National Cancer Center/Cancer Hospital
Beijing, China
NCT Number: NCT04977167
This is a Phase I, open-label, repeat-dose, non-randomized, multicenter study to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of HG146 administered orally (PO) alone (Part 1) or co-administered (Part 2) with PD-(L)1 inhibitor in subjects with refractory/relapsed solid tumors or Lymphoma. Part 1 consists of a dose escalation phae,Part2 consists of a dose escalation phase and a cohort expansion phase. In Part 1, escalating doses of HG146 will be evaluated as guided by the "3+3" approach. In Part 2A, escalating doses of HG146 in combination with PD-(L)1 inhibitor will be evaluated as guided by the "3+3" approach. In Part 2B, subjects will receive a single dose level of HG146 as identified based on data from Part 2, in combination with PD-(L)1 inhibitor . A total of approximately 96 subjects will be enrolled in this study, approximately 36 for dose escalation cohorts, and approximately 60 in the expansion cohorts.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Key Exclusion Criteria:
HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.
Other names: HG146 capsule
PD-(L)1 Antibody is available as solution for infusion or lyophilized powder for reconstitution to be administered Q3W. It will be administered as an IV infusion for 30 minutes.
Other names: PD-1 antibody
Time frame: Up to 26 Days in Cycle 0 and Cycle 1
Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0)
Time frame: Up to 2 years
Number of participants experiencing Serious Adverse Events (SAEs) and Adverse Events (AE) According to Safety performance.
Time frame: Up to 2 years
Maximum tolerated dose or Recommended Phase II dose of HG146 will be decided according to safety and effective results.
Time frame: Up to 21 Days in Cycle 1
Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0)
Time frame: Up to 2 years
Number of participants experiencing Serious Adverse Events (SAEs) and Adverse Events (AE) According to Safety performance.
Time frame: Up to 2 years
Maximum tolerated dose or Recommended Phase II dose of HG146 will be decided according to safety and effective results.
Time frame: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)
Plasma concentration of HG146 will be measured following single dose and multiple dose administration
Time frame: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)
Plasma concentration of HG146 will be measured following single dose and multiple dose administration
Time frame: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15(Except for cycle 0, each cycle is 21 days)
Plasma concentration of HG146 will be measured following single dose and multiple dose administration
Time frame: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)
Plasma concentration of HG146 will be measured following single dose and multiple dose administration
Time frame: Up to 2 years
ORR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Time frame: Up to 2 years
BOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Time frame: Up to 2 years
DOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Time frame: Up to 2 years
TTR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Time frame: Up to 2 years
PFS will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Time frame: At the end of Cycle 1 Day 15 (each cycle is 21 days)
Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
Time frame: At the end of Cycle 1 Day 15 (each cycle is 21 days)
Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
Time frame: At the end of Cycle 1 Day 15 (each cycle is 21 days)
Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
Time frame: At the end of Cycle 1 Day 15 (each cycle is 21 days)
Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
Time frame: Up to 2 years
ORR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Time frame: Up to 2 years
BOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Time frame: Up to 2 years
DOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Time frame: Up to 2 years
TTR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Time frame: Up to 2 years
PFS will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Time frame: Up to 2 years
OS will be assessed by the investigators
HitGen Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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