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Study of HB0036 for Advanced Solid Tumors

This study is testing a new drug called HB0036 for people with advanced solid tumors, including a type of lung cancer called non-small cell lung cancer (NSCLC). It's a Phase I/II study, meaning it will first look at the safety and best dose of HB0036, and then see how well it works. You would receive HB0036 through an IV every three weeks. To join, you must be at least 18 years old and have advanced cancer that has not responded to standard treatments. The study aims to understand the safety and side effects of HB0036, and how effective it is. We don't know the current recruitment status for this study.

Study design
This is an open-label, multi-center Phase I/II study, meaning both you and your doctors will know you are receiving HB0036. About 80 people are planned to participate.
What's involved
You will receive HB0036 through an intravenous (IV) infusion every three weeks. The study will monitor your safety and tolerability for up to 12 months, and the maximum tolerated dose for up to 24 months.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability will be monitored for up to 12 months, and the maximum tolerated dose will be assessed for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05417321

A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Shanghai Huaota Biopharmaceutical Co., Ltd.
~80 participants
Updated 2025-01-03 on ClinicalTrials.gov
What's tested:HB0036

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability
Measured over Up to 12 Months
+1 more outcome measured

Conditions

Advanced Solid Tumor
NSCLC

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NCT05417321

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Horizon Oncology

    Lafayette, Indianastudy coordinator listed

    Recruiting

  • Next Oncology

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • Shandong Hospital

    Jinan, Shandong, Chinastudy coordinator listed

    Recruiting

  • Summit Cancer Centers

    Spokane, Washingtonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Yang Yang, MD/PHD · STUDY_DIRECTOR · Shanghai Huaota Biopharmaceutical Co., Ltd.

Who to contact

Jingjing Wang, Master
[email protected]
021-51320053 · ext. 6029
Email the study team

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Eligibility criteria

Inclusion

absolute neutrophil count (ANC) ≥ 1.5×109/L;
AST and ALT ≤ 2.5×ULN; AST or ALT ≤5×ULN if liver metastases are present;
International normalized ratio (INR)or prothrombin time (PT)≤ 1.5×ULN (unless patient on oral anticoagulant with stable dose); ② Activated partial thromboplastin time (APTT)≤ 1.5×ULN; 8. 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 9. 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 10. The subject is able to understand and willing to sign the ICF; willing and able to comply with all study procedures.

What this trial measures

  • Safety and tolerabilityUp to 12 Months

    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.

  • MTDUp to 24 Months

    MTD or OBD and/or RP2D.