ClinicalTrials.gg
Not yet recruitingNCT07552558Updated Nov 3, 2026

Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

A Phase 1/2 interventional study of Hypofractionated Stereotactic Body Radiotherapy (SBRT) and Pembrolizumab in Head and Neck Squamous Cell Carcinoma and HPV-Negative Squamous Cell Carcinoma, sponsored by Washington University School of Medicine. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Washington University School of Medicine · Phase 1/2, Interventional, and Treatment

Updated Nov 3, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study is an open-label phase I/II clinical trial. The study will enroll patients to receive neoadjuvant SBRT plus 1 or 2 doses of neoadjuvant pembrolizumab with concurrent ficerafusp alfa (4 doses) prior to definitive surgical resection for high-risk, locoregionally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). Approximately 6 weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection followed by SOC adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. Adjuvant therapy is not part of this study and therefore is not dictated by study protocol.

02

Conditions studied

  • Head and Neck Squamous Cell Carcinoma
  • HPV-Negative Squamous Cell Carcinoma

Keywords

  • Shortened fractionation radiation
  • Immunotherapy
  • Curative treatment
  • Oral cavity cancer
  • Tongue cancer
  • Gum cancer
  • Jaw cancer
  • Palate cancer
  • Lip Cancer
  • Throat cancer
  • Mouth cancer
  • Voice box cancer
  • Head and neck cancer
  • Oral cancer
  • Laryngeal cancer
  • Mandibular cancer
  • Alveolar ridge cancer
  • Hypopharyngeal cancer
  • Oropharyngeal cancer
  • OPSCC
  • OCC
  • OCSCC
  • HNSCC
  • Squamous cell carcinoma
  • Neoadjuvant therapy
  • Preoperative treatment
  • Stereotactic body radiotherapy
  • Radiation therapy
  • Targeted therapy
  • Keytruda
  • BCA101
  • PD-1 inhibitor
  • EGFR inhibitor
  • Checkpoint inhibitor
  • Locally advance
  • HP-negative
03

In context

Squamous Cell Carcinoma of Head and Neck

2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.

This study's planned enrollment of 45 is close to the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.

Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Newly diagnosed or cytologically confirmed locally advanced, OPC HPV-negative head and neck squamous cell carcinoma (OPSCC) or HNSCC arising from oral cavity, larynx, or hypopharynx.
  • Baseline resectable disease per the judgment of the treating surgical oncologist.
  • Clinical stage III, IVA, or IVB disease as defined using the 8th (2017) edition of the tumor, node, (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):

    • T1-2, N1-3 or
    • T3, any N or
    • T4, any N
  • Documented tumor CPS ≥ 1 (by PD-L1 IHC pharmDx assay), determined locally.
  • Willing to provide blood and newly obtained core or excisional of tumor lesion pre-treatment and at the time of surgery for pathologic and correlative analyses.
  • Age 18 years or older at the time of .
  • (ECOG) performance status of 0 or 1
  • Adequate organ and marrow function as defined below:

    • ≥ 1.5 K/cumm
    • ≥ 100 K/cumm
    • ≥ 9 g/dL (without PRBC transfusion in the prior 7 days)
    • Total serum ≤ 1.5 x IULN (except for subjects with documented diagnosis of Gilbert syndrome). For subjects with a documented diagnosis of Gilbert's syndrome, total bilirubin must be ≤ 3.0 × , provided that direct bilirubin is within normal limits
    • (SGOT)/ALT(SGPT) ≤ 2.5 x IULN
    • (measured or calculated via the Cockcroft-Gault equation or per institutional standards) ≥ 30 mL/min
    • or aPTT ≤ 1.5 x IULN (except for subjects receiving anticoagulant therapy)
  • The effects of pembrolizumab and ficerafusp alfa on the developing human fetus are unknown. For this reason, people of and people able to father a child must agree to use adequate prior to study entry, for the duration of study participation, and for 120 days (women) or 90 days (men) after completion of study treatment.
  • Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion criteria

Exclusion Criteria:

  • Currently receiving any other agents.
  • Prior history of grade ≥ 2 intolerance or reactions to other murine proteins, or the active substances of ficerafusp alfa, pembrolizumab, or any of their .
  • At higher risk of bleeding, including known bleeding diathesis or current active major bleeding, or recent major bleeding episode (within 4 weeks prior to enrollment).
  • Any of the following within 6 months prior to starting study treatment: ST-elevation myocardial infarction, severe/unstable angina, uncontrolled cardiac ventricular arrhythmia, coronary/peripheral artery bypass graft or stent, cerebrovascular accident/stroke less than 6 months prior to enrollment, or congestive heart failure. Subjects with deep vein thrombosis who are hemodynamically stable can enroll if they are on a stable dose of anticoagulants for at least 3 months.
  • Active disease requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, , or drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Active systemic infection requiring either hospitalization or parenteral anti-infective therapy within 2 weeks before first dose of study treatment.
  • Chronic virus (HBV) infection with active disease meeting the criteria for anti-HBV therapy but not on a suppressive antiviral therapy prior to initiation of study treatment. HBV testing not required in the absence of known history of infection. Note: Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. These subjects should remain on antiviral therapy throughout the study treatment period and follow local guidelines for HBV antiviral therapy post completion of study treatment.
  • Known history of virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible provided they completed curative antiviral therapy at least 4 weeks prior to initiation of study treatment. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
  • Known history of (HIV) (HIV 1/2 antibodies) with viral load >0 or CD4\<350. HIV testing is not required in the absence of known history of infection.
  • Receipt of any organ transplantation, including and allogeneic stem cell transplantation, except for transplants that do not require immunosuppression.
  • Known to be diagnosed and/or treated for any other additional within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer defined as follows: Stage T1c or T2a with a Gleason score ≤ 6 and prostatic-specific antigen \< 10 ng/mL either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study entry. Other exceptions may be considered with the PI's consultation. The time requirement for no malignancy for 2 years does not apply to the cancer for which a subject is enrolled in the study.
  • Any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids. Corticosteroid use as premedication for allergic reactions (e.g., intravenous contrast), or as a prophylactic management of AEs related to the therapies specified in the protocol is allowed. The use of physiologic doses of corticosteroids may be approved after consultation with the principle-Investigator.
  • Use of a live or within 4 weeks prior to Screening. Note: Administration of killed, recombinant, or inactivated vaccines is allowed.
  • Pregnant or breastfeeding. People of must have a negative pregnancy test at screening and within 7 days of first dose of study treatment.
Terms in these criteria, in plain language(28)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Phase 1 Dose Level 1: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa

    Treatment during the Phase 1 Level 1 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1, 3, and 5), 2 doses of neoadjuvant pembrolizumab at 200 mg (given on D1 and D22), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.

    Radiation: Hypofractionated Stereotactic Body Radiotherapy (SBRT) · Biological: Pembrolizumab · Drug: Ficerafusp alfa

  • Experimental
    Phase 1 Dose Level -1: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa

    Treatment during the Phase 1 Level -1 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1, 3, and 5), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.

    Radiation: Hypofractionated Stereotactic Body Radiotherapy (SBRT) · Biological: Pembrolizumab · Drug: Ficerafusp alfa

  • Experimental
    Phase 1 Dose Level -2: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa

    Treatment during the Phase 1 Level -2 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Days 1 and 4), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.

    Radiation: Hypofractionated Stereotactic Body Radiotherapy (SBRT) · Biological: Pembrolizumab · Drug: Ficerafusp alfa

  • Experimental
    Phase 1 Dose Level -3: Dose De-Escalation Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa

    Treatment during the Phase 1 Level -3 consists of Stereotactic Body Radiotherapy (SBRT) at 8 Gy x 3 fractions over one week (given on Day 1), 1 dose of neoadjuvant pembrolizumab at 200 mg (given on D1), and 4 weekly doses of ficerafusp alfa at 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.

    Radiation: Hypofractionated Stereotactic Body Radiotherapy (SBRT) · Biological: Pembrolizumab · Drug: Ficerafusp alfa

  • Experimental
    Phase 2: Maximum Tolerable Dose (MTD) Neoadjuvant SBRT and pembrolizumab plus ficerafusp alfa

    Treatment consists of SBRT beginning on D1 at the dose and number of fractions established in phase I, neoadjuvant pembrolizumab 200 mg at the number of doses established in phase I, and 4 weekly doses of ficerafusp alfa 750 mg (given on D1, D8, D15, and D22). Six weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection, or biopsy for patients who do not undergo resection, followed by standard of care (SOC) adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines.

    Radiation: Hypofractionated Stereotactic Body Radiotherapy (SBRT) · Biological: Pembrolizumab · Drug: Ficerafusp alfa

Interventions

  • RadiationHypofractionated Stereotactic Body Radiotherapy (SBRT)

    1-3 fractions given over 1 week as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II

  • BiologicalPembrolizumab

    200 mg intravenously (IV) given on Day 1 or Days 1 and 22 as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II.

    Also known as: Keytruda

  • 750mg intravenously (IV) on Days 1, 8, 15, and 22.

    Also known as: BCA101

06

What researchers measure

Primary outcomes

  1. Phase I only: Maximum tolerated dose (MTD) of SBRT in combination with pembrolizumab plus ficerafusp alfa

    The maximum tolerated dose (MTD) is defined as the highest dose level at which 0 or 1 patients of a cohort experience dose-limiting toxicity during the dose limiting toxicity (DLT) window. DLTs are defined in the protocol.

    Time frame: From start of treatment until date of surgery (total estimated time of 7 weeks)

  2. Phase II only: Rate of pathologic complete response (pCR)

    Response will be defined according to the systematic pTR system. pTR is defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor). pCR is defined as follows: 100% of sample characterized by tumor necrosis, keratinous debris, and/or giant cells/histiocytes

    Time frame: At the time of surgery (estimated to be week 7)

Secondary outcomes

  1. Phase II only: Number and types of Adverse Events (AEs)

    As defined by CTCAE v5.0.

    Time frame: From start of treatment through 5 years after completion of treatment (estimated to be 5 years and 2 months)

  2. Phase II only: Pathological response rate (PRR)

    PRR is categorized as pCR, mPR, and others (pTR-0, pTR-1, pTR-2). Simon's two-stage optimal design will be used for a rate of pCR in phase II. Response will be defined according to the systematic pTR system. pTR is defined as the presence of tumor cell necrosis and keratinous debris with giant cell/histiocytic reaction, quantified as a percentage of the overall tumor bed (area pathologic response/area pathologic response plus viable tumor). pTR is defined as follows: pTR-0: \< 10% of sample characterized by tumor necrosis, keratinous debris, and/or giant cells/histiocytes, pTR-1: 10-49%, pTR-2: 50-89%, pTR-3: 90-99% (also referred to as mPR), and pTR-4: 100% (also referred to as pCR).

    Time frame: At time of surgery (estimated to be week 7)

  3. Phase II only: Event-free survival (EFS)

    EFS is defined as the time from the first date of treatment to the date of disease progression or death, whichever occurs first.

    Time frame: From start of treatment through 5 years after completion of treatment (estimated to be 5 years and 2 months)

  4. Phase II only: Rate of clinical to pathologic down staging (and extent of surgical plan modifications, if any)

    Time frame: At time of surgery (estimated to be week 7)

  5. Phase II only: Overall survival (OS)

    OS is defined as the time from the first date of treatment to the date of death. Alive patients are censored at the last follow-up otherwise.

    Time frame: From start of treatment through 5 years after completion of treatment (estimated to be 5 years and 2 months)

07

Study locations

1 site
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    • Sana Karam, MD, PhD · Contactsanadkaram@wustl.edu · 314-362-9700
    • Sidharth Puram, MD, PhD · Contactsidpuram@wustl.edu · 314-362-9700
    • Sana Karam, MD, PhD · Principal investigator
    • Sidharth Puram, MD, PhD · Principal investigator
    • Douglas R Adkins, MD · Sub investigator
    • Anthony J Apicelli, MD, PhD · Sub investigator
    • Christine Auberle, MD · Sub investigator
    • Jennifer De Los Santos, MD · Sub investigator
    • Hiram Gay, MD · Sub investigator
    • Lannis Hall, MD, MPH · Sub investigator
    • Yao Hao, PhD · Sub investigator
    • R Alex Harbison, MD, MS · Sub investigator
    • Ryan S Jackson, MD · Sub investigator
    • Brendan J Knapp, MD · Sub investigator
    • Esther Lu, PhD · Sub investigator
    • Daniel Miller, MD, PhD · Sub investigator
    • Peter Oppelt, MD · Sub investigator
    • Patrick Pipkorn, MD · Sub investigator
    • Nikhil Rammohan, MD, PhD · Sub investigator
    • Jason T Rich, MD · Sub investigator
    • Robert D Siegel, MD · Sub investigator
    • Wade L Thorstad, MD · Sub investigator
    • Gregory R Vlacich, MD, PhD · Sub investigator
    • Jesse Zaretsky, MD, PhD · Sub investigator
    • Paul Zolkind, MD · Sub investigator
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Start date
Sep 30, 2026→Nov 30, 2026
Nov 3, 2026
Primary completion
Nov 30, 2028→Jan 31, 2029
Nov 3, 2026
Study completion
Nov 30, 2033→Jan 31, 2034
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Start date Sep 30, 2026→Nov 30, 2026
    Primary completion Nov 30, 2028→Jan 31, 2029
    Study completion Nov 30, 2033→Jan 31, 2034
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07552558
Collaborators
Bicara Therapeutics
Responsible party
Sponsor
First posted
Apr 27, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Jan 31, 2029 (estimated)
Completion
Jan 31, 2034 (estimated)
Last update
Nov 3, 2026

Study contacts

Sana Karam, MD, PhD
Contact
sanadkaram@wustl.edu
314-362-9700
Sidharth Puram, MD, PhD
Contact
sidpuram@wustl.edu
314-362-9700
Sana Karam, MD, PhD
principal investigator · Washington University School of Medicine
Sidharth Puram, MD, PhD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ficerafusp alfa

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