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.
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. The study will also identify the recommended phase 1 dose (RP2D) of HH160 monotherapy and/or in combination with other chemotherapy regimens.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
299
Administered by intravenous infusion on Day 1 of each 21-day (Q3W) cycle or 14-day (Q2W) cycle.
Calvary Mater Newcastle
Waratah, New South Wales, Australia
RECRUITINGTasman Health Care
Southport, Queensland, Australia
RECRUITINGShandong Tumour Hospital Dongyuan Unit
Jinan, Shandong, China
RECRUITINGPhase 1a: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria.
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
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of HH160
The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively.
Time frame: From first dose through the end of Cycle 1 (approximately 1 month)
Phase 1b: Recommended Phase 2 Dose (RP2D) of HH160
RP2D is defined as the dose level selected based on the overall assessment of safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy
Time frame: From first dose through completion of Phase 1b dose optimization (up to 2 years)
Phase 1b: Overall Response Rate (ORR)
Defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) assessed by the investigator.
Time frame: Up to 2 years
Phase 1a: Objective Response Rate (ORR)
Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as determined by investigator assessment using RECIST v1.1.
Time frame: Up to 2 years
Disease Control Rate (DCR)
Defined as the percentage of participants who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by investigator assessment using RECIST v1.1.
Time frame: Up to 2 years
Duration of Response (DOR)
Defined as the time from the date that a response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first as determined by investigator assessment using RECIST v1.1.
Time frame: Up to 2 years
Progression-free Survival (PFS)
PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first as determined by investigator assessment using RECIST v1.1.
Time frame: Up to 2 years
Phase 1a: Time to Response (TTR)
TTR is defined as the time from start of treatment to the first date that response criteria (CR or PR) were met, as determined by investigator assessment using RECIST v1.1.
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
Phase 1b: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and AEs meeting protocol-defined adverse event of clinical interests (AECIs)..
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 2 years
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