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ADC and SBRT for Recurrent/Metastatic Salivary Gland Carcinoma

ConditionsAdenoid Cystic Carcinoma of the Head and NeckSBRTAntibody-drug Conjugates
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

About this trial

This is a single-arm, single-center, exploratory clinical study. The study plans to enroll patients with recurrent or metastatic head and neck salivary gland carcinoma (HN-SGC) . The trial comprises two cohorts: Cohort 1 (adenoid cystic carcinoma, ACC) and Cohort 2 (non-ACC SGC). Patients in Cohort 1 will initially receive MRG003, an EGFR-targeted antibody-drug conjugate (ADC). Patients in Cohort 2 will initially receive either MRG003 (EGFR-ADC) or a TROP2-targeted ADC. The selection between these two ADC therapies for Cohort 2 will be determined by the investigator based on the expression levels of specific tumor surface receptors.

Tumor response will be assessed by imaging every 6 weeks (±7 days). Subjects who are assessed as having stable disease (SD) on two consecutive evaluations or who develop oligometastatic progression will receive stereotactic body radiation therapy (SBRT). Following SBRT, maintenance therapy with the original ADC will be continued.

Treatment discontinuation will be permitted due to disease progression, death, intolerable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or other protocol-specified reasons, whichever occurs first. After treatment completion, all subjects will enter a post-treatment phase for safety visits and survival follow-up. For subjects who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted during the post-treatment period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide written informed consent prior to the initiation of any study-specific procedures.

Male or female patients aged 18-80 years.

Histologically or cytologically confirmed head and neck squamous cell carcinoma or adenoid cystic carcinoma, expressing ADC-related targets (e.g., EGFR, TROP2), with evidence of recurrence and/or metastasis.

Patients must have experienced disease progression after first-line standard therapy or be deemed unsuitable for such therapy, and meet the following conditions: (1) For adenoid cystic carcinoma, first-line treatment should include anti-angiogenic agents (e.g., TKIs or monoclonal antibodies), chemotherapy, or patients are considered unsuitable for standard first-line therapy by the investigator (e.g., high bleeding risk, non-healing wounds); (2) For other salivary gland carcinomas, patients must have progressed after first-line standard therapy or be unsuitable for such therapy.

Disqualifiers

Diagnosis of malignancies other than head and neck tumors within 5 years prior to the first dose (except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ following curative resection).

Participation in another interventional clinical study or receipt of investigational drugs/devices within 4 weeks prior to the first dose.

Prior treatment with ADC agents.

Treatment of traditional Chinese medicines with antitumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukins; except for local use for pleural effusion control) within 2 weeks prior to the first dose.

Trial design

Design model

Single group

Treatments tested in this trial

  • Becotatug Vedotin

    Drug

    The initial dosage is 2.3 mg/kg, administered intravenously every three weeks per treatment cycle. A single dose reduction level (Level 1) to 2.0 mg/kg is permitted based on predefined criteria; the specific dose reduction scheme is detailed in the study protocol.

  • SBRT

    Radiation

    The specific SBRT dose and fractionation will be determined based on the lesion site and prior history of radiation therapy. The standard dose range for SBRT will be 14 Gy-36 Gy, administered over 4-6 fractions (for example, 3.7 Gy per fractionfor 4 fractions). Adjustments to the dose and fractionation schedule maybe made according to individual patient needs and prior treatments.

  • Becotatug Vedotin or Sacituzumab Tirumotecan

    Drug

    Becotatug Vedotin (MRG003): The initial dosage is 2.3 mg/kg, administered intravenously every three weeks per treatment cycle. A single dose reduction level (Level 1) to 2.0 mg/kg is permitted based on predefined criteria; the specific dose reduction scheme is detailed in the study protocol. Sacituzumab Tirumotecan (SKB264): The initial dosage is 5 mg/kg, administered intravenously every two weeks. A single dose reduction level (Level 1) to 4 mg/kg is permitted based on predefined criteria; the specific dose reduction scheme is detailed in the study protocol.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Cohort 1 (ACC)Experimental treatment 2 interventions
Group B: Cohort 2 (non-ACC SGC)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

the proportion of patients with a reduction in tumor volume of a predefined amount and for a minimum time period, including complete response (CR) and partial response (PR) cases

Time frame
1-year

Secondary outcomes

1

Time to Response (TTR)

the interval from the date of treatmentinitiation (typically the first dose) to the date of the firstdocumented objective response (complete response \[CR\] or partial response \[PR\]). * TTR1 (Onset of response to ADC): Defined as the time from initiationof antibody-drug conjugate (ADC) therapy to the first occurrence of an objective response(PR or CR). This metric reflects the initial onset of action of the ADC, whether administeredas monotherapy or as part of a combination regimen. * TTR2(Onset of response to the overall combination therapy): Defined as the time from initiation of the fullcombination treatment regimen (i.e., after receivingADC therapy and completing the first course of SBRT) to the first occurrence of an objective response. This endpoint evaluates the onset of efficacy ofthe combination therapy as an integrated treatment approach.

Time frame
1-year
2

Disease Disease Control Rate (DCR)

Proportion of patients with a best overall response of confirmed CR, PR, or SD (SD must be confirmed at least 4 weeks after initial documentation).

Time frame
1-year
3

Progression-Free Survival (PFS)

Time from first treatment to disease progression or death from any cause, whichever occurs first.

Time frame
1-year
4

Overall Survival (OS)

Time from first treatment to death from any cause.

Time frame
1-year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Lead sponsor

Source ClinicalTrials.gov

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