Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer

Conditions

• Advanced or Metastatic Breast Cancer (BC)
• Advanced or Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Trastuzumab emtansine (T-DM1) — DRUG
  Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate (ADC) consisting of the humanized anti-HER2 monoclonal antibody trastuzumab covalently linked to the cytotoxic maytansinoid DM1 via a non-cleavable thioether linker (SMCC). T-DM1 is administered intravenously at a dose of 3.6 mg/kg every 3 weeks (Q3W).
• Trastuzumab deruxtecan (T-DXd) — DRUG
  Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) consisting of the humanized anti-HER2 monoclonal antibody trastuzumab covalently linked to the topoisomerase I inhibitor payload DXd via a cleavable tetrapeptide-based linker (GGFG). T-DXd is administered intravenously at a dose of 5.4 mg/kg every 3 weeks (Q3W).
• Datopotamab deruxtecan (Dato-DXd) — DRUG
  Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate (ADC) consisting of a humanized anti-TROP2 IgG1 monoclonal antibody covalently linked to the topoisomerase I inhibitor payload DXd via a cleavable tetrapeptide-based linker (GGFG). Dato-DXd is administered intravenously at a dose of 6 mg/kg every 3 weeks (Q3W).
• Sacituzumab govitecan (SG) — DRUG
  Sacituzumab govitecan (SG) is an antibody-drug conjugate (ADC) consisting of a humanized anti-TROP2 IgG1 monoclonal antibody covalently linked to the topoisomerase I inhibitor payload SN-38 via a cleavable pH-sensitive carbonate linker (CL2A). SG is administered intravenously at a dose of 10 mg/kg on Days 1 and 8 of each 21-day cycle.
• Enfortumab vedotin (EV) — DRUG
  Enfortumab vedotin (EV) is an antibody-drug conjugate (ADC) consisting of a humanized anti-Nectin-4 IgG1 monoclonal antibody covalently linked to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a cleavable protease-sensitive linker (vc, valine-citrulline). EV is administered intravenously at a dose of 1.25 mg/kg on Days 1, 8, and 15 of each 28-day cycle.
• Becotatug vedotin (MRG003) — DRUG
  Becotatug vedotin (MRG003) is an antibody-drug conjugate (ADC) consisting of a humanized anti-EGFR IgG1 monoclonal antibody covalently linked to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a cleavable protease-sensitive linker (vc, valine-citrulline). MRG003 is administered intravenously every 3 weeks (Q3W).
• Izalontamab brengitecan (iza-bren / BL-B01D1) — DRUG
  Izalontamab brengitecan (iza-bren; BL-B01D1) is a bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3, covalently linked to a topoisomerase I inhibitor payload. BL-B01D1 is administered intravenously.
• Mirvetuximab soravtansine (MIRV) — DRUG
  Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate (ADC) consisting of the humanized anti-FRα monoclonal antibody M9346A covalently linked to the cytotoxic maytansinoid DM4 via a cleavable disulfide linker. MIRV is administered intravenously at a dose of 6 mg/kg adjusted ideal body weight (AIBW) on Day 1 of every 3-week cycle (Q3W).

Study Details

To evaluate the clinical efficacy (objective response rate, ORR) of mass spectrometry-based absolute quantification-guided selection and matching of ADC/PDC therapy in patients with locally advanced or metastatic pancreatic cancer/breast cancer, and to explore a quantitative threshold-based stratification strategy for identifying a "hidden benefit population

Key Dates

First listed

Sep 17, 2026

Start date

Sep 10, 2026

Status verified

Sep 2026

Primary completion

Sep 1, 2027

Completion

Feb 1, 2030

Study Design

Enrollment

225 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: HER2-directed molecular cohort
  Participants with elevated HER2 protein expression, as assessed by membrane protein assay, were treated with HER2-directed antibody-drug conjugates (ADCs), such as trastuzumab emtansine (T-DM1) or trastuzumab deruxtecan (T-DXd).
• Experimental: TROP2-directed molecular cohort
  Participants with elevated TROP2 protein expression, as assessed by membrane protein assay, were treated with TROP2-targeted antibody-drug conjugates (ADCs), such as datopotamab deruxtecan (Dato-DXd) or sacituzumab govitecan (SG).
• Experimental: Nectin-4-directed molecular cohort
  Participants with elevated Nectin-4 protein expression, as assessed by membrane protein assay, were treated with Nectin-4-targeted antibody-drug conjugates (ADCs), such as enfortumab vedotin (EV).
• Experimental: EGFR-directed molecular cohort
  Participants with elevated EGFR protein expression, as assessed by membrane protein assay, were treated with EGFR-targeted ADCs, including becotatug vedotin (MRG003), and EGFR/HER3 bispecific ADCs, such as izalontamab brengitecan (iza-bren).
• Experimental: FRα-directed molecular cohort
  Participants with elevated FRα protein expression, as assessed by membrane protein assay, were treated with FRα-targeted ADCs, such as mirvetuximab soravtansine (MIRV).

Primary Outcome Measure

Objective Response Rate (ORR) as Assessed by RECIST 1.1 [ Time Frame: Up to 104 Weeks ]

Central Contacts

• Jian Zhang, MD
  +8664175590
  [email protected]
• Yanchun Meng, MD
  +8664175590
  [email protected]