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Advanced Solid TumorPhase 1/2NCT06223308

A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors

A Phase 1/2 study testing HB0028 in people with Advanced Solid Tumor and Cervical Cancer, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

It is a phase I/II open label, multicenter study to assess the safety, tolerability, pharmacokinetics, and efficacy of HB0028 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Cervical Cancer
What is being tested?
HB0028
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChina
Study dates
9 Sep 2022to 1 Oct 2024
Phase
Phase 1/2
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

  • Patients must meet all the following criteria to be eligible for participation in this study:
  • Male or female. Age ≥ 18 years.
  • The subject is able to understand and willing to sign the Informed Consent Form(ICF); willing and able to comply with all study procedures.
  • a) dose escalation: Patients with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors (or clinically diagnosed hepatocellular carcinoma) that failed all standard therapies known to provide clinical benefit; [These solid tumors include but not limit to: non-small cell lung cancer, esophageal squamous cell carcinoma, melanoma, head and neck squamous cell carcinomas, hepatocellular carcinoma, gastric or gastroesophageal junction adenocarcinoma, renal cell carcinoma, etc.].
  • dose expansion (Cervical cancer group): Histologically confirmed persistent, recurrent, or metastatic ([International Federation of Gynecology and Obstetrics(FIGO)] stage IVB) cervical cancer that is not eligible for curative surgery and/or definitive concurrent radiotherapy; The pathological type was squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma.; According to the investigator's judgment, it may benefit from the study drug treatment; patients with disease progression after at least one previous systemic therapy (such as systemic chemotherapy).
  • At least one measurable tumor lesion was present according to RECIST 1.1. A baseline imaging assessment could be performed up to 28 days before the first dose.
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  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
  • Life expectancy ≥12 weeks
  • liver function requirements:
  • Total bilirubin (TBIL) ≤ 1.5×ULN
  • Aspartate aminotransferase(AST) and Alanine aminotransferase(ALT) ≤ 2.5×ULN; AST or ALT ≤5×ULN if liver metastases are present;
  • Creatinine (Scr) < 1.5×ULN and Calculated creatinine clearance (CrCL) > 50 mL/ min (Cockroft-Gault Equation);
  • Hematology absolute neutrophil count (ANC) ≥ 1.5×109/L; hemoglobin (HGB) ≥ 90 g/L ；platelets (PLT) ≥ 75×109/L;
  • Coagulation function: International Normalized Ratio(INR)≤ 1.5×ULN; Prothrombin Time(PT)≤ 1.5×ULN; Activated Partial Thromboplastin Time(APTT)≤ 1.5×ULN. No active or clinically significant bleeding within 14 days before the first dose.
  • Recovery to Grade 0-1 from adverse events (AEs) related to prior anticancer therapy except alopecia, < Grade 2 sensory neuropathy, and endocrinopathies controlled with hormone replacement therapy
  • Women of childbearing potential must confirm a negative serum or urine pregnancy test within 3 days prior to the initiation of study treatment; Fertile patients and their partners must agree to use effective contraceptives for the duration of study drug use and for 90 days after the last administration of study treatment.

Who cannot join

  • Exclusion Criteria Patients are excluded from the study if any of the following criteria apply:
  • Have clinically active central nervous system (CNS) metastases. Patients with previously-treated brain or meningeal metastases may participate and be eligible for treatment provided they are stable (>4 weeks) and asymptomatic. Patients with asymptomatic brain metastasis or subjects who are symptomatically stable after treatment and are on < 10 mg/d prednisone or equivalent are eligible.
  • dose expansion (Cervical cancer group): Hydronephrosis, which could not be relieved by clinical treatment
  • 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.
  • History of Grade 3-4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies, (except for grade 3 endocrinopathy that is managed with hormone replacement therapy).
  • Use of systemic corticosteroids in a dose equivalent to >10 mg/day of prednisone or other immunosuppressive agent < 2 weeks prior to screening; the use of topical, intraocular, intraarticular, intranasal, or inhaled corticosteroids and systemic steroids to prevent (e.g., allergy to contrast agents) or treat non-autoimmune condition (e.g., delayed hypersensitivity caused by exposure to allergens) or short course (< 5 days) will be allowed
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  • Cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, or New York Heart Association (NYHA) class III or IV heart failure < 6 months of study entry; uncontrolled arrhythmia < 3 months of study entry; mean ECG QT-interval corrected according to Fridericia's formula (QTcF) > 470 milliseconds (ms) obtained from three ECGs;
  • uncontrolled diabetes, glycosylated hemoglobin HbA1c >8%；
  • Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study entry; palliative radiotherapy to a single area < 2 weeks prior to study screening is permitted. Measurable lesions cannot be previously irradiated unless they have demonstrated growth after radiation therapy (According to RECIST v1.1).
  • Patients who have previously received allogeneic stem cell, Bone marrow or solid organ transplantation.
  • The following infections are present
  • Active infection requiring intravenous treatment within 2 weeks before screening
  • Active Pulmonary tuberculosis
  • Positive results for HIV test
  • Active hepatitis B or C. Patients with asymptomatic hepatitis B virus carriers (HBV DNA titer < 1000 cps/mL or 200 IU/mL) or cured hepatitis C virus(HCV)(negative HCV RNA test) may be enrolled;
  • Major surgery < 4 weeks prior to the first dose; Minor surgery < 2 weeks prior to the first dose
  • History of severe allergic reactions, grade 3-4 allergic reactions to treatment with another monoclonal antibody, or known to be allergic to protein drugs or recombinant proteins or excipients in HB0028 drug formulation;
  • Have received or will receive a live vaccine within 30 days prior to the screening.
  • Patients who have participated in any clinical trial of a drug or medical device within 30 days prior to the first dose
  • Any other serious underlying medical condition (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), or psychiatric, psychological, familial condition or geographical location that, in the judgment of the Investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment.
  • Positive COVID-19 quantitative real time (qRT) polymerase chain reaction (PCR) or rapid screening test during screening;
  • Patients with a history of arterial or deep vein thrombosis within 6 months before enrollment; evidence or history of a bleeding tendency within 2 months before enrollment
  • Severe dyspnea, pulmonary insufficiency or the need for continuous supportive oxygen therapy
  • The surgical site, the wound site, the mucous membrane severely ulcerated, or the fracture did not heal completely
  • Conditions that may cause bleeding or perforation of the digestive tract (such as duodenal ulcer, intestinal obstruction, Crohn's disease, Ulcerative colitis, large gastrectomy and small bowel resection, etc.); Patients with a history of intestinal perforation and fistula, who were not cured after surgical treatment; Esophageal and gastric varices
  • Immunomodulatory therapy was administered within 2 weeks before enrollment (including but not limited to cyclosporine and tacrolimus)
  • Have history of interstitial lung disease or non-infectious pneumonitis, except from radiotherapy (the enrollment of subjects needs to be considered after discussion with MM);
  • Other conditions which would make it inappropriate for the patient to participate as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

Yuan Tang, Bachelor contact

021-51320053 ext. 6617

yuan.tang@huaota.com

Kexin Hou, Master contact

021-51320053 ext. 6033

kexin.hou@huaota.com

China1 site, 1 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Jing Wang, MD/PHD, 0731-88651900, wangjing0081@126.com

    Yan Tang, MD/PHD, 0731-88651900, tangyan6049@hnca.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of HB0028 in Patients With Advanced Solid Tumors

It is a phase I/II open label, multicenter study to assess the safety, tolerability, pharmacokinetics, and efficacy of HB0028 in patients with advanced solid tumors.

Read the detailed description

This is a phase I/II, multicenter, open-label, first-in-human study in patients with advanced solid tumors. During the phase I study, the safety and tolerability of HB0028 will be evaluated in patients with advanced solid tumors. In the phase II study, the safety and efficacy of HB0028 at the RP2D will be evaluated in cohorts of patients with specific solid tumors.

Being tested
HB0028
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • HB0028Drug

    Also called Anti-PD-L1 and TGF-β bifunctional fusion protein

    Patients will be assigned to dose regimens in the order of enrollment, and they will receive their assigned fixed dose of HB0028 via intravenous infusion. HB0028 IV every 3 weeks (q3w).

Study groups in NCT06223308
Study groupRoleWhat they receive
HB0028ExperimentalHB0028 IV every 3 weeks (q3w)
Receives: Drug: HB0028

What is being measured

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

  1. Safety and tolerability

    Number of participants with a Dose Limiting Toxicity(DLT)[Time Frame:During the first days]DLTs will be assessed during the first 21 days of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria,and assessed as having a suspected or definite relationship to study drug.

    Measured: Up to 12 Months

  2. Maximun Tolerated Dose(MTD)

    MTD or Optimal Biological Dose(OBD) and/or RP2D.

    Measured: Up to 24 Months

Secondary outcomes (4)

  1. AUC

    AUC Area Under concentration-time Curve (AUC)

    Measured: Up to 24 Months

  2. Cmax

    Maximum serum concentration(Cmax)

    Measured: Up to 24 Months

  3. Tmax

    Half-life time of maximum concentration

    Measured: Up to 24 Months

  4. ORR

    Overall response rate(ORR) as measured by RECIST v1.1.

    Measured: Up to 24 Months

Timeline

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

  1. First posted25 Jan 2024
  2. Study start9 Sep 2022
  3. Primary completion1 May 2024 (estimated)
  4. Study completion1 Oct 2024 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
A single-subject cohort will be enrolled at the protocol starting dose of HB0028 every 3 weeks (Q3W). Dose escalation will proceed to the next main dose level according to the 3+3 dose-escalation procedure until the MTD/OBD is reached. Phase II of the study will be initiated at the Sponsor's discretion at the dose level and treatment schedule which was established as the recommended Phase 2 dose (RP2D) in the dose-escalation phase.
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06223308
Sponsor's protocol ID
HB0028-01
Status last verified
Jan 2024
First submitted
24 Dec 2023
Last updated
25 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HB0028 in people with Advanced Solid Tumor and Cervical Cancer, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 1 site 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 16 inclusion and 28 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 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

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?

Results are not available in the source record.

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

Contact Yuan Tang, Bachelor (021-51320053 ext. 6617, yuan.tang@huaota.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: Up to 12 Months). The study lists 2 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 NCT06223308.

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 25 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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