Eine First-in-Human-Studie mit BG-C0979 bei Erwachsenen mit fortgeschrittenen soliden Tumoren
Eine multizentrische, offene, Phase-1a/b-Erstuntersuchung am Menschen zur Untersuchung der Sicherheit, Verträglichkeit, Pharmakokinetik und vorläufigen antitumoralen Aktivität von BG-C0979 bei Patienten mit ausgewählten fortgeschrittenen soliden Tumoren
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
- Name: Study Director
- Telefonnummer: 8778285568
- E-Mail: clinicaltrials@beonemed.com
Studienorte
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New South Wales
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Frenchs Forest, New South Wales, Australien, NSW 2086
- Rekrutierung
- Northern Beaches Hospital
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Liverpool, New South Wales, Australien, NSW 2170
- Rekrutierung
- Liverpool Hospital
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Queensland
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South Brisbane, Queensland, Australien, QLD 4101
- Rekrutierung
- Icon Cancer Centre South Brisbane
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Victoria
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Malvern, Victoria, Australien, VIC 3144
- Rekrutierung
- Cabrini Hospital Malvern
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100021
- Rekrutierung
- Cancer Hospital Chinese Academy of Medical Sciences
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400037
- Rekrutierung
- Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
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Fujian
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Fuzhou, Fujian, China, 350028
- Rekrutierung
- Mengchao Hepatobiliary Hospital of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, China, 510245
- Rekrutierung
- Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
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Hubei
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Yichang, Hubei, China, 443003
- Rekrutierung
- Yichang Central Peoples Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 201321
- Rekrutierung
- Fudan University Shanghai Cancer Centerpudong
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Barcelona, Spanien, 08036
- Rekrutierung
- Hospital Clinic de Barcelona
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Barcelona, Spanien, 08035
- Rekrutierung
- Hospital Universitario Vall Dhebron
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Madrid, Spanien, 28040
- Rekrutierung
- Hospital Universitario Fundacion Jimenez Diaz
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Madrid, Spanien, 28223
- Rekrutierung
- Next Oncology Madrid
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02215-5418
- Rekrutierung
- Dana Farber Cancer Institute
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Missouri
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St Louis, Missouri, Vereinigte Staaten, 63110-1010
- Rekrutierung
- Washington University School of Medicine
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New Jersey
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Hackensack, New Jersey, Vereinigte Staaten, 07601
- Rekrutierung
- John Theurer Cancer Center Hackensack University Medical Center
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Texas
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San Antonio, Texas, Vereinigte Staaten, 78229
- Rekrutierung
- Next Oncology San Antonio
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.
- Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.
- Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have adequate organ function.
Exclusion Criteria:
- Prior treatment with any ADAM9 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Phase 1a: Monotherapy Dose Escalation
Participants will receive increasing doses of BG-C0979 as monotherapy. |
Administered by intravenous infusion. |
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Experimental: Phase 1a: Monotherapy Safety Expansion
Participants will receive BG-C0979 as monotherapy. Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in safety expansion. |
Administered by intravenous infusion. |
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Experimental: Phase 1b, Part A: Monotherapy Dose Optimization and Dose Expansion
Participants will receive BG-C0979 as monotherapy in a dose optimization and dose expansion phase at different dose levels of recommended doses for expansion (RDFEs) identified in Phase 1a. |
Administered by intravenous infusion. |
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Experimental: Phase 1b, Part B: Combination Therapy Expansion
Participants will receive BG-C0979 in combination with tislelizumab in select tumor types. |
Administered by intravenous infusion. Administered by intravenous infusion.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Zeitfenster: Up to approximately 24 months
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Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including dose limiting toxicities (DLTs), AEs meeting protocol-defined adverse event of clinical interest (AECI) criteria, laboratory values, and electrocardiogram results. |
Up to approximately 24 months
|
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Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0979 Monotherapy
Zeitfenster: Up to approximately 10 months
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MTD or MAD, defined as the highest dose for which the estimated toxicity rate is closest to the target toxicity rate of 28%, or the highest dose administered, respectively. |
Up to approximately 10 months
|
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Phase 1a: Recommended Dose(s) for Expansion (RDFE[s])
Zeitfenster: Up to approximately 10 months
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The potential RDFE(s) of BG-C0979 will be determined based on the totality of data including the MTD or MAD, long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available. |
Up to approximately 10 months
|
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Phase 1b: Recommended Phase 2 Dose (RP2D)
Zeitfenster: Up to approximately 24 months
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RP2D of BG-C0979 alone and in combination with tislelizumab will be determined based on safety, PK, preliminary antitumor activity, and other relevant data, as available. |
Up to approximately 24 months
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Phase 1b: Overall Response Rate (ORR)
Zeitfenster: Up to approximately 24 months
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ORR as determined from tumor assessment by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For castration-resistant prostate cancer (CRPC), ORR will be assessed by RECIST v1.1 criteria for soft tissue and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR). |
Up to approximately 24 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Phase 1a: Plasmakonzentration von BG-C0979
Zeitfenster: Bis zu ca. 3 Monaten
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Bis zu ca. 3 Monaten
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Phase 1a: Fläche unter der Konzentrations-Zeit-Kurve (AUC) für BG-C0979
Zeitfenster: Bis zu etwa 3 Monaten
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Bis zu etwa 3 Monaten
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Phase 1a: Maximale beobachtete Konzentration (Cmax) von BG-C0979
Zeitfenster: Bis zu ungefähr 3 Monaten
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Bis zu ungefähr 3 Monaten
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Phase 1a: Zeit bis zur maximalen Konzentration (Tmax) von BG-C0979
Zeitfenster: Bis zu etwa 3 Monaten
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Bis zu etwa 3 Monaten
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Phase 1b: Plasmakonzentration von BG-C0979, allein und in Kombination mit Tislelizumab
Zeitfenster: Bis zu ungefähr 3 Monaten
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Bis zu ungefähr 3 Monaten
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Phase 1a: ORR
Zeitfenster: Up to approximately 24 months
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ORR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, ORR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. ORR is defined as the percentage of participants with best overall response of a complete response (CR) or partial response (PR). |
Up to approximately 24 months
|
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Phase 1a and 1b: Duration of Response (DOR)
Zeitfenster: Up to approximately 24 months
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DOR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DOR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
|
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Phase 1a and 1b: Disease Control Rate (DCR)
Zeitfenster: Up to approximately 24 months
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DCR as determined from tumor assessment by the investigator using RECIST v1.1. For CRPC, DCR will be assessed by RECIST v1.1 criteria for soft tissue and PCWG3 criteria for bone lesions. DCR is defined as the percentage of participants with best overall response of a CR, PR, or stable disease. |
Up to approximately 24 months
|
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Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
Zeitfenster: Up to approximately 24 months
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Number of participants with TEAEs and SAEs, including AECIs, laboratory values, and electrocardiogram results. |
Up to approximately 24 months
|
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Phase 1b: Progression-Free Survival
Zeitfenster: Up to approximately 24 months
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PFS is defined as the time from the date of the first administration of study drug(s) to the date of the first documentation of disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
|
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Phase 1b: Radiographic Progression-Free Survival (rPFS) for Participants with CRPC
Zeitfenster: Up to approximately 24 months
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rPFS is defined as the time from the date of the first administration of study drug(s) to the date of the first objective evidence of radiographic disease progression or death due to any cause, whichever occurs first. |
Up to approximately 24 months
|
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Prostate-Specific Antigen (PSA) Response for Participants with CRPC
Zeitfenster: Up to approximately 24 months
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PSA response is defined as a ≥50% decrease in PSA level from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later. |
Up to approximately 24 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Study Director, BeOne Medicines
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BG-C0979-101
- 2025-524857-15-00 (Ctis)
- CTR20261327 (Andere Kennung: ChinaDrugTrials)
- 2025 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
IPD-Sharing-Zeitrahmen
See plan description
IPD-Sharing-Zugriffskriterien
See plan description
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- CSR
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