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Clinical Trial of HG146 Administered to Subjects With Advanced Solid Tumors or Lymphoma

16 settembre 2026 aggiornato da: HitGen Inc.

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 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

24

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Beijing, Cina
        • National Cancer Center/Cancer Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Part 1:HG146 Monotherapy, Dose-escalation Cohort

Subjects will receive HG146 PO at every two days intervals (qod) for 14 consecutive days,7 days off, 21 days/ cycle. Escalating doses of HG146 will be evaluated using 3+3 approach.

HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.

Altri nomi:
  • HG146 capsule
Sperimentale: Part 2A:HG146 + PD-(L)1 antibody, Dose escalation Cohort

Subjects will receive HG146 PO at every two days intervals (qod) for 14 consecutive days,7 days off, along with PD-(L)1 antibody IV once every 3 weeks (Q3W),21 days/ cycle.

Escalating doses of HG146 in combination with PD-(L)1 antibody will be evaluated.

HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.

Altri nomi:
  • 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.

Altri nomi:
  • Anticorpo PD-1
Sperimentale: Part 2B-1:HG146 combination Expansion Cohort 1

Subjects who have not been treated with PD-(L)1 antibody,will receive HG146 po for 14 consecutive days,7 days off, in combination with PD-(L)1 antibody IV Q3W.

HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.

Altri nomi:
  • 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.

Altri nomi:
  • Anticorpo PD-1
Sperimentale: Part 2B-2:HG146 combination Expansion Cohort 2

Subjects who have progressed on PD-(L)1 antibody, will receive HG146 po for 14 consecutive days,7 days off, in combination with PD-(L)1 antibody IV Q3W.

HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.

Altri nomi:
  • 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.

Altri nomi:
  • Anticorpo PD-1

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part I:Dose-Limiting Toxicities (DLTs)
Lasso di tempo: 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)

Up to 26 Days in Cycle 0 and Cycle 1
Part I:Serious Adverse Events (SAEs) and Adverse Events (AE)
Lasso di tempo: Up to 2 years

Number of participants experiencing Serious Adverse Events (SAEs) and Adverse Events (AE) According to Safety performance.

Up to 2 years
Part I:Maximum tolerated dose or Recommended Phase Ib dose (RP2D) of HG146
Lasso di tempo: Up to 2 years

Maximum tolerated dose or Recommended Phase II dose of HG146 will be decided according to safety and effective results.

Up to 2 years
Part 2A: Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)
Lasso di tempo: 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)

Up to 21 Days in Cycle 1
Part 2A: Serious Adverse Events (SAEs) and Adverse Events (AE)
Lasso di tempo: Up to 2 years

Number of participants experiencing Serious Adverse Events (SAEs) and Adverse Events (AE) According to Safety performance.

Up to 2 years
Part 2A:Maximum tolerated dose or Recommended Phase II dose (RP2D) of HG146 in combination with PD-(L)1 antibody
Lasso di tempo: Up to 2 years

Maximum tolerated dose or Recommended Phase II dose of HG146 will be decided according to safety and effective results.

Up to 2 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part 1:Area under the concentration versus time curve (AUC) of HG146
Lasso di tempo: 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

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)
Part 1:Peak plasma concentration (Cmax) of HG146
Lasso di tempo: 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

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)
Part 1:Time of Cmax (Tmax) of HG146
Lasso di tempo: 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

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)
Part 1:Apparent terminal half-life (T1/2) of HG146
Lasso di tempo: 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

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)
Part1: objective response rate (ORR)
Lasso di tempo: Up to 2 years

ORR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

Up to 2 years
Part1: Best overall response (BOR)
Lasso di tempo: Up to 2 years

BOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

Up to 2 years
Part1: Duration of response (DOR)
Lasso di tempo: Up to 2 years

DOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

Up to 2 years
Part 1:Time-to-response (TTR)
Lasso di tempo: Up to 2 years

TTR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

Up to 2 years
Part 1:Progression-Free Survival (PFS)
Lasso di tempo: Up to 2 years

PFS will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

Up to 2 years
Part 2:Area under the concentration versus time curve (AUC) of HG146
Lasso di tempo: 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

At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part 2:maximum observed plasma concentration (Cmax) of HG146
Lasso di tempo: 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

At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part 2:time of maximum observed plasma concentration (Tmax) of HG146
Lasso di tempo: 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

At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part 2:apparent terminal half-life (T1/2) of HG146
Lasso di tempo: 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

At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part2: objective response rate (ORR)
Lasso di tempo: Up to 2 years

ORR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

Up to 2 years
Part2: Best overall response (BOR)
Lasso di tempo: Up to 2 years

BOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

Up to 2 years
Part2: Duration of response (DOR)
Lasso di tempo: Up to 2 years

DOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

Up to 2 years
Part 2:Time-to-response (TTR)
Lasso di tempo: Up to 2 years

TTR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

Up to 2 years
Part 2:Progression-Free Survival (PFS)
Lasso di tempo: Up to 2 years

PFS will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)

Up to 2 years
Overall survival (OS)
Lasso di tempo: Up to 2 years

OS will be assessed by the investigators

Up to 2 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Yuankai Shi, National Cancer Center/Cancer Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 settembre 2021

Completamento primario (Effettivo)

13 giugno 2024

Completamento dello studio (Effettivo)

22 dicembre 2024

Date di iscrizione allo studio

Primo inviato

12 luglio 2021

Primo inviato che soddisfa i criteri di controllo qualità

23 luglio 2021

Primo Inserito (Effettivo)

26 luglio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • HG146CN102

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .