General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0WGVKF
ADC Name
Recombinant anti-HER2 humanized mAb-DM1
Synonyms
Recombinant anti-HER2 humanized mAb-DM1; FS-1502; FS1502; FS 1502
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Organization
Qilu Pharmaceutical Co., Ltd.
Drug Status
Phase 1
Antibody Name
Undisclosed
Antigen Name
Receptor tyrosine-protein kinase erbB-2 (ERBB2)
 Antigen Info 
Payload Name
Mertansine DM1
 Payload Info 
Therapeutic Target
Microtubule (MT)
 Target Info 
Linker Name
Undisclosed
Conjugate Type
Random conjugation through nucleophilic lysines.
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 5 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT05238831
EARLY_PHASE1
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT)
Undisclosed  NCT05755048
PHASE3
A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study to Compare the Efficacy and Safety of FS-1502 Versus T-DM1 in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

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Undisclosed  NCT06439693
PHASE2
A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study:
Undisclosed  NCT05755048
PHASE3
A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study to Compare the Efficacy and Safety of FS-1502 Versus T-DM1 in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

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Undisclosed  NCT03944499
PHASE1
A Phase I,Multicenter,Open-label,Single-arm Study:A Dose-escalation Phase Evaluating FS1502 in Patients With HER2 Expressed Advanced Solid Tumors,and a Dose-expanded Phase in Patients With Local Advanced or Metastatic,HER2+ Breast Cancer

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Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 5 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Key eligibility: Adults (≥18) with progressive advanced sarcoma/prostate/breast/ovarian/pancreatic cancers (ECOG ≤2, life expectancy ≥6 months) post ≥1 prior therapy. Requires ACT Tumor Board recommendation, adequate organ function (ANC ≥1,500/uL, platelets ≥100,000/uL, bilirubin ≤1.5×ULN), and measurable disease. Major exclusions: active secondary malignancies, untreated CNS metastases, uncontrolled comorbidities (NYHA III-IV heart failure, severe infections), pregnancy/breastfeeding, or conditions jeopardizing protocol compliance.

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Administration Dosage
Administered in monotherapy or in combination with other targeted agents or immunotherapies, chemotherapies, or radiation. Combination treatment plans may include a two-week monotherapy lead-in, followed by a combination treatment regimen. Each ACT study intervention must have an established RP2D determined in a prior clinical trial. Participants undergo a Pre-Treatment Biopsy, plus an On-Treatment Biopsy after two weeks on first dose of study drug (s) and prior to starting Cycle 2, regardless of regimen. Participants continue to receive study agent (s) after the On-Treatment Biopsy, according to the biopsy results and the results of ongoing safety and clinical assessments. Treatment cycles repeat every 21 to 28 days in the absence of disease progression or unacceptable toxicity. Cycles are determined based on the study agent (s). Upon disease progression, participants are given the option to undergo an additional biopsy.

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Related Clinical Trial
NCT Number NCT05238831  Clinical Status EARLY_PHASE1
Clinical Description Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT)
Primary Endpoint
Primary endpoint evaluates feasibility of ACT therapy implementation, requiring ≥11/15 participants (80%) to initiate recommended regimen within 2 years, with protocol-specified analysis of barriers if threshold unmet.
Other Endpoint
Secondary objectives assess safety (CTCAE v5.0-graded AEs, discontinuation rates), efficacy (6-month ORR by RECIST 1.1/pseudoprogression criteria), and survival outcomes (PFS, disease-specific survival, OS) through 5-year follow-up using Kaplan-Meier/cumulative incidence methods.
Experiment 2 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Key eligibility: Adults (&ge;18) with HER2+ (IHC3+/FISH+) metastatic breast cancer (1-3 prior lines, ECOG 0-1). Exclusions: prior HER2-ADC use, active CNS metastases (except stable treated lesions), uncontrolled effusions/ILD, significant cardiac disease, QTc risks, active infections (HBV/HCV/HIV), or pregnancy. Requires adequate organ function (ANC &ge;1.0&times;10<sup>9</sup>/L, LVEF >50%) and measurable disease (RECIST 1.1).

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Administration Dosage
FS-1502 Dosage form: lyophilized powder Specification: 30 mg/vial Dose: 2.3 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip.
Related Clinical Trial
NCT Number NCT05755048  Clinical Status PHASE3
Clinical Description A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study to Compare the Efficacy and Safety of FS-1502 Versus T-DM1 in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
Primary Endpoint
Primary endpoint evaluates PFS by independent central review (up to 28 months) in HER2+ metastatic breast cancer patients post-trastuzumab/taxane treatment, defined as time from enrollment to disease progression (≥20% target lesion increase per RECIST 1.1) or death.
Other Endpoint
Secondary objectives assess OS (time to death), ORR (confirmed CR+PR rates), DCR (CR+PR+SD), CBR (response lasting ≥24 weeks), DOR (response duration), and treatment-emergent AEs (NCI-CTCAE v5.0 graded) over 28 months.
Experiment 3 Reporting the Activity Date of This ADC [3]
Patients Enrolled
Key eligibility: Adults (&ge;18) with untreated HER2+ (IHC3+) metastatic breast cancer (ECOG 0-1, LVEF &ge;50%), no prior systemic therapy except THP within 6 weeks. Exclusions: prior invasive breast cancer treatment, uncontrolled cardiac/ILD conditions, active infections (unless controlled HIV/HBV/HCV), CYP2C8/3A4 modifiers use, or pregnancy. Requires adequate organ function and stable brain metastases if present.

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Administration Dosage
.
Related Clinical Trial
NCT Number NCT06439693  Clinical Status PHASE2
Clinical Description A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study:
Primary Endpoint
Primary endpoint evaluates 4-year Disease-Free Survival (DFS4) using Kaplan-Meier method in HER2+ metastatic breast cancer patients, measuring time from registration to disease progression/death/anti-cancer therapy resumption (excluding endocrine therapy), with censoring at last evaluation for progression-free survivors.
Other Endpoint
Secondary objectives assess median Overall Survival (OS), Objective Response Rate (ORR by RECIST 1.1), Grade 3-5 treatment-related toxicity (CTCAE v5.0), completion rates of sequential therapy parts (A: taxane/trastuzumab/pertuzumab; B: trastuzumab deruxtecan; C: T-DM1/tucatinib; D: trastuzumab/pertuzumab/tucatinib), and DFS4 by Minimal Residual Disease status over 54 months.

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Experiment 4 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Eligible patients (&ge;18 years) must have HER2+ disease (IHC3+ or IHC2+/FISH+), 1-3 prior lines (including adjuvant trastuzumab/taxane), ECOG 0-1, LVEF>50%, and adequate organ function. Key exclusions: prior HER2-ADC use, uncontrolled CNS metastases (unless stable &ge;6 months post-treatment), QTc prolongation risks, active HBV/HCV/HIV, or unresolved toxicity >CTCAE G1 (except alopecia/stable G2 neuropathy).

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Administration Dosage
Experimental: FS-1502 Dosage form: lyophilized powder Specification: 30 mg/vial Dose: 2.3 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip.
Related Clinical Trial
NCT Number NCT05755048  Clinical Status PHASE3
Clinical Description A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study to Compare the Efficacy and Safety of FS-1502 Versus T-DM1 in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
Primary Endpoint
The study evaluates PFS by ICR in HER2+ unresectable/metastatic breast cancer patients previously treated with trastuzumab/taxanes over 28 months, with PD defined as ≥20% target lesion increase per RECIST v1.1.
Other Endpoint
Key efficacy endpoints (OS, ORR, DCR, CBR, DOR) and safety (TEAEs per NCI-CTCAE v5.0) are assessed via ICR/investigator over 28 months, with ORR requiring confirmed CR/PR (CR=target lesion disappearance; PR=≥30% decrease).
Experiment 5 Reporting the Activity Date of This ADC [4]
Patients Enrolled
Eligible patients (&ge;18 years) have HER2+ advanced cancers (IHC3+ or IHC2+/FISH+), ECOG 0-1, LVEF>50%, with &ge;2 prior anti-HER2 lines. Key exclusions: CNS metastases, recent major surgery/RT (<4 weeks), QTc >470ms, active HBV/HCV/HIV, or unresolved toxicity >CTCAE G1 (except stable G2 alopecia/neuropathy). Tissue confirmation is mandatory for pivotal study participants.

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Administration Dosage
Phase Ia: Patients enrolled on the 1.2 and 2.0 regimens: FS-1502 monotherapy every 4 weeks with intravenous drip, 28 days as a cycle; Patients enrolled on the 3.0 regimens: starting from the 1.0mg/kg dose group, FS-1502 monotherapy every 3 weeks with intravenous drip, 21 days as a cycle; Phase Ib: FS-1502 monotherapy, the dose and frequency of administration for Stage Ib will be obtained according to Phase Ia (RP2D).

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Related Clinical Trial
NCT Number NCT03944499  Clinical Status PHASE1
Clinical Description A Phase I,Multicenter,Open-label,Single-arm Study:A Dose-escalation Phase Evaluating FS1502 in Patients With HER2 Expressed Advanced Solid Tumors,and a Dose-expanded Phase in Patients With Local Advanced or Metastatic,HER2+ Breast Cancer
Primary Endpoint
The Phase Ia study evaluates DLT (NCI-CTCAE v5.0) and determines MTD/RP2D for FS-1502. ORR (CR/PR per RECIST v1.1) is assessed by IRC in Phase Ib over ~2 years in HER2+ solid tumors with confirmed HER2 expression criteria.
Other Endpoint
Safety analyses include TEAEs (CTCAE v5.0), SAEs, and treatment discontinuations over ~3 years. Efficacy is measured by PFS (time to progression/death), OS (1-year rate), DOR (CR/PR to progression), and CBR (CR/PR/SD >6 mo). PK parameters (AUC, Cmax, tmax, T1/2, clearance) and anti-drug antibodies are also assessed.
References
Ref 1 SMMART Adaptive Clinical Treatment (ACT) Trial
Ref 2 FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Ref 3 The SAPPHO Study: A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
Ref 4 Phase 1 Study of FS-1502 in Patients With HER2 Expressed Advanced Solid Tumors and Breast Cancer.