Adenoid Cystic Carcinoma of the Head and NeckPhase 1AdCC_2023-01NCT05930951
Study of OBT076 Associated or Not in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma of the Head and Neck
A Phase 1 study testing OBT076 and Balstilimab in people with Adenoid Cystic Carcinoma of the Head and Neck, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
Trial summary
Adenoid cystic carcinoma (AdCC) is a rare salivary gland malignant tumor that accounts for approximately 1-3% of all head and neck cancers. AdCC is often charaterised by a long natural history with a propensity for indolent but relentless growth and dissemination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoid Cystic Carcinoma of the Head and Neck
- What is being tested?
- OBT076 and Balstilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2023to 9 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female ≥ 18 years
- ECOG PS 0-1
- Histologically confirmed Adenoid Cystic Carcinoma (AdCC) of the Head and Neck or trachea
- Histologically and/or radiologicaly documented recurrent or metastatic AdCC not amenable to surgery and/or radiotherapy
- Patients with confirmed disease progression at study entry. The screening radiological evaluation (CT/MRI of H\&N, chest, pelvis and brain if known or suspected cerebral involvement) should demonstrate disease progression according to RECIST 1.1 when compared to a prior disease assessment done within 6 months period prior to screening
- Measurable disease by CT scan or MRI according to RECIST 1.1 criteria
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- Adequate haematologic, renal and hepatic function as indicated by (using CTCAE v5.0):
- Absolute neutrophil count ≥ 2.0 × 109/L
- Platelets ≥ 100 × 109/L
- Hemoglobin ≥ 9.0 g/dL (blood transfusions during Screening are not permitted)
- White blood cells ≥ 2 000/mm3
- AST and ALT ≤ 2.5 × ULN in the absence of liver metastases or < 5 × ULN in the presence of liver metastases
- Serum creatinine < 1.5 × ULN
- Total bilirubin ≤ 1.5 × ULN (except Gilbert Syndrome < 3.0 mg/dL)
- Potassium within normal range according to local lab, or correctable with supplements
- The Investigator confirms that the participant agrees to use appropriate contraception and barriers methods, if applicable. The contraception, barrier, and pregnancy testing requirements are below:
- A female participant: i. Is not a WOCBP, no need serum pregnancy test or contraceptive method ii. If WOCBP, she must agree to use a highly effective contraceptive method (i.e., with a failure rate of < 1% per year), preferably with low user dependency (as described in section 3.3), from ICF signature (ICF of the study not ICF of prescreening) to at least 4 months after the last dose of study drug. WOCBP must not agree to donate eggs (ova, oocytes) for reproduction during this period.
- A male participant must agree to the following from ICF signature (ICF of the study not ICF of pre-screening) to at least 4 months after the last dose of study drug: i. To Refrain from donating fresh unwashed semen. If not done previously, cryopreservation of sperm prior to receiving study treatments is advised to male patients with a desire to have children. ii. Non-sterilized males who are sexually active with a female partner of childbearing potential must agree to use condom and spermicide. Because male condom and spermicide is not a highly effective contraception method, it is required that female partners of a male study participant use a highly effective contraceptive method (with a failure rate of < 1% per year).
- If participants are sexually active, they must agree to use a highly effective contraceptive method (i.e., with a failure rate of < 1% per year), preferably with low user dependency
- Patients with social insurance coverage
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the inform consent form and this protocol
Who cannot join
- Pretreatment with a programmed cell death protein (PD-1), PD-L1 or cytotoxic T- lymphocyte antigen 4 (CTLA-4) therapy or any other immuno-checkpoint inhibitors.
- Prior chemotherapy within 28 days before study drug administration.
- Prior systemic anticancer therapy (regardless if approved or investigational therapy) within 5 halflives of study drug administration
- Major surgery within 14 days before study drug administration
- Patients have not recovered from the toxicities (CTCAE v5.0 grade > 1) of prior anticancer therapy
- Prior curative radiotherapy ≤ 4 weeks or palliative radiotherapy ≤ 2 weeks before study drug administration, and/or from whom ≥ 30% of the bone marrow was irradiated
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- Patients with brain metastasis, except if treated with curative stereotactic radiotherapy
- History of another malignancy within the last 2 years prior to randomization, with the exception of completely resected non-melanoma cell skin cancer outside the head and neck area or completely resected stage I breast cancer, gleason 6 localised prostate cancer, or completely resected in-situ non-muscular invasive bladder, cervix and/or uterine carcinomas.
- Documented or suspected hypersensitivity or other contraindication to study drug or any excipients used in the manufacture of OBT076 or Balstilimab
- Active or chronic corneal disorder or Sjogren's syndrome
- Known history of infection with human immunodeficiency virus (HIV). If unknown history of HIV, an HIV screening test is to be performed and participants with positive serology for HIV-1/2 must be excluded.
- Known chronically active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Known active Covid 19 infection.
- Use of non-oncology vaccines containing live virus for prevention of infectious diseases within 28 days prior to study drug administration. The use of the inactivated seasonal influenza vaccine (Fluzone®) and covid vaccine is allowed.
- Active or prior history of disease/medical condition listed below:
- Known or underlying medical condition that, in the investigator's opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or adverse events
- Subject has a past medical history of or ongoing clinically relevant interstitial lung disease, drug-induced pneumonitis or severe / very severe Chronic Obstructive Pulmonary Disease (COPD).
- Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤10 mg daily prednisone equivalent), are permitted in the absence of active autoimmune disease
- Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e. with use of disease modifying agents or immunosuppressive drugs)
- Ongoing uncontrolled infection requiring intravenous antibiotics, or requiring/ongoing oral antibiotics as continuation of a prior IV antibiotic course, antivirals or antifungals within 7 days prior to randomization Note: patients with localized fungal infection of skin or nails are eligible
- Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following:
- Significant cardiac arrhythmia
- Unstable angina or angina requiring surgical or medical intervention within 6 months prior to randomization
- New York Heart Association Class > 2 congestive heart failure.
- QTc using Fridericia's formula (QTcF) interval > 470 ms
- Prior organ transplantation, including allogeneic stem cell transplantation
- Pregnant or breastfeeding women
- History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of drug administration.
- Patient under guardianship, curatorship or deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Study of OBT076 or OBT076 Followed by Balstilimab in Patients With Recurrent or Metastatic (R/M) Adenoid Cystic Carcinoma (AdCC) of the Head and Neck (H&N)
Adenoid cystic carcinoma (AdCC) is a rare salivary gland malignant tumor that accounts for approximately 1-3% of all head and neck cancers. AdCC is often charaterised by a long natural history with a propensity for indolent but relentless growth and dissemination. Local recurrences and late distant metastases are common findings in about 35% of the patients and associated with a poor prognosis1. AdCC is among the most lethal salivary gland tumors2 with no proven therapy for metastatic disease. Little is known about endogenous immune response directed against AdCC. However, in a relatively large series of 28 AdCC tumor, the immune profiling has shown in most tumors high and frequent programmed death ligand 2 (PD-L2) expression and PD-L1 was generally not expressed on tumor and infiltrating cells3.
The Antibody Drug Conjugates (ADCs) are emerging as a novel therapeutic option in cancer treatment that looks promising for solid tumors. An experimental CD205/Ly75-directed ADC, OBT076 induce potent cytotoxic and antitumor activity. Recently, the combination of immunohistochemistry (IHC) and tissue micro array (TMA) was performed in a series of 46 AdCC, showing a unique profile with both frequent and high expression of CD205/Ly75, much higher than for other solid tumors. In a phase I study, OBT076 demonstrated promising results for 3 patients with 2 partial responses and 1 complete response for a gastric cancer4. In this last patient, analysis showed an increase in PD1+, CD4+ and CD8+ cells suggesting that OBT076 activates the patient's immune response against the tumor, especially PD-1 targeted therapies4.
Based on this rational and on the high level of expression of CD205/Ly75 in AdCC, the hypothesis tested in this study is that OBT076 could be a potential effective treatment for R/M AdCC, which is an orphan lethal disease. The efficacy of OBT076 will be tested either alone or followed by an anti PD-1 inhibitor (Balstilimab) with the hypothesis that OBT076 will induce immune infiltrate that could restore sentivity to PD-1 targeting.
- Being tested
- OBT076, Balstilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBT076Drug
OBT076 is an ADC constituted by a fully human immunoglobulin 1 (IgG1) antibody directed against the CD205/Ly75 antigen (MBH1309), inducing potent cytotoxic and anti-tumor activity
BalstilimabDrug
Balstilimab is a human monoclonal antibody that targets programmed cell death protein 1 (PD-1).
| Study group | Role | What they receive |
|---|---|---|
| OBT076 only | Active comparator | OBT076, administration at 3mg/kg, (IV ≥ 3h infusion) on Day 1 every 21 days (3-week cycle) until disease progression, unacceptable toxicity, intercurrent conditions that preclude continuation of treatment or patient refusal whichever comes first. Receives: Drug: OBT076 |
| OBT076 -Balstilimab | Experimental | 3 cycles of OBT076, administration at 3mg/kg, IV (≥ 3h infusion) on Day 1 every 21 days (3-week cycle) followed by Balstilimab, administration at 450mg, IV, on Day 1 every 21 days (3-week cycle) until disease progression, unacceptable toxicity, intercurrent conditions that preclude continuation of treatment or patient refusal whichever comes first. Receives: Drug: OBT076; Drug: Balstilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR based on the best tumor response evaluated by investigator assessment using RECIST 1.1 criteria will be the primary endpoint
Measured: through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start29 Nov 2023
- Primary completion9 Oct 2024
- Study completion9 Oct 2024
Why it stopped: toxicity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid Cystic Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930951
- Sponsor's protocol ID
- 2023-503270-20-00
- Other IDs
- 2023
- Acronym
- AdCC_2023-01
- Status last verified
- May 2025
- First submitted
- 23 Jun 2023
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of OBT076 or OBT076 Followed by Balstilimab in Patients With Recurrent or Metastatic (R/M) Adenoid Cystic Carcinoma (AdCC) of the Head and Neck (H&N)
- ClinicalTrials.gov ID
- NCT05930951
- Acronym / sponsor ID
- AdCC_2023-01 / 2023-503270-20-00
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: toxicity
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adenoid cystic carcinoma (AdCC) is a rare salivary gland malignant tumor that accounts for approximately 1-3% of all head and neck cancers. AdCC is often charaterised by a long natural history with a propensity for indolent but relentless growth and dissemination. Local recurrences and late distant metastases are common findings in about 35% of the patients and associated with a poor prognosis1. AdCC is among the most lethal salivary gland tumors2 with no proven therapy for metastatic disease. Little is known about endogenous immune response directed against AdCC. However, in a relatively large series of 28 AdCC tumor, the immune profiling has shown in most tumors high and frequent programmed death ligand 2 (PD-L2) expression and PD-L1 was generally not expressed on tumor and infiltrating cells3.
The Antibody Drug Conjugates (ADCs) are emerging as a novel therapeutic option in cancer treatment that looks promising for solid tumors. An experimental CD205/Ly75-directed ADC, OBT076 induce potent cytotoxic and antitumor activity. Recently, the combination of immunohistochemistry (IHC) and tissue micro array (TMA) was performed in a series of 46 AdCC, showing a unique profile with both frequent and high expression of CD205/Ly75, much higher than for other solid tumors. In a phase I study, OBT076 demonstrated promising results for 3 patients with 2 partial responses and 1 complete response for a gastric cancer4. In this last patient, analysis showed an increase in PD1+, CD4+ and CD8+ cells suggesting that OBT076 activates the patient's immune response against the tumor, especially PD-1 targeted therapies4.
Based on this rational and on the high level of expression of CD205/Ly75 in AdCC, the hypothesis tested in this study is that OBT076 could be a potential effective treatment for R/M AdCC, which is an orphan lethal disease. The efficacy of OBT076 will be tested either alone or followed by an anti PD-1 inhibitor (Balstilimab) with the hypothesis that OBT076 will induce immune infiltrate that could restore sentivity to PD-1 targeting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OBT076 only | Active comparator | Drug: OBT076OBT076, administration at 3mg/kg, (IV ≥ 3h infusion) on Day 1 every 21 days (3-week cycle) until disease progression, unacceptable toxicity, intercurrent conditions that preclude continuation of treatment or patient refusal whichever comes first. |
| OBT076 -Balstilimab | Experimental | Drug: OBT076, Drug: Balstilimab3 cycles of OBT076, administration at 3mg/kg, IV (≥ 3h infusion) on Day 1 every 21 days (3-week cycle) followed by Balstilimab, administration at 450mg, IV, on Day 1 every 21 days (3-week cycle) until disease progression, unacceptable toxicity, intercurrent conditions that preclude continuation of treatment or patient refusal whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or Female ≥ 18 years
- ECOG PS 0-1
- Histologically confirmed Adenoid Cystic Carcinoma (AdCC) of the Head and Neck or trachea
- Histologically and/or radiologicaly documented recurrent or metastatic AdCC not amenable to surgery and/or radiotherapy
- Patients with confirmed disease progression at study entry. The screening radiological evaluation (CT/MRI of H\&N, chest, pelvis and brain if known or suspected cerebral involvement) should demonstrate disease progression according to RECIST 1.1 when compared to a prior disease assessment done within 6 months period prior to screening
Key exclusion criteria (29 listed)
- Pretreatment with a programmed cell death protein (PD-1), PD-L1 or cytotoxic T- lymphocyte antigen 4 (CTLA-4) therapy or any other immuno-checkpoint inhibitors.
- Prior chemotherapy within 28 days before study drug administration.
- Prior systemic anticancer therapy (regardless if approved or investigational therapy) within 5 halflives of study drug administration
- Major surgery within 14 days before study drug administration
- Patients have not recovered from the toxicities (CTCAE v5.0 grade > 1) of prior anticancer therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBT076OBT076 is an ADC constituted by a fully human immunoglobulin 1 (IgG1) antibody directed against the CD205/Ly75 antigen (MBH1309), inducing potent cytotoxic and anti-tumor activity | Drug | OBT076 -Balstilimab, OBT076 only |
| BalstilimabBalstilimab is a human monoclonal antibody that targets programmed cell death protein 1 (PD-1). | Drug | OBT076 -Balstilimab |
Primary outcome
Objective Response Rate (ORR)
Time frame: through study completion, an average of 1 year"
ORR based on the best tumor response evaluated by investigator assessment using RECIST 1.1 criteria will be the primary endpoint
Results and safety
The study was stopped early (reason given: toxicity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OBT076 and Balstilimab in people with Adenoid Cystic Carcinoma of the Head and Neck, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: toxicity). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: through study completion, an average of 1 year"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.