HMPL-453 Tartrate Combined With Chemotherapy or Teriprizumab in Patients With Advanced Solid Tumors
Status:
Not yet recruiting
Trial end date:
2025-08-01
Target enrollment:
Participant gender:
Summary
This is a phase Ib/II clinical study evaluating the safety, tolerability and preliminary
efficacy of HMPL-453 combined with chemotherapy or teriprizumab in patients with advanced
solid tumors. This study includes a dose exploration phase and a dose expansion phase.
The dose exploration phase includes 5 cohort studies (cohorts A, B, C, D, E), and a total of
about 24 to 60 patients with advanced solid tumors were enrolled in this stage (cohorts B and
C enrolled about 3 to 12 cases, others The cohort was enrolled in about 6-12 cases) and
received HMPL-453 combined chemotherapy or teriprizumab treatment to evaluate the
tolerability, safety and PK characteristics of HMPL-453 combined treatment. In the process of
dose exploration, chemotherapeutics and teriprizumab will use a fixed dose, and only the
dose/administration method of HMPL-453 will be adjusted. Each cohort and method of
administration can be expanded to up to 12 patients.
About 60 to 81 patients were enrolled in the dose expansion stage to evaluate the initial
efficacy of HMPL-453 combination therapy. After the RP2D and the mode of administration are
determined in the dose exploration stage, the safety and preliminary effectiveness of
HMPL-453 combination therapy will be further evaluated in patients with advanced solid tumors
accompanied by specific FGFR gene changes.
All patients will receive the corresponding treatment until the disease progresses, the
toxicity is intolerable, the informed consent is withdrawn, or other reasons that need to
stop the study treatment occur (whichever occurs first). The sponsor can decide whether to
further expand the enrollment based on PK, preliminary efficacy and safety data.
During the entire study period, the longest period of gemcitabine and cisplatin was no more
than 24 weeks, and the use time of teriprizumab was no more than 24 months.
In this study, patients were evaluated on tumor imaging according to the Response Evaluation
Criteria in Solid Tumors (RECIST) v1.1. Patients will undergo tumor imaging evaluation every
6 weeks (±7 days) within 48 weeks after the first medication, and every 12 weeks (±7 days)
after 48 weeks, until disease progression occurs. Initiation of new anti-tumor treatment,
withdrawal of informed consent, loss of follow-up, death or termination of the study,
whichever occurs first.
All SAEs need to be collected from the patient signing the pre-screening informed/informed
consent form to before the first medication; after the first medication to 30 days after the
last medication, or before the start of a new anti-tumor treatment (whichever occurs first),
collect all SAEs All adverse events (Adverse Event, AE)/SAE. 30 days after the last
administration or after the start of a new anti-tumor treatment (whichever occurs first),
only SAEs that the investigator judges to be reasonably likely to be related to the study
drug are reported. All AEs will be graded according to the National Cancer Institute Common
Adverse Events Evaluation Criteria (NCI CTCAE) version 5.0.
After the study treatment is terminated and the treatment is completed, patients will undergo
safety follow-up (30 days ± 7 days after the last medication) and survival follow-up (every
12 weeks ± 7 days).