HG146 / HitGen - LARVOL DELTA

A phase I study of HG146: A novel selective HDAC inhibitor, as single-agent in patients with advanced solid tumors and lymphomas [WITHDRAWN] (AACR 2025) - "Abstract is embargoed at this time."

Clinical • Metastases • P1 data • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: HitGen Inc.

New P2 trial • Adenoid Cystic Carcinoma • Head and Neck Cancer • Oncology • Solid Tumor

Clinical Trial of HG146 Administered to Subjects With Advanced Solid Tumors or Lymphoma (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: HitGen Inc. | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

Clinical Trial of HG146 Administered to Subjects With Advanced Solid Tumors or Lymphoma (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: HitGen Inc. | Trial completion date: Dec 2023 ➔ Jun 2024 | Trial primary completion date: Aug 2023 ➔ Dec 2023

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

A Study of HG146 Capsule in Chinese Subjects With Relapsed and Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=3 | Terminated | Sponsor: HitGen Inc. | N=18 ➔ 3 | Trial completion date: Mar 2023 ➔ Jun 2023 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2022 ➔ Sep 2022; Company decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of HG146 Capsule in Chinese Subjects With Relapsed and Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: HitGen Inc. | Trial completion date: Jun 2022 ➔ Mar 2023 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Clinical Trial of HG146 Administered to Subjects With Advanced Solid Tumors or Lymphoma (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: HitGen Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2021 ➔ Mar 2022

Combination therapy • Enrollment open • Trial initiation date • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

A Study of HG146 Capsule in Chinese Subjects With Relapsed and Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: HitGen Inc.; Trial completion date: Jul 2020 ➔ Jun 2022; Trial primary completion date: Dec 2019 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Clinical Trial of HG146 Administered to Subjects With Advanced Solid Tumors or Lymphoma (clinicaltrials.gov) - P1; N=96; Not yet recruiting; Sponsor: HitGen Inc.

New P1 trial • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

HitGen’s HDAC I/IIb inhibitor pockets another trial nod in China (GBI Health) - "Chengdu-based HitGen Inc. (688222.SH) announced clinical trial approval from the National Medical Products Administration for its Category 1 drug HG146 in advanced solid tumors or lymphoma."

Non-US regulatory • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor

A Study of HG146 Capsule in Chinese Subjects With Relapsed and Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: HitGen Inc.; Trial completion date: Dec 2019 ➔ Jul 2020; Trial primary completion date: Jul 2019 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date

A Study of HG146 Capsule in Chinese Subjects With Relapsed and Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: HitGen Ltd; Active, not recruiting ➔ Recruiting; Initiation date: Aug 2018 ➔ Nov 2018

Clinical • Enrollment open • Trial initiation date