Solid Tumor
Conditions
Brief summary
The goal of this study is to evaluate the safety of HH-101 antibody, administered as monotherapy to participants with advanced solid tumors.
Interventions
DRUGHH-101 (0.3 mg/kg)
Participants received 0.3 mg/kg HH-101 as an intravenous (IV) infusion on day (D)1 and D21 of each 21-day cycle every 3 weeks (Q3W).
DRUGHH-101 (1 mg/kg )
Participants received 1 mg/kg HH-101 as an intravenous (IV) infusion on day (D)1 and D21 of each 21-day cycle every 3 weeks (Q3W).
DRUGHH-101 (3 mg/kg )
Participants received 3 mg/kg HH-101 as an intravenous (IV) infusion on day (D)1 and D21 of each 21-day cycle every 3 weeks (Q3W).
DRUGHH-101 (10 mg/kg)
Participants received 10 mg/kg HH-101 as an intravenous (IV) infusion on day (D)1 and D21 of each 21-day cycle every 3 weeks (Q3W).
Sponsors
Huahui Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Voluntary signing of the written informed consent form; * Histologic or cytologic confirmation of advanced solid tumor; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; * Have an estimated life expectancy ≥3 Months, in the judgement of the investigator; * Must have at least 1 measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Exclusion criteria
* History of other malignancies within 5 years prior to the first dose of study drug, except for malignancies that have been cured after treatment, such as thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the breast. * Receipt of the last systemic anti-tumor therapy within 2 weeks prior to the first dose of study drug, including chemotherapy, radiotherapy, targeted therapy, or traditional Chinese herbal medicine or patent Chinese medicines with anti-tumor activity. Patients who received tumor immune checkpoint inhibitor therapy within 4 weeks prior to the first dose of study drug. * Adverse reactions from previous treatments that have not recovered to CTCAE v5.0 Grade 1 or lower (except for alopecia and neuropathy, which, in the Investigator's judgment, are long-standing and not expected to recover). * Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation. * If female, is pregnant, breastfeeding, or planning to become pregnant. * Known hypersensitivity to HH-101 Injection or any of its components. History of severe hypersensitivity reactions to other therapeutic antibody drugs. Known allergy to multiple substances or history of severe allergic diseases. * Known interstitial lung disease or non-infectious pneumonitis requiring steroid therapy. * Other severe, acute, or chronic medical conditions, psychiatric disorders, or laboratory abnormalities that, in the Investigator's judgment, may increase the risk associated with study participation or may interfere with the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs) per Common Terminology Criteria for Adverse Events v6.0 (CTCAE v5.0) | Baseline through safety follow up completion (Up To 24 Months) | It will be assessed by the frequency, severity and nature of AEs, serious adverse event (SAE), changes in vital signs, physical examination, 12-lead ECG, laboratory tests (haematology, blood chemistry, urinalysis, coagulation Function, Thyroid Function Test and etc.), The severity of AEs will be graded by the NCI CTCAE version 5.0 and the AE terms will be coded by the current version of the Medical Dictionary for Regulatory Activities (MedDRA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration-time curve (AUC) | up to 24 months | — |
| Maximum observed plasma concentration (Cmax). | up to 24 months | — |
| Time to reach Cmax (Tmax). | up to 24 months | — |
| Terminal elimination half-life (t1/2). | up to 24 months | — |
| Objective response rate (ORR) | Baseline through Measured Progressive Disease (Up To 24 Months) | Investigate preliminary antitumor activity of HH-101 as assessed by radiological response per RECIST v1.1. ORR is defined as the proportion of subjects who achieve a Complete Response (CR) or Partial Response (PR) following treatment. |
| Disease control rate (DCR) | Baseline through Measured Progressive Disease (Up To 24 Months) | Investigate preliminary antitumor activity of HH-101 as assessed by radiological response per RECIST v1.1. DCR is defined as the proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) following treatment. |
| Duration of response (DOR) | Baseline through Measured Progressive Disease or death (Up To 24 Months) | Investigate preliminary antitumor activity of HH-101 as assessed by radiological response per RECIST v1.1. DOR is defined as the time from the first documentation of objective response until the first documentation of tumor progression or death from any cause. |
| progression-free survival (PFS) | Baseline through Measured Progressive Disease or death (Up To 24 Months) | Investigate preliminary antitumor activity of HH-101 as assessed by radiological response per RECIST v1.1. PFS is defined as the time from the start of treatment until the first documentation of tumor progression or death from any cause. |
| overall survival (OS) | Baseline through the date of death from any cause (Up to 24 Months) | Investigate preliminary antitumor activity of HH-101 as assessed by radiological response per RECIST v1.1. OS is defined as the time from the start of treatment until death from any cause. |
Countries
China
Outcome results
None listed