Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0YQAIX
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| ADC Name |
Garetatug rezetecan
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| Synonyms |
garetatug rezetecan; SHR-A1904
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| Organization |
Jiangsu Hengrui Pharmaceuticals (Originator)
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
3.5 to 4.5
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| Structure |
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| Antibody Name |
Garetatug
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Antibody Info | ||||
| Antigen Name |
Claudin-18.2 (CLDN18.2)
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Antigen Info | ||||
| Payload Name |
SHR9265
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Mc-Gly-Gly-Phe-Gly
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
rezetecan
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||||||
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| Biliary tract cancer |
1 Trials
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| Gastric cancer |
1 Trials
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1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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1 Trials
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| Pancreatic cancer |
1 Trials
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1 Trials
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1 Trials
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| Unspecific solid tumor |
1 Trials
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General Information of The ADMET Data Related to This ADC(2027 Update)
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
36.7
55.6 % |
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| Patients Enrolled |
Eligible participants (18-75 years, ECOG 0-1, ≥3-month life expectancy, measurable lesions per RECIST v1.1, advanced solid tumors) exclude those with recent antitumor therapies, brain metastases, major surgeries, significant cardiac disease, or uncontrolled comorbidities as determined by investigators.
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| Administration Dosage |
During dose escalation, pts received SHR-A1904 at 0.6-8.0 mg/kg (Q3W IV) in an i3+3 design.
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| Related Clinical Trial | |||||
| NCT Number | NCT04877717 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Solid Tumors | ||||
| Primary Endpoint |
The study will determine the maximum tolerated dose (MTD) of SHR-A1904 over a 1-year period, establishing safety parameters for dose escalation.
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| Other Endpoint |
Pharmacokinetic assessments including Cmax, Tmax, AUC0-t, ADA formation, and ORR will be monitored throughout the 1-year study duration to evaluate drug exposure and immunogenicity.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants (18-75 years, ECOG 0-1, ≥3-month life expectancy, measurable lesions per RECIST v1.1) exclude those with recent antitumor treatments, major surgery, brain metastases, significant cardiac disease, or uncontrolled comorbidities per investigator judgment.
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| Administration Dosage |
.
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| Related Clinical Trial | |||||
| NCT Number | NCT04928625 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Pancreatic Cancer | ||||
| Primary Endpoint |
Phase 1 primary objectives include assessing DLT and MTD of SHR-A1904 within 2 months, followed by RP2D determination over 1 year.
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| Other Endpoint |
Pharmacokinetic parameters (Cmax, Tmax, AUC0-t), ADA formation, and ORR will be evaluated throughout the 1-year study duration.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients (18-75 years, ECOG 0-1, advanced pancreatic cancer with ≥1 measurable lesion, failed standard therapy) require adequate organ function; exclusions cover recent antitumor therapy, active CNS metastases, uncontrolled comorbidities, HIV/HBV/HCV infections, high pancreatitis risk, or major surgery within 28 days.
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| Administration Dosage |
SHR-A1904 will be administrated per dose level in which the patients are assigned.
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| Related Clinical Trial | |||||
| NCT Number | NCT06547736 | Clinical Status | PHASE2 | ||
| Clinical Description | A Single-center, Open-label, Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer | ||||
| Primary Endpoint |
The RP2D will be determined based on safety and efficacy data from dose escalation phases over approximately 12 months, with ORR assessed per RECIST v1.1 during the same period.
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| Other Endpoint |
Secondary endpoints include DCR, DOR, PFS (time to progression/death), OS (time to death/lost follow-up) all evaluated per RECIST v1.1 over 12 months, plus AEs monitored via NCI-CTCAE v5.0 from first dose to 90 days post-treatment.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible patients (18-75 years, ECOG 0-1, CLDN18.2+ gastric/GEJ adenocarcinoma) require measurable lesions and adequate organ function; exclusions include recent antitumor therapy, HER2 positivity, unresolved toxicities (>Grade 1), active CNS metastases, or severe cardiovascular/GI complications.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06649292 | Clinical Status | PHASE3 | ||
| Clinical Description | An Open, Randomized,Positive Control, Multicenter Phase III Clinical Study of SHR A1904 for Injection Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patients With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma | ||||
| Primary Endpoint |
The primary endpoint is overall survival (OS) measured from randomization until death from any cause, with assessment continuing for approximately 2 years.
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| Other Endpoint |
Secondary endpoints include investigator-assessed PFS (up to 1 year), ORR (CR+PR), DOR (time from first response to progression/death), DCR (CR+PR+SD), and AE/SAE incidence graded by CTCAE v5.0 (monitored until 90 days post-last dose).
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| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Eligible participants (18-75 years, ECOG 0-1, ≥12-week survival, RECIST v1.1 measurable lesions) exclude those with hypersensitivity to HRS-4642, recent surgeries/vaccines, active infections (HIV/hepatitis B/TB), uncontrolled cardiovascular/pancreatic/gastrointestinal conditions, or other high-risk comorbidities per investigator judgment.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06520488 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | Phase IB/II Clinical Study of the Safety, Tolerability and Efficacy of HRS-4642 in Combination With Anti-tumor Agents in Subjects With Advanced Solid Tumors | ||||
| Primary Endpoint |
The IB stage evaluates DLTs and AEs within 28 days post-first dose, while Phase II assesses investigator-evaluated ORR every 6 weeks over approximately 1 year.
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| Other Endpoint |
Both stages monitor ORR, with Phase II additionally tracking DCR, DoR, PFS, OS (assessed monthly), and AE incidence/severity, all evaluated at 6-week intervals over 1 year.
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| Experiment 6 Reporting the Activity Date of This ADC | [6] | ||||
| Patients Enrolled |
Eligible subjects must be >18, ECOG 0-1, Claudin 18.2-positive (≥50% 2+/3+ expression), and have adequate organ function; exclusions include recent major surgery, active infections, uncontrolled cardiovascular disease, prior anti-Claudin 18.2 therapy, or unresolved Grade >1 toxicities from prior treatments.
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| Administration Dosage |
It is a dose-escalation and dose-expansion study of SHR-A1904 in subjects with advanced solid tumors
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| Related Clinical Trial | |||||
| NCT Number | NCT05277168 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | AN OPEN-LABEL, SINGLE-ARM, MULTI-CENTER PHASE I/IIA CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS | ||||
| Primary Endpoint |
The study evaluates dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) within the first 21-day cycle, along with recommended Phase 2 dose (RP2D) based on Phase I results, while adverse events (AEs) and serious adverse events (SAEs) are monitored from informed consent until 90 days post-last dose.
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| Other Endpoint |
Key efficacy endpoints include objective response rate (ORR), duration of response (DoR), clinical benefit rate (CBR), progression-free survival (PFS), and overall survival (OS), assessed until study completion (~March 2026), with pharmacokinetic parameters (Tmax, Cmax) tracked up to 30 days post-last dose.
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| Experiment 7 Reporting the Activity Date of This ADC | [7] | ||||
| Patients Enrolled |
Eligible patients (18-75 years, ECOG 0-1, CLDN18.2-positive, measurable lesions) must have adequate organ function; exclusions include recent antitumor therapy, active infections, severe comorbidities (cardiovascular/autoimmune diseases, hepatitis/HIV), unresolved toxicities (>Grade 1), or gastrointestinal complications (e.g., perforation, bleeding).
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06350006 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase Ib/III Study of SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor | ||||
| Primary Endpoint |
The study assesses the incidence and severity of AEs over 24 months in Phase 1b, along with evaluating dose-limiting toxicity (DLT), maximal tolerable dose (MTD), and Phase III recommended dose (RP3D), while progression-free survival (PFS) by BICR is tracked for approximately 36 months in Phase 3.
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| Other Endpoint |
Immunogenicity (ADA, NAb), pharmacokinetics (SHR-A1904 toxin-binding/total antibody), and CLDN18.2 tumor expression are monitored over 24 months in Phase 1b, with overall survival (OS) and AE severity evaluated for around 36 months in Phase 3.
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| Experiment 8 Reporting the Activity Date of This ADC | [8] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05277168 | Clinical Status | Phase 1 | ||
| Clinical Description | An open-label, single-arm, multi-center phase 1/2a clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1904 in subjects with advanced solid tumors. | ||||
| Experiment 9 Reporting the Activity Date of This ADC | [9] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT04928625 | Clinical Status | Phase 1 | ||
| Clinical Description | An open-label, single-arm, multi-center phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1904 in patients with advanced pancreatic cancer. | ||||
| Experiment 10 Reporting the Activity Date of This ADC | [10] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT04877717 | Clinical Status | Phase 1 | ||
| Clinical Description | An open-label, single-arm, multi-center phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1904 in patients with advanced solid tumors. | ||||
References