A Phase I Study of HEC-921 Injection as Monotherapy and in Combination with Other AntineoplasticTherapy in Patients with Advanced Malignant Solid Tumors
Trial participants aged ≥18 years at the time of signing the informed consent form, either male or female;
Monotherapy dose escalation and dose expansion phases: Patients with advanced malignant solid tumors who have failed or are intolerant to standard therapy, or for whom no standard therapy exists, and whose tumor tissue is LY6G6D+. During the monotherapy dose escalation phase in the low-dose cohorts , there is no restriction on LY6G6D expression in participants' tumor tissue.
Combination Therapy Phase: Histologically confirmed unresectable advanced colon adenocarcinoma or rectal adenocarcinoma, with no prior systemic therapy, deemed by the investigator suitable for receiving CAPOX combined with bevacizumab as first-line treatment for advanced disease; tumor tissue LY6G6D+ .
Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
Received anti-tumor therapies such as chemotherapy or immunotherapy, or other investigational drugs within 3 weeks prior to the first dose; or received oral fluoropyrimidines, small-molecule targeted drugs, or traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose;
Received radiotherapy (palliative radiotherapy for local bone/brain lesions is permitted if completed within 2 weeks prior to the first dose), major surgical procedures (not fully recovered from surgery or injury), or any live or attenuated live vaccines within 4 weeks prior to the first dose; or planned to receive live vaccines after enrollment;
Patients who received systemic treatment with corticosteroids (prednisone >10 mg/day or equivalent) for more than 1 week or other immunosuppressants within 2 weeks prior to the first dose. Inhaled or topical corticosteroids, or systemic prednisone ≤10 mg/day or equivalent doses of similar drugs, are permitted;
Presence of active central nervous system metastases. Screening is permitted if the patient previously received radiotherapy or surgery, imaging within 4 weeks prior to the first dose indicates stable brain metastases without progression or new neurological symptoms, and corticosteroid therapy was discontinued at least 2 weeks prior to the first dose. Patients with leptomeningeal metastases or brainstem metastases are excluded regardless of treatment status;
Sequential
HEC-921
DrugPatients will receive specific dose of HEC-921 via intravenous infusion.
HEC-921
DrugAdministered via intravenous infusion on Day 1 at the corresponding dose
Oxaliplatin
Drug130 mg/m², administered via intravenous infusion on Day 1
Capecitabine
Drug1000 mg/m² per dose, orally twice daily on Days 1-14
Bevacizumab
Drug7.5 mg/kg, administered via intravenous infusion on Day 1
Dose-Limiting Toxicity (DLT)
Proportion of participants with dose limiting toxicities during DLT observation window, to identify monotherapy and combination derive maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
The severity of adverse events (AEs) will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0.
Objective Response Rate (ORR)
The proportion of trial participants achieving complete response (CR) and partial response (PR) by the investigator based on RECIST 1.1 criteria.
Disease Control Rate (DCR)
The proportion of trial participants achieving CR, PR, or stable disease (SD) (≥6 weeks) by the investigator based on RECIST 1.1 criteria.
Duration of Response
Time from the first occurrence of CR or PR to the first occurrence of progressive disease (PD) or death (whichever occurs first). DoR applies only to trial participants achieving CR or PR by the investigator based on RECIST 1.1 criteria.
Progression-Free Survival ( PFS)
The time from the first dose administration to the first documented PD according to RECIST v1.1 criteria or death from any cause (whichever occurs first) by the investigator based on RECIST 1.1 criteria.
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