AzTrials
AzTrials

Solid TumorsPhase 1/2NCT06992687

A Study to Evaluate the Safety and Efficacy of HB0052 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing HB0052 Injection in people with Solid Tumors, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

To evaluate the safety and tolerability of HB0052 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
Solid Tumors
What is being tested?
HB0052 Injection
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
1 Sep 2024to 30 Nov 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Male or female, aged ≥ 18 years
  • The subject is able to understand and willing to sign the ICF and is willing and able to comply with all study procedures.
  • Patients with known UGT1A1 genotype determination results or is willing to accept UGT1A1 genotype determination test.
  • For subjects in phase 2 studies, previous tumor biopsy specimens or fresh tumor biopsy specimens is required.
  • Phase I: Patients with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors (or clinically diagnosed hepatocellular carcinoma) that failed (progressed on or are intolerant of) all standard therapies known to provide clinical benefit [These solid tumors include but not limited to: pancreatic, colorectal, ovarian, breast, lung, head and neck, prostate, renal cancer and sarcoma, etc.].
  • Phase II: Patients who have had at least one prior systemic therapy and has progressed, and might benefit from the study drug in the Investigator's judgment, and have the following histological types (The types of tumors and the number of treatment lines may be adjusted based on phase I results and /or SRC discussions):
Show all 18Show fewer
  • a.Pancreatic cancer cohort: i.Histologically or cytologically confirmed unresectable, locally advanced or metastatic pancreatic ductal adenocarcinoma; b.Endometrial carcinoma cohort: i.advanced/unresectable, recurrent, or metastatic endometrial carcinoma, or recurrent, metastatic histologically uterine serous papillary carcinoma (USPC) with measurable disease.
  • c.Gastric and GEJ adenocarcinoma cohort: i.Histologically or cytologically confirmed locally advanced unresectable or metastatic gastric and GEJ adenocarcinoma ii.HER2 low expression and negative for claudin 18.2 d.RCC cohort: i.Pathologically (histologically or cytologically) proven of locally advanced unresectable or metastatic renal cell carcinoma.
  • e.HCC cohort: i.inoperable locally advanced, recurrent, or metastatic HCC ii.Patients with Child-Pugh grade A liver function
  • f.Other histologically confirmed unresectable, locally advanced or metastatic advanced solid tumor cohort(s): Tumor specific type that demonstrated partial response to HB0052 in the dose escalation phase.
  • At least one measurable lesion as per RECIST v. 1.1 defined as non-nodal lesions having at least one dimension with a minimum size of 10 mm in the longest diameter by CT or MRI scan or ≥15 mm in short axis for nodal lesions. Radiographic disease assessment at baseline can be performed up to 28 days prior to the first dose.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
  • Life expectancy ≥12 weeks.
  • Patients with active hepatitis B virus (HBV) without active disease (HBV DNA titer <1000 cps/mL or 200 IU/mL), or who are cured of hepatitis C virus (HCV) with a negative HCV RNA test may be enrolled at the investigator's discretion.
  • Patients with known human immunodeficiency virus (HIV) infection and a cluster of differentiation 4 (CD4) count that is tested or documented to be ≥350 cells/mm3 within 12 months before study screening.
  • Adequate organ function as defined by the following criteria:
  • Women of childbearing potential must confirm a negative serum pregnancy test within 3 days prior to the initiation of study treatment and begin use of an effective birth control directly after testing negative for pregnancy; Fertile patients and their partners must agree to use acceptable contraception for the duration of study drug use and for 120 days after the last administration of study treatment.
  • 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.

Who cannot join

  • Concurrent malignancy < 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma. Patients with prostate cancer that is under active surveillance are eligible.
  • Patients with Gilbert's disease
  • Patients with a history of COPD or other severe respiratory disease in the 6 months before screening
  • Patients with active ≥ grade 2 anorexia, nausea or vomiting.
  • Patients with a history of intestinal obstruction or perforation in the 6 months before screening
  • Patients with grade 3 or higher toxicity due to irinotecan use
Show all 25Show fewer
  • Patients with reduced UGT1A1 activity or who are predisposed to or have a history of chronic diarrhea.
  • Have clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain or meningeal metastases may participate and be eligible for treatment provided they are stable and asymptomatic. Patients with asymptomatic brain or meningeal metastasis or patients who are symptomatically stable after treatment and are on ≤ 10 mg/d prednisone or equivalent are eligible.
  • Cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, or New York Heart Association (NYHA) class III or IV heart failure occurred within 6 months before study admission；Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 450 millisecond (ms) in males and > 470 ms in female; malignant arrhythmia < 3 months of study entry (judged by the Investigator). Has a history of cardiomyopathy or myocarditis. Patients with rate-controlled arrhythmias may be eligible for study entry at discretion of the Investigator.
  • Active autoimmune disease or history of autoimmune disease requiring systemic therapy < 2 years prior to screening. The following exceptions can be included: hypothyroidism, vitiligo, Graves' 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.
  • Patients who have previously received allogeneic stem cell or solid organ transplantation.
  • 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 HB0052 drug formulation.
  • History of Gr3-4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies, (except for Gr3 endocrinopathy that is managed with hormone replacement therapy).
  • Continuous systemic corticosteroids administration in a dose equivalent to 10 mg/day or more of prednisone or prednisone-equivalent or other immunosuppressants for 5 days or more within 2 weeks before screening. The following exceptions are allowed: the use of corticosteroids in a short course (within one week) to administration topical, intraocular, intraarticular, intranasal, or inhaled are allowed.
  • Have received or will receive a live vaccine within 4 weeks prior to the first dose.
  • Any of the following infections
  • Positive COVID-19 qRT-PCR or rapid screening test during screening; can be eligible one week after COVID-19 test becomes negative.
  • Patients with active tuberculosis (TB) who are receiving anti-TB treatment or who received anti-TB treatment within 1 year prior to screening.
  • Active bacterial infection unresolved less than 2 weeks prior to first dose of study drug
  • Prior treatment with agents targeting CD73 or A2AR.
  • Anticancer therapy < 5 half-lives or 4 weeks (whichever is shorter) prior to study entry;; CYP3A4 inhibitors and/or inducers therapy or OATP inhibitors therapy < 3 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 (RT).
  • Major surgery or chemotherapy/ interventional therapy/radiation therapy/ablation therapy < 4 weeks prior to the first dose and those who have experienced significant trauma or require elective major surgery during the study period (needle biopsy, needle drainage, bronchoscopy or venous cannulation allowed enrolling.)
  • Patients who have participated in any clinical trial of a drug, biologic or medical device within 4 weeks prior to the first dose.
  • Psychiatric, psychological, familial condition or geographical location that, in the judgment of the Investigator, may interfere with the planned staging, treatment and follow-up and affect patient's compliance or place the patient at high risk from treatment.
  • 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. Contact the study team or a site near you to ask about taking part.

China1 site

  • Peking University Cancer Hospital

    Beijing

Other trials in China

About this study

Official title: A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0052 in Patients With Advanced Solid Tumors

To evaluate the safety and tolerability of HB0052 in patients with advanced solid tumors

Read the detailed description

To determine the maximum tolerated dose (MTD) or dose-limiting toxicity（DLT）or optimal biological dose (OBD) and/or the recommended Phase 2 doses (RP2Ds) for HB0052.

Conditions
Solid Tumors
Being tested
HB0052 Injection
Keywords
HB0052

What participants receive

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

  • HB0052 InjectionDrug

    An antibody- drug conjugate (ADC) that targets CD73 with SN38 as the payload

Study groups in NCT06992687
Study groupRoleWhat they receive
HB0052ExperimentalIV every 3 weeks (q3w)
Receives: Drug: HB0052 Injection

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 21 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. MTD

    MTD or OBD and/or RP2D.

    Measured: Up to 24 Months

Secondary outcomes (3)

  1. 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

Timeline

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

  1. First posted28 May 2025
  2. Study start1 Sep 2024
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Nov 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06992687
Sponsor's protocol ID
HB0052-01
Status last verified
Apr 2025
First submitted
23 Apr 2025
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HB0052 Injection in people with Solid Tumors, 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 18 inclusion and 25 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: enrolling by invitation, as of the sponsor's last update on 28 May 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

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 NCT06992687.

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 28 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in