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

12 augusti 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Ia-Part A
Participants with advanced solid tumors will receive GW01-200 tablets orally at ascending dose levels.
Läkemedel: GW01-200
GW01-200 tablets will be administered orally.
Experimentell: Ia-Part B
Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets orally at ascending dose levels.
Läkemedel: GW01-200
GW01-200 tablets will be administered orally.
Experimentell: Ib-Part C
Participants with advanced solid tumors will receive GW01-200 tablets at the specified dose.
Läkemedel: GW01-200
GW01-200 tablets will be administered orally.
Experimentell: Ib-Part D
Participants with relapsed/refractory hematological malignancies will receive GW01-200 tablets at the specified dose.
Läkemedel: GW01-200
GW01-200 tablets will be administered orally.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of participants with adverse events (AEs) and serious AEs (SAEs)
Tidsram: 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
Tidsram: 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.
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum concentration (Cmax)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: Up to approximately 2 years
ORR assessed by investigator.
Up to approximately 2 years
Duration of response (DoR)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Groovy Medicine (Hangzhou) Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 juli 2026

Primärt slutförande (Beräknad)

1 januari 2029

Avslutad studie (Beräknad)

1 juni 2029

Studieregistreringsdatum

Först inskickad

27 maj 2026

Först inskickad som uppfyllde QC-kriterierna

1 juni 2026

Första postat (Faktisk)

5 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • GW01-200-01

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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