Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0GCCJJ
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| ADC Name |
Tecotabart vedotin
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| Synonyms |
tecotabart vedotin; LM-302; TPX-4589
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| Organization |
LaNova Medicines (Originator);Turning Point Therapeutics (Top20 MNC) (No Rights)
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
Tecotabart
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Antibody Info | ||||
| Antigen Name |
Claudin-18.2 (CLDN18.2)
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Antigen Info | ||||
| Payload Name |
Monomethyl auristatin E
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Mc-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
vedotin
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| Special Approval(s) |
Orphan drug (FDA)
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2027 Update
The indication landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Indication | Phase 1 | Phase 2 | Phase 3 | Approved | |||||
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| Unspecific solid tumor |
1 Trials
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2 Trials
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| Oesophageal cancer |
1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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1 Trials
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| Gastric cancer |
1 Trials
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1 Trials
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| Colorectal cancer |
1 Trials
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| Pancreatic cancer |
1 Trials
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| Biliary tract cancer |
1 Trials
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1 Trials
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| Ovarian cancer |
1 Trials
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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 | Progression Free Survival |
7.16 months
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| Patients Enrolled |
Key inclusion criteria: fully informed consent; age 18-80; ECOG 0-1; life expectancy ≥3 months; histologically/cytologically confirmed CLDN18.2-positive advanced solid tumors (IHC by central lab) refractory to standard therapy; ≥1 evaluable (Phase I) or measurable (Phase II) lesion per RECIST v1.1; adequate organ/marrow function; ability to comply with study requirements.
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| Administration Dosage |
LM-302 Dose Escalation. 6 dose levels were pre-defined, and the initial accelerated titration followed by the i3+3 design was adopted during phase I.
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| Related Clinical Trial | |||||
| NCT Number | NCT05161390 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase I/II , Open, Multicentre, Dose-escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumour Activity of LM-302 in Patients With CLDN18.2 Positive Advanced Solid Tumours | ||||
| Primary Endpoint |
Primary safety endpoints include dose-limiting toxicity (DLT) assessment during Cycle 1 (21-day cycle), adverse events/serious adverse events monitoring per NCI CTCAE v5.0 from ICF signing until 28 days post-EOT, with determination of both recommended Phase II dose (RP2D) and maximum tolerated dose (MTD) within 21 days post-first dose.
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| Other Endpoint |
Pharmacokinetic analysis focuses on area under plasma concentration curve (AUC) for LM-302 through completion of cycle 5 (each cycle lasting 21 days) to evaluate drug exposure changes over time.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
30.60%
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| Patients Enrolled |
Key inclusion criteria: fully informed consent; age 18-80; ECOG 0-1; life expectancy ≥3 months; histologically/cytologically confirmed CLDN18.2-positive advanced solid tumors (IHC by central lab) refractory to standard therapy; ≥1 evaluable (Phase I) or measurable (Phase II) lesion per RECIST v1.1; adequate organ/marrow function; ability to comply with study requirements.
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| Administration Dosage |
LM-302 Dose Escalation. 6 dose levels were pre-defined, and the initial accelerated titration followed by the i3+3 design was adopted during phase I.
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| Related Clinical Trial | |||||
| NCT Number | NCT05161390 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase I/II , Open, Multicentre, Dose-escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumour Activity of LM-302 in Patients With CLDN18.2 Positive Advanced Solid Tumours | ||||
| Primary Endpoint |
Primary safety endpoints include dose-limiting toxicity (DLT) assessment during Cycle 1 (21-day cycle), adverse events/serious adverse events monitoring per NCI CTCAE v5.0 from ICF signing until 28 days post-EOT, with determination of both recommended Phase II dose (RP2D) and maximum tolerated dose (MTD) within 21 days post-first dose.
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| Other Endpoint |
Pharmacokinetic analysis focuses on area under plasma concentration curve (AUC) for LM-302 through completion of cycle 5 (each cycle lasting 21 days) to evaluate drug exposure changes over time.
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| Experiment 3 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
75%
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| Patients Enrolled |
Key inclusion criteria: fully informed consent; age 18-80; ECOG 0-1; life expectancy ≥3 months; histologically/cytologically confirmed CLDN18.2-positive advanced solid tumors (IHC by central lab) refractory to standard therapy; ≥1 evaluable (Phase I) or measurable (Phase II) lesion per RECIST v1.1; adequate organ/marrow function; ability to comply with study requirements.
Click to Show/Hide
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| Administration Dosage |
LM-302 Dose Escalation. 6 dose levels were pre-defined, and the initial accelerated titration followed by the i3+3 design was adopted during phase I.
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| Related Clinical Trial | |||||
| NCT Number | NCT05161390 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase I/II , Open, Multicentre, Dose-escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumour Activity of LM-302 in Patients With CLDN18.2 Positive Advanced Solid Tumours | ||||
| Primary Endpoint |
Primary safety endpoints include dose-limiting toxicity (DLT) assessment during Cycle 1 (21-day cycle), adverse events/serious adverse events monitoring per NCI CTCAE v5.0 from ICF signing until 28 days post-EOT, with determination of both recommended Phase II dose (RP2D) and maximum tolerated dose (MTD) within 21 days post-first dose.
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| Other Endpoint |
Pharmacokinetic analysis focuses on area under plasma concentration curve (AUC) for LM-302 through completion of cycle 5 (each cycle lasting 21 days) to evaluate drug exposure changes over time.
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| Experiment 4 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible subjects must be CLDN18.2-positive GI cancer patients (18-80yo, ECOG 0-1, life expectancy ≥3 months) with ≥1 measurable lesion (RECIST v1.1) and adequate organ function, having provided informed consent prior to study procedures.
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| Administration Dosage |
LM-302 (recombinant humanized anti-CLDN18.2 monoclonal antibody, MMAE conjugate), Toripalimab (recombinant humanized anti-PD1 monoclonal antibody)
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| Related Clinical Trial | |||||
| NCT Number | NCT05934331 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II, Open-Label, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of LM-302 Combined With Toripalimab in CLDN18.2 Positive Patients Advanced Gastro-Intestinal Cancer | ||||
| Primary Endpoint |
Primary endpoint evaluates PFS per RECIST v1.1 criteria within 6 weeks post-first dose.
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| Other Endpoint |
Secondary endpoints assess ORR, DOR, DCR (CR+PR+SD), and OS during the same 6-week evaluation period.
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| Experiment 5 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients must have unresectable/metastatic BTC (histologically confirmed) with prior treatment failure (chemotherapy+PD1/PD-L1), measurable lesions (outside prior local therapy areas if applicable), ECOG≤2, life expectancy>3 months, and adequate organ function (Cr≤1.5×ULN/GFR≥60mL/min, bilirubin≤1.5×ULN, ALT/AST≤2.5×ULN, ANC>1500/mcl, Plts>75,000/mcl). Phase II requires Claudin18.2-positivity (≥40% IHC by dual-pathologist confirmation). HBV/HCV patients eligible with viral control (HBV<2000 IU/ml with antiviral therapy; HCV treated/completed therapy with stable LFTs).
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| Administration Dosage |
Each cycle of the first phase was defined as cardonilizumab (6mg/kg,Q2W) combined with different concentrations of 1.6mg/kg or 1.8mg/kg LM-302 (Q2W), 14 days as a course of treatment, and the combined dose (RP2D) of LM-302 during combination therapy was determined according to the 3+3 design.
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| Related Clinical Trial | |||||
| NCT Number | NCT05994001 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | Two Stage, Multi-center Trial of Candonilimab in Combination With LM-302 for Treatment of Patients With Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody | ||||
| Primary Endpoint |
Primary endpoints include ORR (RECIST 1.1) in Claudin18.2-positive patients receiving cardonilizumab+LM302 (Phase II) and treatment-emergent AE incidence in advanced BTC patients across LM-302 dose levels (Phase I), both evaluated over 24 months. Secondary efficacy endpoints assess DOR, DCR, and OS during the 24-month study period.
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| Other Endpoint |
Secondary efficacy endpoints assess DOR, DCR, and OS during the 24-month study period.
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| Experiment 6 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible patients are CLDN18.2-positive, HER2-negative G/GEJ adenocarcinoma patients (18-80yo, ECOG 0-1) with ≥1 measurable lesion (RECIST 1.1) who failed ≥2 systemic therapies (including adjuvant therapy relapsed within 6 months). Required: adequate organ function (hematologic/hepatic/renal/coagulation), life expectancy ≥12 weeks, and informed consent.
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| Administration Dosage |
LM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle
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| Related Clinical Trial | |||||
| NCT Number | NCT06351020 | Clinical Status | PHASE3 | ||
| Clinical Description | A Phase III, Open-Label, Multi Center, Randomized Study of LM-302 Versus Treatment of Physician's Choice (TPC) in Patients With CLDN18.2-Positive, Locally Advanced or Metastatic Gastric (GC) and Gastroesophageal Junction (GEJ) Adenocarcinoma. | ||||
| Primary Endpoint |
Primary endpoints assess OS (time from randomization to death) and PFS (time to radiographic progression/death) over 42 months, both based on investigator assessment.
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| Other Endpoint |
Secondary endpoints include ORR (CR+PR per RECIST 1.1), DoR (response duration to progression/death), DCR (CR+PR+SD≥6 weeks), AEs/SAEs (NCI-CTCAE v5.0), immunogenicity (ADA detection), and PK evaluations (Cmax/AUC/trough for LM-302, total antibody, and MMAE using PopPK modeling) across the 42-month study period.
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| Experiment 7 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Eligible participants are CLDN18.2-positive (IHC≥10%) gastric/GEJ adenocarcinoma patients (≥18yo, ECOG≤1) with unresectable/metastatic disease, ≥1 measurable lesion (RECIST 1.1), and life expectancy >3 months. Key requirements: prior adjuvant therapy completed ≥6 months pre-progression (oxaliplatin toxicity resolved to CTCAE v5.0 grade 1), adequate organ function (Cr≤1.5×ULN/GFR≥60mL/min, bilirubin≤1.5×ULN, AST/ALT≤2.5×ULN [≤5×ULN if liver mets], ANC≥1.5×109/L, PLT≥100×109/L), and signed informed consent
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| Administration Dosage |
1.8mg/kg ivgtt d1, q2w; Canonilimab: 6mg/kg ivgtt d1, q2w; Capecitabine: 1000mg/m^2 po bid d1-10, q2w.
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| Related Clinical Trial | |||||
| NCT Number | NCT06587425 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma | ||||
| Primary Endpoint |
Primary endpoints evaluate DLTs (Cycle 1 toxicities related to LM302) and PFS (time from randomization to progression/death) over a 42-month period, with investigator-assessed radiographic confirmation.
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| Other Endpoint |
Secondary endpoints include OS (time to death from any cause), ORR (CR+PR per RECIST 1.1), DoR (response duration until progression/death), DCR (CR+PR+SD≥6 weeks), and AE/SAE monitoring (NCI-CTCAE v5.0) through treatment completion plus 40 days follow-up.
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| Experiment 8 Reporting the Activity Date of This ADC | [6] | ||||
| Patients Enrolled |
Eligible patients must have histologically confirmed HER2-negative gastric adenocarcinoma with intact primary/metastatic lesions, laparoscopy-confirmed peritoneal metastases without obstruction, Claudin 18.2 positivity (≥25% expression in ≥50% tumor cells in ≥70% cases), age ≥18 years, ECOG ≤1, life expectancy >3 months, adequate bone marrow/hepatic/renal function, and provided written informed consent.
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| Administration Dosage |
LM-302 2.0mg/kg intravenous (IV) infusion on day 1, paclitaxel 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1 80 mg/m2 for 14 consecutive days every 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT06519591 | Clinical Status | PHASE2 | ||
| Clinical Description | Systemic Application of Cadonilimab, LM-302, and S-1 Combined With Intraperitoneal Infusion of Paclitaxel for the Treatment of Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis | ||||
| Primary Endpoint |
Primary endpoint evaluates 1-year survival rate at 12 months post-treatment.
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| Other Endpoint |
Secondary endpoints assess treatment-related adverse events over 24 months, 3-year overall survival (OS) at 36 months, and 3-year progression-free survival (PFS) at 36 months.
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| Experiment 9 Reporting the Activity Date of This ADC | [7] | ||||
| Patients Enrolled |
Eligibility requires signed informed consent, age ≥18, ECOG 0-1, life expectancy ≥3 months; Phase Ia accepts advanced solid tumors (gastric/GEJ, pancreatic, biliary, colorectal, ovarian, esophageal) regardless of CLDN18.2 status, while Phase Ib requires CLDN18.2+ tumors (IHC 1±3+ in ≥10% tumor cells, with ≥3 subjects having 2±3+ in ≥40% cells); All subjects need adequate organ function (PLT≥90×109/L, ANC≥1.5×109/L, Hb≥9g/dL, bilirubin≤1.5×ULN, AST/ALT≤2.5×ULN, Cr≤1.5×ULN or CrCl≥50mL/min, LVEF≥50%, QTcF≤480ms) and measurable disease (RECIST v1.1).
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| Administration Dosage |
Arm1:LM302 0.2 mg/kg i.v., QW×3 weeks group; Arm2:LM302 0.4 mg/kg i.v., QW×3 weeks group; Arm3:LM302 0.8 mg/kg i.v., QW×3 weeks group; Arm4:LM302 1.6 mg/kg i.v., QW×3 weeks group; Arm5:LM302 2.4 mg/kg i.v., QW×3 weeks group; Arm6:LM302 2.8 mg/kg i.v., QW×3 weeks group;
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| Related Clinical Trial | |||||
| NCT Number | NCT05001516 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I, First-in-Human, Open-Label, Dose Escalation and Expansion Study of TPX4589 in Patients With Claudin (CLDN)18.2-Positive Advanced Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints include dose-limiting toxicity (DLT) assessment during Cycle 1 (21-day cycle) and comprehensive safety evaluation through AE/SAE monitoring (NCI CTCAE v5.0) for 1 year post-dose, with vital signs (temperature, pulse, blood pressure), physical exams (weight), lab tests (hematology, biochemistry, urinalysis, coagulation), and ECG parameters (RR, QT, QRS intervals) being systematically tracked.
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| Other Endpoint |
Pharmacokinetic analysis includes AUCtau, Vss, Cmax, Cmin, Tmax, CL, T1/2 and dose proportionality assessments through intensive blood sampling over 1 year, along with efficacy evaluations (ORR, DOR, DCR, PFS per RECIST v1.1) and immunogenicity testing (ADA) at specified cycles.
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| Experiment 10 Reporting the Activity Date of This ADC | [8] | ||||
| Patients Enrolled |
Key inclusion criteria: signed ICF; age ≥18; ECOG 0-1; life expectancy ≥3 months; histologically confirmed advanced solid tumors refractory to standard therapy.
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| Administration Dosage |
LM-302 monotherapy dose escalation (part Ia). Accelerated titration combined with traditional 3+3 design will be used for monotherapy dose escalation (part Ia).
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| Related Clinical Trial | |||||
| NCT Number | NCT05188664 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM- 302 in Combination With Toripalimab in Patients With Advanced Solid Tumors | ||||
| Primary Endpoint |
Primary objectives include DLT assessment during Cycle 1 (21-day cycle) to evaluate safety of LM-302 combined with toripalimab in advanced solid tumors, along with determination of RP2D and OBD within 6 months, and MTD within 21 days post-dose. (No secondary endpoints specified).
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References