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Studie av sikkerhet og tolerabilitet av BCA101 monoterapi og i kombinasjonsterapi hos pasienter med EGFR-drevne avanserte solide svulster

2. oktober 2026 oppdatert av: Bicara Therapeutics

Først-i-menneske, fase 1/1b, åpen, multisenterstudie av bifunksjonelt EGFR/TGFβ fusjonsprotein BCA101 monoterapi og i kombinasjonsterapi hos pasienter med EGFR-drevne avanserte solide svulster

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a Phase 1/1b, open-label study, which consists of dose escalation parts (Part A) followed by expansion cohorts (Part B) for both single agent BCA101 and combination BCA101 plus pembrolizumab.

The study population in dose escalation (Part A) of single agent BCA101 consists of subjects with EGFR-driven advanced solid tumors refractory to standard of care or for whom no standard of care is available. Dose escalation (Part A) of combination BCA101 and pembrolizumab consists of subjects with either Squamous Cell Carcinoma of the Head and Neck (HNSCC) or Squamous Cell Carcinoma of the Anal Canal (SCCAC) whose tumors are refractory to standard of care or for whom no standard of care is available.

Once the maximum tolerated dose (MTD) / recommended dose (RD) of single agent BCA101 is determined, the study will continue with expansion cohorts (Part B) with select tumor types. Expansion cohorts for single agent BCA101 will include cutaneous squamous cell carcinoma. Planned expansion cohorts for the combination of BCA101 and pembrolizumab include: 1) HNSCC and 2) SCCAC.

Studietype

Intervensjonell

Registrering (Antatt)

473

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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Rekruttering
        • Chris O'Brien Lifehouse
        • Hovedetterforsker:
          • Jenny Lee, MBBS, FRACP
        • Ta kontakt med:
          • Telefonnummer: (02) 8514 0000
      • Waratah, New South Wales, Australia, 2298
        • Rekruttering
        • Calvary Mater Newcastle
        • Ta kontakt med:
          • Telefonnummer: +61 2 40143590
        • Hovedetterforsker:
          • Fiona Day
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Rekruttering
        • Austin Hospital
        • Ta kontakt med:
          • Telefonnummer: +61394965000
        • Hovedetterforsker:
          • Alesha Thai, MBBS, FRACP, PhD
      • Melbourne, Victoria, Australia, 3000
        • Rekruttering
        • Peter MacCallum Cancer Centre
        • Ta kontakt med:
          • Telefonnummer: +61 3 8559 5000
        • Hovedetterforsker:
          • Danny Rischin, MD
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Rekruttering
        • Princess Margaret Cancer Centre
        • Ta kontakt med:
          • Telefonnummer: 18007110500
        • Hovedetterforsker:
          • Phillippe Bedard, MD
    • Quebec
      • Montreal, Quebec, Canada
        • Rekruttering
        • Centre hospitalier de l'Université de Montréal (CHUM)
        • Ta kontakt med:
          • Telefonnummer: (514) 890-8000
        • Hovedetterforsker:
          • Antoine Desilets, MD
  • Forente stater
    • California
      • La Jolla, California, Forente stater, 92093
        • Rekruttering
        • Moores Cancer Center UC San Diego Health
        • Hovedetterforsker:
          • Assuntina Sacco, MD
        • Ta kontakt med:
      • Los Angeles, California, Forente stater, 90095
        • Rekruttering
        • UCLA
        • Hovedetterforsker:
          • Deborah Wong, MD
        • Ta kontakt med:
          • UCLA Clinical Trials Office
          • Telefonnummer: 310-794-8783
      • Los Angeles, California, Forente stater, 90033
        • Rekruttering
        • Keck School of Medicine of USC
        • Hovedetterforsker:
          • Gino In, MD
        • Ta kontakt med:
          • Clinical Trials Office
          • Telefonnummer: 323-442-1900
      • Sacramento, California, Forente stater, 95817
        • Rekruttering
        • University of California, Davis Comprehensive Cancer Center
        • Hovedetterforsker:
          • Andrew Birkeland, MD
        • Ta kontakt med:
          • Clinical Trials Office
          • Telefonnummer: 916-703-9184
    • Florida
      • Tampa, Florida, Forente stater, 33612
        • Rekruttering
        • H. Lee Moffitt Cancer Center and Research Institute, Inc
        • Hovedetterforsker:
          • Christine Chung, MD
        • Ta kontakt med:
          • Clinical Trials Office
          • Telefonnummer: 813-945-3563
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Rekruttering
        • Dana Farber/Partners Cancer Care Inc
        • Ta kontakt med:
          • DFCI Clinical Trials Hotline
          • Telefonnummer: 877-338-7425
        • Hovedetterforsker:
          • Michael Dennis, MD
    • New York
      • New York, New York, Forente stater, 10032
        • Rekruttering
        • Columbia University Herbert Irving Comprehensive Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Catherine Shu, MD
      • New York, New York, Forente stater, 10017
        • Rekruttering
        • Memorial Sloan Kettering
        • Ta kontakt med:
          • Telefonnummer: 646-608-3759
        • Hovedetterforsker:
          • Eric Sherman, MD
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28204
        • Rekruttering
        • Levine Cancer Institute
        • Hovedetterforsker:
          • Daniel Carrizosa, MD
        • Ta kontakt med:
          • Telefonnummer: 980-442-3213
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Rekruttering
        • Cleveland Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Tamara Sussman, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15232
        • Rekruttering
        • UPMC Hillman Cancer Center
        • Hovedetterforsker:
          • Dan Zanberg, MD
        • Ta kontakt med:
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02903
        • Rekruttering
        • Rhode Island Hospital
        • Hovedetterforsker:
          • Ariel Birnbaum, MD
        • Ta kontakt med:
          • Brown Health Clinical Trials Office
          • Telefonnummer: 401-444-5113
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Rekruttering
        • Medical University of South Carolina, Hollings Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • John Kaczmar, MD
        • Ta kontakt med:
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Rekruttering
        • Vanderbilt University Medical Center
        • Hovedetterforsker:
          • Jennifer Choe, MD, PhD
        • Ta kontakt med:
          • Vanderbilt Clinical Research Center
          • Telefonnummer: 615-322-2312
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • MD Anderson Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Van Morris, MD

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patient must have measurable disease amendable to biopsy and be willing to undergo both a pre-treatment and on-treatment biopsy, as well as provide archival tumor if available from the primary tumor (a paraffin embedded tumor tissue block sufficient to obtain at least 10 sections of 4 to 5 micrometer thickness).
  • Patient must have a performance status of ≤1 on the Eastern Cooperative Oncology Group Performance Scale.
  • Patients must have evaluable or measurable disease (computed tomography [CT]/magnetic resonance imaging [MRI] scans performed within 21 days before the screening visit are acceptable) demonstrating measurable disease, i.e., at least 1 unidimensional measurable lesion as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST).
  • Tumor eligibility:

PART B (Cohort expansion):

  1. Single agent BCA101 - patients with the following tumor type will be eligible:

    • Expansion Cohort 1: Cutaneous Squamous Cell Carcinoma (CSCC) - i. patients must have received (or been intolerant to or ineligible for) prior anti-PD-1 therapy in the metastatic or locally advanced setting.

    ii. No prior history of treatment with anti-EGFR antibodies in the unresectable/metastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed).

  2. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:

    • Expansion Cohort 2: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) equal to or greater than 1, as determined by an CLIA-approved laboratory test. Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology).

    i. Patients must have no prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed >6 months prior if given as part of multimodal treatment for locally advanced disease) or prior history of immune checkpoint inhibitors with the exception of neoadjuvant therapy (>6 months prior to study drug initiation). No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease).

    ii. Patients must provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.

    iii. Patients must have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer

    • Expansion Cohort 3: Squamous Carcinoma of the Anal Canal (SCAC), locally advanced/unresectable or metastatic.

      i. Patients must have received (or been intolerant to or ineligible for) at least 1 prior line of chemotherapy and received no more than 2 prior lines of systemic treatments for treatment of unresectable and/or metastatic disease. No prior history of immune checkpoint inhibitors.

    • Expansion Cohort 5: Squamous Non-Small Cell Lung Cancer (SqNSCLC) i. Patients must have a histologically or cytologically confirmed diagnosis of stage IV (AJCC 8th edition) squamous NSCLC. Patients with mixed histology (e.g., adenosquamous) are not allowed.

    ii. Patients must have progressed on one prior systemic therapy in the metastatic setting.

    iii. No prior history of treatment with anti-EGFR antibodies in the metastatic setting.

    • Expansion Cohort 6: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx.

  3. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab • Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.

Exclusion Criteria:

  • For Part A: Exposure to anti-EGFR antibodies within 4 weeks of the first dose of study drug.
  • Prior treatment with any anti-TGFβ therapy.
  • Prior history of Grade ≥ 2 intolerance or hypersensitivity reaction to cetuximab or other anti-EGFR therapy or other murine proteins or prior discontinuation of therapy in the setting of toxicity related to treatment.
  • Pregnant or breastfeeding women.
  • Any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose of study drug, with the exception of topical, intranasal, intrabronchial, or ocular steroids.
  • Known history of a hematologic malignancy (or solid tumor other than the ones indicated for this study), unless the patient has undergone potentially curative therapy with no evidence of that disease for 2 years. Does not include tumors with a negligible risk of metastasis or death (e.g. adequately treated basal or squamous cell carcinoma, stage 1 prostate cancer, or carcinoma in situ of the cervix or carcinoma in situ of the breast). Subjects enrolling in the CSCC cohort may have chronic lymphocytic leukemia as long as the patient is not on active treatment.
  • Known cases of human immunodeficiency virus (HIV) are excluded if patients have a CD4+ T-cell (CD4+) count <250 cells/uL. To ensure that effective antiretroviral therapy (ART) is tolerated and that toxicities are not confused with investigational drug toxicities, trial participants should be on established ART for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
  • Patients with chronic HBV infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment
  • Patients with a known history of hepatitis C who have not completed curative antiviral treatment or have a HCV viral load above the limit of quantification

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: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: BCA101 Monotherapy

Route: IV Infusion Frequency: QW Current Dose: 1500mg
Legemiddel: BCA101

EGFR/TGFβ fusion monoclonal antibody

Andre navn:
  • Ficerafusp Alfa
Eksperimentell: BCA101 + pembrolizumab

Route: IV Infusion Frequency: Q3W Dose: 200mg
Legemiddel: BCA101

EGFR/TGFβ fusion monoclonal antibody

Andre navn:
  • Ficerafusp Alfa
Legemiddel: Pembrolizumab

anti-PD-1

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs
Tidsramme: 24 months

Incidence and severity of AEs and SAEs
24 months
Tolerability of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs
Tidsramme: 24 months

Incidence and severity of AEs and SAEs
24 months
Incidence of Dose Limiting Toxicities (DLTs)
Tidsramme: 21 days

Incidence of DLTs during the first cycle of treatment with BCA101 monotherapy or the combination of BCA101 and pembrolizumab.
21 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective Response Rate
Tidsramme: 24 months

Determine objective response rate in each part of the study, per RECIST v1.1 and iRECIST
24 months
Clinical Benefit Rate
Tidsramme: 24 months

Determine clinical benefit rate in each part of the study, per RECIST v1.1 and iRECIST
24 months
Progression free survival
Tidsramme: 24 months

Determine PFS in each part of the study, per RECIST v1.1 and iRECIST
24 months
Duration of Response
Tidsramme: 24 months

Determine duration of response in each part of the study, per RECIST v1.1 and iRECIST
24 months
Overall Survival
Tidsramme: 24 months

Determine survival rates in each part of the study.
24 months
AUC of BCA101 and pembrolizumab
Tidsramme: 24 months

AUC
24 months
Cmax of BCA101 and pembrolizumab
Tidsramme: 24 months

Cmax
24 months
Tmax of BCA101 and pembrolizumab
Tidsramme: 24 months

Tmax
24 months
Concentration vs time profile of BCA101 and pembrolizumab
Tidsramme: 24 months

Ctrough
24 months
Half-life of BCA101 and pembrolizumab
Tidsramme: 24 months

Half-life
24 months
Immunogenicity of BCA101 and pembrolizumab
Tidsramme: 24 months

Incidence and titer of anti-drug-antibodies
24 months

Samarbeidspartnere og etterforskere

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

Sponsor

Bicara Therapeutics

Samarbeidspartnere

Merck Sharp & Dohme LLC

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

1. juni 2020

Primær fullføring (Antatt)

31. oktober 2027

Studiet fullført (Antatt)

30. mars 2028

Datoer for studieregistrering

Først innsendt

10. juni 2020

Først innsendt som oppfylte QC-kriteriene

11. juni 2020

Først lagt ut (Faktiske)

12. juni 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BCA101X1101
  • KEYNOTE-E28 (Annen identifikator: Merck Sharp & Dohme LLC)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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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