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HMPL-A830 in Solid Tumors

17. juli 2026 opdateret af: Hutchmed

A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors

This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors*, who are refractory or progressed on/after available standard treatment. The study will be conducted in 2 parts:

Dose Escalation (Part A, Phase I), approximately 57 participants will be enrolled.

Dose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Part A: To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for optimization (RDO) of HMPL-A830 in previously treated participants with solid tumors.

Part B: To characterize the safety, tolerability, and preliminary efficacy of HMPL-A830 at RDO(s) to determine recommended dose(s) for phase 2 (RP2D) or phase 3 (RP3D) in participants with selected solid tumors

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

147

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Kina
      • Beijing, Kina
        • Beijing Cancer Hospital
        • Kontakt:
          • Lin Shen
      • Changsha, Kina
        • Hunan Cancer Hospital
        • Kontakt:
          • Yongchang Zhang
      • Chengdu, Kina
        • West China Hospital of Sichuan University
        • Kontakt:
          • Li Zheng
      • Guangzhou, Kina
        • The Sixth Affiliated Hospital,Sun Yat-sen University
        • Kontakt:
          • Yanhong Deng
      • Jinan, Kina
        • Shandong Cancer Hospital
        • Kontakt:
          • shuqin Ni
      • Nanjing, Kina
        • Jiangsu Province Hospital
        • Kontakt:
          • Xiaofeng Chen
      • Taiyuan, Kina
        • Shanxi Provincial Cancer Hospitial
        • Kontakt:
          • Hongxia Lu

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Understood this study and are able to voluntarily sign the informed consent form (ICF);
  2. Male or Female, Age ≥ 18 years;
  3. Histological confirmed, unresectable, advanced or metastatic solid tumor
  4. Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
  5. Life expectancy ≥ 12 weeks
  6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1

Exclusion Criteria:

  1. Use strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug
  2. Major surgery within 28 days prior to the first dose of study drug
  3. Active infection requiring systemic treatment
  4. History of inflammatory gastrointestinal diseases
  5. Known hypersensitivity to any component of HMPL-A830
  6. Pregnant (positive pregnancy test) or lactating;

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: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part A (Dose Escalation)
Medicin: HMPL-A830

Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6

predefined dose levels

Medicin: HMPL-A830
Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types.
Eksperimentel: Part B (Dose Optimization)
Medicin: HMPL-A830

Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6

predefined dose levels

Medicin: HMPL-A830
Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels. Randomization will be stratified by tumor types.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
DLTs
Tidsramme: Approximately 12 months
Number of Participants With of DLTs
Approximately 12 months
Overview of Treatment-emergent Adverse Events (TEAEs)
Tidsramme: Approximately 12 months
The number of participants with Adverse Events and Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Approximately 12 months
Objective Response Rate (ORR)
Tidsramme: Approximately 24 months
Assessed by investigators according to RECIST 1.1
Approximately 24 months
Recommended doses for phase II or III studies (RP2D or RP3D)
Tidsramme: Approximately 12 months
The RP2D or RP3D will be selected by evaluating all available data from the following criteria under consideration: Determination of MTD achieved during the dose escalation part; Safety data obtained across all different doses tested; Tolerability data; PK data; efficacy data.
Approximately 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progressionsfri overlevelse (PFS)
Tidsramme: Cirka 2 år
Tiden fra den første dosis af undersøgelsesmedicinen til datoen for den første radiografiske PD efter RECIST v1.1 eller død af enhver årsag, alt efter hvad der indtræffer først.
Cirka 2 år
Disease control rate (DCR)
Tidsramme: Approximately 2 years
The DCR by RECIST 1.1
Approximately 2 years
Pharmacokinetic Analysis(Cmax)
Tidsramme: Approximately 2 years
Maximum plasma concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Approximately 2 years
Pharmacokinetic Analysis (Cmin)
Tidsramme: Approximately 2 years
Trough concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Approximately 2 years
Pharmacokinetic Analysis(Tmax)
Tidsramme: Approximately 2 years
Time to reach maximum concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Approximately 2 years
Pharmacokinetic Analysis((AUClast)
Tidsramme: Approximately 2 years
Area under concentration-time curve from time zero to the last measurable concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Approximately 2 years
Pharmacokinetic Analysis((AUCtau)
Tidsramme: Approximately 2 years
Area under concentration-time curve from time zero to the end of the dosing interval for HMPL-A830 (antibody drug conjugate, total antibody and payload)
Approximately 2 years
Incidence of anti-drug antibodies (ADAs) against HMPL-A830
Tidsramme: Approximately 2 years
Number and percentage of patients developing anti-HMPL-A830 antibodies, and semiquantitative titer assessment.
Approximately 2 years

Samarbejdspartnere og efterforskere

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

Sponsor

Hutchmed

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 (Anslået)

15. august 2026

Primær færdiggørelse (Anslået)

26. juni 2028

Studieafslutning (Anslået)

26. november 2028

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

17. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2026-830-GLOB1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

Kliniske forsøg med Solid tumor, voksen

Kliniske forsøg med HMPL-A830

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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