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Not yet recruiting NCT07623369

A First-in-Human Study of HH160 in Patients With Advanced Solid Tumors

Phase I Interventional Solid Tumor Non-small Cell Lung Cancer Hepatocellular Carcinoma Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HH160.
Who it may be relevant to
Registry conditions: Solid Tumor, Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Colorectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 in Patients With Advanced Solid Tumors

Overview

This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.

Detailed description

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD), and preliminary antitumor activity of HH160 alone or in combination with antitumor agents in participants with advanced or solid tumors, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), colorectal cancer (CRC), gastroesophageal adenocarcinoma (GEA), head and neck squamous cell carcinoma, renal cell carcinoma (RCC), endometrial carcinoma, cervical cancer, ovarian cancer, small cell lung cancer, triple-negative breast cancer, urothelial carcinoma, and additional tumor types based on emerging clinical data.

Interventions

  • Drug HH160
    Administered by intravenous infusion every 3 weeks (Q3W)

Primary outcome measures

  • Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: From first dose of study drug to 30 days after last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months]
  • Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of HH160 [Time frame: From first dose through the end of Cycle 1 (approximately 1 month)]
Secondary outcome measures (10)
  • Objective Response Rate (ORR) [Time frame: Up to 2 years]
  • Disease Control Rate (DCR) [Time frame: Up to 2 years]
  • Duration of Response (DOR) [Time frame: Up to 2 years]
  • Progression-free Survival (PFS) [Time frame: Up to 2 years]
  • Time to Response (TTR) [Time frame: Up to 2 years]
  • Maximum Observed Plasma Concentration (Cmax) of HH160 [Time frame: Up to 4 months]
  • Elimination Half Time (T1/2) of HH160 [Time frame: Up to 4 months]
  • Time to Maximum Observed Plasma Concentration (Tmax) [Time frame: Up to 4 months]
  • Observed Clearance of HH160 [Time frame: Up to 4 months]
  • Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast) [Time frame: Up to 4 months]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 to 75 years with signed informed consent.
  • Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.
  • At least 1 measurable lesion per RECIST v1.1.
  • Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.
  • Adequate organ function based on protocol-specified laboratory criteria.

Exclusion criteria

  • Active leptomeningeal disease or uncontrolled/untreated brain metastases.
  • History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.
  • Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.
  • Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage/hemoptysis.

NOTE: Other eligibility criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07623369 · HH160-101 · Himalaya

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗