Evaluating HG146 for patients with advanced solid tumors or lymphoma

A Phase I Open Label Study of HG146 Alone /in Combination with PD-(L)1 Inhibitor Administered with and Without Anticancer Agents in Participants with Advanced Solid Tumors or Lymphoma

This study is testing a new treatment called HG146 for people with advanced solid tumors or lymphoma to see if it is safe and effective, both on its own and when combined with another medication.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: HitGen Inc. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT04977167 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial is designed to assess the safety, tolerability, and preliminary clinical activity of HG146 in patients with advanced solid tumors or lymphoma. The study consists of two parts: Part 1 involves a dose escalation phase where escalating doses of HG146 will be administered alone, while Part 2 evaluates HG146 in combination with a PD-(L)1 inhibitor. The trial will enroll approximately 96 subjects, with a focus on those who have progressed on or are intolerant to existing therapies. The study employs a '3+3' dose escalation approach to determine the recommended dose for further investigation.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic solid tumors or lymphoma who have not responded to or are intolerant of existing therapies.

Not a fit: Patients who have not been diagnosed with advanced solid tumors or lymphoma, or those who have not progressed on previous therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients with advanced solid tumors or lymphoma who have limited therapeutic alternatives.

How similar studies have performed: While this approach is being explored in this specific context, similar studies involving PD-(L)1 inhibitors have shown promise in treating various cancers.

Eligibility criteria

Key Inclusion Criteria:

1 Subject must be \>=18 years of age at the time of signing the informed consent.

2- Ia/Ib dose escalation phase（Part1 and Part 2A）：Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.

* Ib dose expansion phase（Part 2）:

  1. Cohort 1,Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established, have not been treated with PD-(L)1 antibody； 2）Cohort 2,Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established, have progressed on PD-(L)1 antibody； 3 Measurable disease per RECIST version 1.1 or Lugano 2014（If applicable）. 4 Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1. 5 Has adequate organ function. 6 Signed informed consent form (ICF) and able to comply with study requirements.

Key Exclusion Criteria:

1. Received prior therapies targeting HDAC.
2. Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment.
3. History of intolerant of anti-PD-(L)1 toxicity（Ib）.
4. A condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of enrollment.
5. Major surgery or major injury \<=28 days before the first dose of study treatment,or anticipated major surgery during the study.
6. Received other anticaner therapies within 4 weeks prior to first dose of study treatment or 5 half life period of anticancer drug .
7. Active infection requiring systemic treatment.
8. Prior allogeneic bone marrow transplantation or other solid organ transplantation ( Ib)
9. Active autoimmune disease or disease of impaired immune system(Ib).
10. History of Adrenal insufficiency.(Ib)
11. History orConcurrent condition of other malignant tumors.
12. Recent (within the past 6 months) history of Unstable or serious diseases, such as pancreatitis, severe angina, prolonged QT interval, congestive heart failure, myocardial infarction, pulmonary hypertension, stroke, and severe seizures, etc.
13. History of severe lung disease.
14. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.

Where this trial is running

Beijing

• National Cancer Center/Cancer Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Yuankai Shi — National Cancer Center/Cancer Hospital
• Study coordinator: Jie Shen

Conditions Solid Tumor; Lymphoma