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Studie av säkerhet och tolerabilitet för BCA101 monoterapi och i kombinationsterapi hos patienter med EGFR-drivna avancerade solida tumörer

2 oktober 2026 uppdaterad av: Bicara Therapeutics

Först i människa, Fas 1/1b, öppen, multicenterstudie av bifunktionellt EGFR/TGFβ-fusionsprotein BCA101 monoterapi och i kombinationsterapi hos patienter med EGFR-drivna avancerade solida tumörer

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

473

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

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

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

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

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: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: BCA101 Monotherapy

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

EGFR/TGFβ fusion monoclonal antibody

Andra namn:
  • Ficerafusp alfa
Experimentell: BCA101 + pembrolizumab

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

EGFR/TGFβ fusion monoclonal antibody

Andra namn:
  • Ficerafusp alfa
Läkemedel: Pembrolizumab

anti-PD-1

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Safety of BCA101 alone and BCA101 in combination with pembrolizumab: Incidence and severity of AEs and SAEs
Tidsram: 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
Tidsram: 24 months

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

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Objective Response Rate
Tidsram: 24 months

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

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

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

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

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

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

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

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

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

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

Incidence and titer of anti-drug-antibodies
24 months

Samarbetspartners och utredare

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

Sponsor

Bicara Therapeutics

Samarbetspartners

Merck Sharp & Dohme LLC

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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)

1 juni 2020

Primärt slutförande (Beräknad)

31 oktober 2027

Avslutad studie (Beräknad)

30 mars 2028

Studieregistreringsdatum

Först inskickad

10 juni 2020

Först inskickad som uppfyllde QC-kriterierna

11 juni 2020

Första postat (Faktisk)

12 juni 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • BCA101X1101
  • KEYNOTE-E28 (Annan identifierare: Merck Sharp & Dohme LLC)

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

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