ZX-101A / Zenshine Pharma - LARVOL DELTA

A Study to Evaluate Activity, Safety and Tolerability of ZX-101A in Relapsed/Refractory Hematological Malignancies (clinicaltrials.gov) - P1/2 | N=40 | Completed | Sponsor: Nanjing Zenshine Pharmaceuticals | Recruiting ➔ Completed | N=70 ➔ 40

Enrollment change • Trial completion • Chronic Lymphocytic Leukemia • Cutaneous T-cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

A Phase 1/2a Study of a PI3Kδγ dual inhibitor ZX-101A in patients with advanced solid tumors (AACR 2022) - P1/2 | "Part 2 dose expansion will evaluate ZX-101A activity in up to three disease-specific cohorts. Inclusion of combination therapy is planned after obtaining the initial clinical assessment of ZX-101A on its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients."

Clinical • P1/2 data • Hematological Malignancies • Oncology • Solid Tumor • PIK3CD • PIK3CG

Dose-Escalation and Dose-Expansion Study of ZX-101A in Patients With Relapsed/Resistant or Refractory Advanced Hematologic Malignancies (clinicaltrials.gov) - P1/2 | N=6 | Terminated | Sponsor: Hangzhou Zenshine Pharmaceuticals Co., Ltd. | N=66 ➔ 6 | Trial completion date: Jan 2023 ➔ Jul 2022 | Recruiting ➔ Terminated; Study terminated early due to business decision.

Enrollment change • Trial completion date • Trial termination • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

A Study to Evaluate Activity, Safety and Tolerability of ZX-101A in Relapsed/Refractory Hematological Malignancies (clinicaltrials.gov) - P1/2 | N=70 | Recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P1/2 trial • Chronic Lymphocytic Leukemia • Cutaneous T-cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

A Study to Evaluate the Activity, Safety and Tolerability of ZX-101A in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=76 | Not yet recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

Monotherapy • New P1/2 trial • Oncology • Solid Tumor

[VIRTUAL] A phase 1/2a, dose-escalation and dose-expansion study of ZX-101A in patients with relapsed/resistant or refractory advanced hematologic malignancies (AACR 2021) - P1/2 | "ZX-101A is a next-generation PI3Kδ/γ inhibitor, without the purine motif in the first generation marketed drug duvelisib. Part 2 dose expansion will evaluate ZX-101A activity in up to three disease-specific cohorts (CLL/SLL, indolent NHL, and based on emerging data from Part 1, Peripheral T-cell lymphoma may be included). Inclusion of a cohort of combination therapy is planned."

Clinical • P1/2 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CD4

[VIRTUAL] A next-generation PI3Kδ/γ inhibitor, ZX-101A inhibiting solid tumor growth by enhancing anti-tumor immunity (AACR 2021) - "Its absorption, distribution, metabolism, and excretion (ADME) and safety profile, through a series of preclinical in vitro and in vivo studies, supported the ZX-101A clinical development. These results suggested ZX-101A as a potential immunotherapeutic agent to appropriate solid tumor types."

IO biomarker • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma • GLI2

Dose-Escalation and Dose-Expansion Study of ZX-101A in Patients With Relapsed/Resistant or Refractory Advanced Hematologic Malignancies (clinicaltrials.gov) - P1/2; N=66; Recruiting; Sponsor: Hangzhou Zenshine Pharmaceuticals Co., Ltd.; Not yet recruiting ➔ Recruiting; Initiation date: Sep 2020 ➔ Jan 2021

Clinical • Enrollment open • Trial initiation date • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Dose-Escalation and Dose-Expansion Study of ZX-101A in Patients With Relapsed/Resistant or Refractory Advanced Hematologic Malignancies (clinicaltrials.gov) - P1/2; N=66; Not yet recruiting; Sponsor: Hangzhou Zenshine Pharmaceuticals Co., Ltd.

Clinical • New P1/2 trial • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma