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

NCT07554196 | Completed Phase 1

• 1 other identifier: HH101-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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)

Study Arms (4)

HH-101 Dose escalation (cohort 1)

EXPERIMENTAL

Drug: HH-101 (0.3 mg/kg)

HH-101 Dose escalation (cohort 2)

EXPERIMENTAL

Drug: HH-101 (1 mg/kg )

HH-101 Dose escalation (cohort 3)

EXPERIMENTAL

Drug: HH-101 (3 mg/kg )

HH-101 Dose escalation (cohort 4)

EXPERIMENTAL

Drug: HH-101 (10 mg/kg)

Interventions

HH-101 (0.3 mg/kg) DRUG

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).

HH-101 Dose escalation (cohort 1)

HH-101 (1 mg/kg ) DRUG

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).

HH-101 Dose escalation (cohort 2)

HH-101 (3 mg/kg ) DRUG

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).

HH-101 Dose escalation (cohort 3)

HH-101 (10 mg/kg) DRUG

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).

HH-101 Dose escalation (cohort 4)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huahui Health: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 28, 2026
• Study Start: January 19, 2022
• Primary Completion: August 9, 2023
• Study Completion: March 21, 2024
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)