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A Phase I Trial of GW01-200 Tablets in Subjects With Advanced Tumors (GW01-200-01)

12 augustus 2026 bijgewerkt door: Groovy Medicine (Hangzhou) Ltd.

A First-in-Human Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GW01-200 Tablets in Subjects With Advanced Tumors

A phase 1, open-label, first-in-human study mainly aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GW01-200 tablets in participants with advanced tumors, including solid tumors and hematological malignancies.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Werving
        • Peking University Cancer Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Zhi-Hao Lu, M.D.
    • Heibei
      • Langfang, Heibei, China, 065000
        • Werving
        • Hebei Cancer Hospital of Chinese Academy of Medical Sciences
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Werving
        • Zhejiang Cancer Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Zheng-Bo Song, M.D.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Documented locally advanced or metastatic solid tumors or advanced hematological malignancies, with disease progression after standard treatment, or intolerant to standard treatment, or no standard treatment is available.
  • Have at least one measurable target lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Minimum life expectancy ≥ 3 months.
  • Adequate organ and marrow function.

Exclusion Criteria:

  • Participants with a known hypersensitivity to the investigational product(s) or any of the excipients of the product(s).
  • History of other primary malignancies, except for those who have been curatively treated and have no known active disease within 5 years prior to the first dose with a very low potential for recurrence, or adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid cancer with no evidence of disease.
  • Presence of primary central nervous system (CNS) tumors or symptomatic brain metastases; prior or current leptomeningeal disease or spinal cord compression.
  • Radiographic evidence of tumor invasion into major blood vessels (tumor completely approaching, surrounding, or invading the lumen of major blood vessels such as the pulmonary artery or superior vena cava) or evidence of tumor thrombus.
  • Received systemic anti-tumor therapy within 28 days prior to the first dose, including chemotherapy, targeted therapy, anti-angiogenic drugs, biological therapy, immunotherapy, radiotherapy, etc., or received traditional Chinese medicine or herbal medicines with clear anti-tumor effects within 1 week prior to the first dose.
  • Treatment with medications that may affect the metabolism of the investigational drug within 14 days prior to the first dose, such as strong CYP3A inhibitors, strong CYP3A inducers, or P-gp inhibitors.
  • Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of the investigational drug.
  • Known to have active infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis.
  • Known history of infection with human immunodeficiency virus (HIV).
  • Active gastrointestinal disease or other condition that will interfere significantly with the swallowing, absorption, distribution, metabolism, or excretion of oral therapy.
  • For female subjects: currently pregnant or lactating.
  • Presence of clinically significant severe ophthalmic examination abnormalities at screening, such as retinitis pigmentosa, maculopathy, active ocular infection, etc., or known history of retinal or optic nerve disorders, such as retinitis pigmentosa, maculopathy, glaucoma, optic neuritis, etc.
  • Participants with a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or a history of melena or hematemesis within 2 months before dosing, or those who may experience visceral hemorrhage as determined by the investigator.
  • Clinically symptomatic moderate to severe ascites or pleural effusion, or presence of uncontrolled or moderate to severe pericardial effusion.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Ia-Part A
Participants with advanced solid tumors will receive GW01-200 tablets orally at ascending dose levels.
Geneesmiddel: GW01-200
GW01-200 tablets will be administered orally.
Experimenteel: Ia-Part B
Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets orally at ascending dose levels.
Geneesmiddel: GW01-200
GW01-200 tablets will be administered orally.
Experimenteel: Ib-Part C
Participants with advanced solid tumors will receive GW01-200 tablets at the specified dose.
Geneesmiddel: GW01-200
GW01-200 tablets will be administered orally.
Experimenteel: Ib-Part D
Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets at the specified dose.
Geneesmiddel: GW01-200
GW01-200 tablets will be administered orally.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants with adverse events (AEs) and serious AEs (SAEs)
Tijdsspanne: Up to approximately 2 years
To assess the safety and tolerability of GW01-200 tablets.
Up to approximately 2 years
Parts A and B: The recommended dose(s) for expansion (RDEs) of GW01-200 tablets
Tijdsspanne: At the end of Cycle 1 (each cycle is 28 days)
Number of participants with dose-limiting toxicities (DLTs)
At the end of Cycle 1 (each cycle is 28 days)
Parts C and D: The preliminary efficacy of GW01-200 tablets at the RDEs dose.
Tijdsspanne: Up to approximately 2 years
Objective response rate (ORR) assessed by investigator.
Up to approximately 2 years
Parts C and D: The recommended Phase II Dose (RP2D) of GW01-200 tablets
Tijdsspanne: Up to approximately 2 years
The RP2D of GW01-200 tablets will be determined based on the data obtained from Parts C and D.
Up to approximately 2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximum concentration (Cmax)
Tijdsspanne: Up to approximately 2 years
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
Up to approximately 2 years
Area under the concentration-time curve (AUC)
Tijdsspanne: Up to approximately 2 years
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
Up to approximately 2 years
Time to maximum concentration (Tmax)
Tijdsspanne: Up to approximately 2 years
To characterise the pharmacokinetics (PK) of GW01-200 when given orally.
Up to approximately 2 years
Elimination half-life (t1/2)
Tijdsspanne: Up to approximately 2 years
To characterise the pharmacokinetics (PK) of GW01-200 when given orally
Up to approximately 2 years
Parts A and B: The preliminary efficacy of GW01-200 tablets in participants with advanced tumors
Tijdsspanne: Up to approximately 2 years
ORR assessed by investigator.
Up to approximately 2 years
Duration of response (DoR)
Tijdsspanne: Up to approximately 2 years
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
Up to approximately 2 years
Disease control rate (DCR)
Tijdsspanne: Up to approximately 2 years
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
Up to approximately 2 years
Progression-free survival (PFS)
Tijdsspanne: Up to approximately 2 years
To assess the preliminary anti-tumour activity of GW01-200 tablets in participants with advanced tumors.
Up to approximately 2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Groovy Medicine (Hangzhou) Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

17 juli 2026

Primaire voltooiing (Geschat)

1 januari 2029

Studie voltooiing (Geschat)

1 juni 2029

Studieregistratiedata

Eerst ingediend

27 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

12 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • GW01-200-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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