A Phase 1 Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HH-101 in Patients With Advanced Solid Tumors

An Open-Label Phase 1 Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HH-101 as Monotherapy in Patients With Advanced Solid Tumors

The goal of this study is to evaluate the safety of HH-101 antibody, administered as monotherapy to participants with advanced solid tumors.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: HH-101 (0.3 mg/kg); Drug: HH-101 (1 mg/kg ); Drug: HH-101 (3 mg/kg ); Drug: HH-101 (10 mg/kg)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HH-101 Dose escalation (cohort 1)	Drug: HH-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).
Experimental: HH-101 Dose escalation (cohort 2)	Drug: HH-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).
Experimental: HH-101 Dose escalation (cohort 3)	Drug: HH-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).
Experimental: HH-101 Dose escalation (cohort 4)	Drug: HH-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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	Baseline through safety follow up completion (Up To 24 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Baseline through Measured Progressive Disease (Up To 24 Months)
Disease control rate (DCR)	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.	Baseline through Measured Progressive Disease (Up To 24 Months)
Duration of response (DOR)	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.	Baseline through Measured Progressive Disease or death (Up To 24 Months)
progression-free survival (PFS)	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.	Baseline through Measured Progressive Disease or death (Up To 24 Months)
overall survival (OS)	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.	Baseline through the date of death from any cause (Up to 24 Months)

Collaborators and Investigators

• Sponsor: Huahui Health

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): August 9, 2023
• Study Completion (Actual): March 21, 2024

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HH101-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No