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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 oppdatert av: Suzhou Genhouse Bio Co., Ltd.

En multisenter, en-arm, åpen etikettfase IA/IB klinisk studie som evaluerer sikkerhet, tolerabilitet, farmakokinetikk, farmakodynamikk og foreløpig effekt av GH56-kapsler hos personer med MTAP-slettede avanserte faste svulster

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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: GH56 Capsule Group

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Suzhou Genhouse Bio Co., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. mars 2025

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

29. februar 2028

Datoer for studieregistrering

Først innsendt

22. januar 2025

Først innsendt som oppfylte QC-kriteriene

22. januar 2025

Først lagt ut (Faktiske)

28. januar 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • GH56C101

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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