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A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors（G-MAP 101）

29. september 2026 opdateret af: Suzhou Genhouse Bio Co., Ltd.

En multicenter, enkeltarm, open-label fase IA/IB klinisk undersøgelse, der evaluerer sikkerheden, tolerabiliteten, farmakokinetikken, farmakodynamik og foreløbig effektivitet af GH56-kapsler hos personer med MTAP-slettet avancerede faste tumorer

This is a multicenter, single-arm, open-label, dose-escalation, dose-expansion study to evaluate the safety, tolerability, PK/PD, and preliminary anti-tumor activity of GH56 Capsule in subjects with advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy. The clinical trial will be carried out in two parts: phase Ia study (dose escalation study) and phase Ib (dose expansion study).The Part Ib dose expansion study includes adult cohort and adolescent cohort (12-17 years of age).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100730
        • Rekruttering
        • Peking Union Medical College Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Lin Zhao, Doctorate
      • Beijing, Beijing Municipality, Kina, 100021
        • Rekruttering
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Kontakt:
        • Ledende efterforsker:
          • Ning Li, Doctorate
      • Beijing, Beijing Municipality, Kina, 100044
        • Rekruttering
        • Peking University People's Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Lu Xie, Doctorate
      • Beijing, Beijing Municipality, Kina, 100070
        • Aktiv, ikke rekrutterende
        • Beijing Tiantan Hospital,Capital Medical University
    • Fujian
      • Fuzhou, Fujian, Kina, 350014
        • Rekruttering
        • Fujian Cancer Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Yunjian Huang, Doctorate
      • Xiamen, Fujian, Kina, 361003
        • Rekruttering
        • The First Affiliated Hospital of Xiamen University
        • Kontakt:
        • Ledende efterforsker:
          • Jianbo Chen, Doctorate
    • Gansu
      • Lanzhou, Gansu, Kina, 730000
        • Rekruttering
        • Gansu Provincial Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Bo Li, Doctorate
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Rekruttering
        • Sun Yat-sen University Cancer Center
        • Kontakt:
          • Xing Zhang, Doctorate
        • Ledende efterforsker:
          • Xing Zhang, Doctorate
      • Guangzhou, Guangdong, Kina, 510515
        • Rekruttering
        • Nanfang Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Laiyu Liu, Doctorate
    • Guangxi
      • Nanning, Guangxi, Kina, 530200
        • Rekruttering
        • Guangxi Medical University Cancer Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Yongkui Lu, Doctorate
    • Guizhou
      • Guiyang, Guizhou, Kina, 550081
        • Rekruttering
        • The Second People's Hospital of Guiyang
        • Kontakt:
        • Ledende efterforsker:
          • Zhuang Kang, Doctorate
    • Henan
      • Zhengzhou, Henan, Kina, 450008
        • Rekruttering
        • Henan Cancer Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Qiming Wang, Doctorate
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Rekruttering
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Kontakt:
          • Jing Chen, Doctorate
        • Ledende efterforsker:
          • Jing Chen, Doctorate
    • Hunan
      • Changsha, Hunan, Kina, 410008
        • Rekruttering
        • Xiangya Hospital of Central South University
        • Kontakt:
        • Ledende efterforsker:
          • Huaping Yang, Doctorate
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210008
        • Rekruttering
        • Nanjing Drum Tower Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Rutian Li, Doctorate
    • Jilin
      • Changchun, Jilin, Kina, 130033
        • Aktiv, ikke rekrutterende
        • China-Japan Union Hospital of Jilin University
    • Shandong
      • Binzhou, Shandong, Kina, 256603
        • Rekruttering
        • Shandong Medical and Pharmaceutical University Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Fangling Ning, Doctorate
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200233
        • Rekruttering
        • Shanghai Sixth People's Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Haiyan Hu, Doctorate
      • Shanghai, Shanghai Municipality, Kina, 201200
        • Rekruttering
        • Shanghai GoBroad Caner Hospital China Pharmaceutical University
        • Kontakt:
        • Ledende efterforsker:
          • Yayi He, Doctorate
    • Shanxi
      • Taiyuan, Shanxi, Kina, 30009
        • Rekruttering
        • Shanxi Provincial Cancer Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Wei Guo, Doctorate
    • Sichuan
      • Yibin, Sichuan, Kina, 644000
        • Rekruttering
        • The Second People's Hospital of Yibin
        • Kontakt:
        • Ledende efterforsker:
          • Kaijian Lei, Doctorate
    • Uygur Autonomous Region
      • Ürümqi, Uygur Autonomous Region, Kina, 830054
        • Rekruttering
        • The First Teaching Hospital of Xinjiang Medical University
        • Kontakt:
        • Ledende efterforsker:
          • Ji Chen, Doctorate
        • Ledende efterforsker:
          • Shaya Mahati, Doctorate
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310022
        • Rekruttering
        • Zhejiang Cancer Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Zhengbo Song, Doctorate
      • Hangzhou, Zhejiang, Kina, 310009
        • Rekruttering
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Kontakt:
        • Ledende efterforsker:
          • Binghao Li, Doctorate
      • Taizhou, Zhejiang, Kina, 317000
        • Rekruttering
        • Taizhou Hospital of Zhejiang Province
        • Kontakt:
        • Ledende efterforsker:
          • Dongqing Lv, Doctorate

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Willing to participate in the clinical trial, understand and sign the informed consent, and comply with the study visits and procedures.
  2. Male and female patients who are ≥12 years of age at consent .
  3. Histologically or cytologically confirmed advanced and/or metastatic malignancies with progression on / intolerance to standard treatment or lack of effective standard treatment.
  4. Evidence of MTAP loss or homozygous MTAP/CDKN2A deletion in tumor tissue.
  5. At least one measurable lesion as per RECIST v1.1 criteria.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
  7. Survival expectations ≥ 12 weeks.
  8. Adequate organ function
  9. Has a negative serum pregnancy test result at screening and is able to comply with contraceptive-barrier requirements.

Exclusion Criteria:

  1. Subject has not recovered from a prior surgical procedure or has undergone any major surgery within 4 weeks prior to the first dose.
  2. Has received any anti-tumor agents within 28 days without delayed toxicity for the treatment of advanced tumors prior to the first administration of GH56 Capsule
  3. Has symptomatic or active progressive central nervous system (CNS) metastases such as molluscum contagiosum metastases.
  4. Subjects who have difficulty in swallowing and have a history of gastrointestinal surgery or other relevant medical disorders that may interfere with the absorption of GH56.
  5. Subjects had a malignant tumor other than the current tumor within 5 years prior to the first administration of GH56 Capsule, except for localized cancers that have been apparently cured or without disease progression or recurrence for at least 5 consecutive years.
  6. Uncontrolled or significant cardiovascular disease
  7. Subjects with documented positive virology status of hepatitis, as confirmed by Screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests, Human Immunodeficiency Virus (HIV).
  8. Conditions that the investigator considers inappropriate for participation in this clinical trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: GH56 Capsule Group

Dose-escalation cohorts and dose-expansion cohorts receiving varying doses of GH56.
Medicin: GH56 Capsule

GH56 capsule for oral administration at specified doses on scheduled days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
1. Determination of Maximum Tolerated Dose (MTD) , RDEs of GH56.
Tidsramme: Approximately 3 years

MTD is the highest dose of a treatment that does not cause unacceptable side effects.

RDEs stand for Recommended Dose for Expansion.
Approximately 3 years
Characterize the Safety of GH56
Tidsramme: Approximately 3 years

Number of participants with treatment-emergent adverse events and serious AEs.
Approximately 3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR)
Tidsramme: Approximately 3 years

Based on assessment of radiographic imaging per RECIST version 1.1
Approximately 3 years
Disease Control Rate (DCR)
Tidsramme: Approximately 3 years

Based on assessment of radiographic imaging per RECIST version 1.1
Approximately 3 years
Duration of Response (DOR)
Tidsramme: Approximately 3 years

Based on assessment of radiographic imaging per RECIST version 1.1
Approximately 3 years
Progression-Free Survival (PFS)
Tidsramme: Approximately 3 years

Based on assessment of radiographic imaging per RECIST version 1.1
Approximately 3 years
Cmax
Tidsramme: Approximately 3 years

The maximum or "peak" concentration of GH56 observed after administration
Approximately 3 years
Tmax
Tidsramme: Approximately 3 years

The time to peak concentration of GH56
Approximately 3 years
T1/2
Tidsramme: Approximately 3 years

Half-life of GH56
Approximately 3 years
PD of GH56
Tidsramme: Approximately 3 years

Change of sDMA protein expression in tumor tissues
Approximately 3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Suzhou Genhouse Bio Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. marts 2025

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

29. februar 2028

Datoer for studieregistrering

Først indsendt

22. januar 2025

Først indsendt, der opfyldte QC-kriterier

22. januar 2025

Først opslået (Faktiske)

28. januar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • GH56C101

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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