This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of GNTbm-38 in adult patients with advanced solid tumors and R/R PTCL.
Female and/or male aged ≥ 18 to ≤ 75 years.
Histologically or cytologically proven advanced solid tumors or R/R PTCL. For solid tumors, patients must have relapsed or refractory disease after failure of all standard therapies. For R/R PTCL, PTCL subtypes as defined by the WHO classification of tumors (Swerdlow 2022) may be included: PTCL, not otherwise specified (PTCL-NOS), anaplastic lymphoma kinase-positive (ALK+) anaplastic large-cell lymphoma (ALCL), ALK-negative (ALK-) ALCL, angioimmunoblastic T-cell lymphoma (AITL), etc., except cutaneous form, leukemic form and extra-nodal natural killer (NK)/T-cell lymphoma, nasal type (ENKL). R/R PTCL patients must have relapsed or have refractory disease after at least one line of systemic therapy. Patients with CD30+ PTCL should have received a CD30-targeted agent when applicable, and patients with ALK+ ALCL should have received an ALK inhibitor.
ECOG performance status of 0 to 2.
Estimated life expectancy of > 3 months.
Underlying physical or psychological medical condition that, in the opinion of the Investigator, would make the patient unlikely to comply with the protocol or complete the study.
Blood or plasma donation or significant blood loss within 30 days prior to the first administration of IP.
Fever (body temperature > 38°C) or symptomatic viral or bacterial infection within 1 week prior to Screening.
Infections requiring parenteral antibiotics within 4 weeks prior to Screening.
Single group
GNTbm-38
DrugPhase 1a is the dose escalation phase to firstly determine the MTD of patients with solid tumor. Once MTD for solid tumor patients has been established, the next lower dose of this MTD will serve as an initial dose to determine the MTD for patients with R/R PTCL. Phase 1b is the dose expansion phase to evaluate the safety, tolerability, and efficacy of GNTbm-38 in R/R PTCL patients.
Phase 1a: The MTD and DLT of GNTbm-38
The primary endpoint of the Phase 1a portion of the study was the incidence and severity of dose-limiting toxicities (DLTs) of GNTbm-38 administered orally once daily during the first cycle of evaluation (each cycle is 28 days). The efficacy assessments will be define by RECIST v1.1.
Phase Ia: To define the safety and tolerability
To evaluate the efficacy of GNTbm-38 via analysis of anti-tumor activity in adult patients with Relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). The efficacy assessments will be define by 2014 Lugano classification.
Phase Ib: To evaluate the efficacy of GNTbm-38 in patients with R/R PTCL.
Phase 1b dose expansion cohort will be initiated following the MTD from Phase Ia to further evaluate the safety and preliminary efficacy of GNTbm-38 in patients with R/R PTCL, response will be defined by the Lugano criteria.
Maximum plasma concentration (Cmax)
To characterize the PK of GNTbm-38
Time to reach maximum concentration (Tmax)
To characterize the PK of GNTbm-38
Area under the plasma concentration-time curve (AUC)
To characterize the PK of GNTbm-38
Trough concentration (Ctrough)
To characterize the PK of GNTbm-38
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