration (Cmax) of HOT-1030
Maximum Serum Concentration (Cmax) in plasma
Measured: 42 days
Antitumor Activity of HOT-1030 in Patients With advanced Solid Tumors
Response is defined as a Complete Response + Partial Response and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: through study completion， an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start12 Mar 2021
- Primary completion23 Nov 2023
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- dose-escalation study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huabo Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Han Baohui, Doctor, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060263
- Sponsor's protocol ID
- HOT-1030-1
- Status last verified
- Aug 2024
- First submitted
- 26 Mar 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh R, Kim YH, Lee SJ, Eom HS, Choi BK. 4-1BB immunotherapy: advances and hurdles. Exp Mol Med. 2024 Feb;56(1):32-39. doi: 10.1038/s12276-023-01136-4. Epub 2024 Jan 4.
PubMed 38172595