Payload Information
General Information of This Payload
| Payload ID | PAY0TNTMU |
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|---|---|---|---|---|---|---|
| Name | TOP1 inhibitor |
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| Target | DNA topoisomerase 1 (TOP1) | |||||
Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
JSKN-016 [Phase 3]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent; age ≥18; ECOG 0-1; life expectancy ≥3 months; histologically confirmed advanced NSCLC (EGFRmut/negative) refractory to standard therapies; ≥1 measurable lesion (RECIST 1.1); available tumor tissue; adequate organ function; contraception agreement.
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| Related Clinical Trial | |||||
| NCT Number | NCT06775483 | Phase Status | PHASE2 | ||
| Clinical Description |
Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance: a Phase II Clinical Study
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| Primary Endpoint |
Primary endpoints include investigator-assessed ORR (CR+PR per RECIST v1.1) and AE incidence for safety evaluation, both measured over 24 months.
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| Other Endpoint |
Secondary endpoints comprise DOR, DCR, TTR, PFS (per RECIST v1.1), OS, PK parameters (Cmax, AUC, Tmax of JSKN016), and ADA incidence, all evaluated within 24 months.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent; age 18-75; ECOG 0-1; life expectancy ≥3 months; histologically confirmed advanced NSCLC ineligible for curative treatment; ≥1 measurable lesion (RECIST 1.1); available tumor tissue; adequate organ function; contraception agreement.
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| Related Clinical Trial | |||||
| NCT Number | NCT06868732 | Phase Status | PHASE1 | ||
| Clinical Description |
Evaluation of JSKN016 Combination Therapy in Subjects with Advanced Non-Small Cell Lung Cancer: a Phase Ib Study
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| Primary Endpoint |
Primary endpoints include investigator-assessed ORR (CR+PR per RECIST v1.1) and AE incidence for safety evaluation, both measured over 24 months.
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| Other Endpoint |
Secondary endpoints comprise efficacy measures (DOR, DCR, TTR, PFS, OS per RECIST v1.1), PK parameters (Cmax, Cmin of ADC components), and ADA assessment, all evaluated within 24 months.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent; age ≥18; advanced/metastatic epithelial malignancies (AGA+ NSCLC/HER2 IHC0 BC) refractory to standard therapy; ≥1 measurable lesion (RECIST 1.1); ECOG 0-1; life expectancy ≥3 months; adequate organ function; LVEF ≥50%; contraception compliance; biomarker requirements (e.g., EGFR/ALK mutations for NSCLC).
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| Related Clinical Trial | |||||
| NCT Number | NCT06592417 | Phase Status | PHASE1 | ||
| Clinical Description |
To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors
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| Primary Endpoint |
Primary endpoints include DLT incidence (21-day post-first dose), safety profile (TEAE/TRAE/SAE incidence up to 30 days post-last dose), lab abnormalities, MTD/RP2D determination, and ORR assessment (RECIST v1.1) within 1 year post-last dose.
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| Other Endpoint |
Secondary endpoints comprise CBR (CR+PR+SD≥6 months), PK parameters (Cmax, Tmax, AUC, t1/2), and DOR evaluation, all measured within 1 year post-last dose or 90 days post-treatment.
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SKB410 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible patients must have advanced solid tumors (RECIST 1.1 measurable), ECOG 0-1, and adequate organ function. Key exclusions include active inflammatory bowel disease, uncontrolled cardiovascular/CNS conditions, recent anticancer therapies (within 2-4 weeks), active HBV/HCV/HIV co-infections (unless controlled), or symptomatic effusions requiring drainage.
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| Administration Dosage |
Participants receive MK-3120 at dose level 1/2 as per the schedule specified in the arm.
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| Related Clinical Trial | |||||
| NCT Number | NCT06818643 | Phase Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors
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| Primary Endpoint |
The primary safety outcomes include incidence of adverse events (AEs) and treatment discontinuations due to AEs over ~30 months, capturing all medically significant occurrences regardless of causality.
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| Other Endpoint |
Efficacy measures assess objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) per RECIST 1.1 over ~34 months, alongside pharmacokinetic parameters (AUC, Cmin, Cmax) of MK-3120 monitored for ~4 months.
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| Experiment 2 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Eligible participants must be ≥18 years with advanced solid tumors (RECIST v1.1 measurable), ECOG 0-1, and adequate organ function. Key exclusions include recent anti-tumor therapies (within 4 weeks/5 half-lives), active CNS metastases, uncontrolled cardiovascular/autoimmune diseases, HIV/active hepatitis infections, pregnancy/lactation, or prior stem cell/organ transplantation.
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| Administration Dosage |
SKB410 for injection is administered every 2 weeks (q2w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
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| Related Clinical Trial | |||||
| NCT Number | NCT05906537 | Phase Status | PHASE1 | ||
| Clinical Description |
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SKB410 for Injection in Subjects with Advanced Solid Tumors
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| Primary Endpoint |
Phase Ia evaluates dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) within 28 days post-treatment initiation, while Phase Ib assesses objective response rate (ORR) per RECIST v1.1 over approximately 2 years.
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PHN-010 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [6] | ||||
| Patients Enrolled |
Key eligibility: Adults with progressive CRC/ovarian/endometrial/cervical/NSCLC cancers after ≥1 prior therapy, measurable disease, ECOG 0-1. Major exclusions: prior topoisomerase-1 ADC treatment, uncontrolled CNS metastases, Grade >1 residual toxicity, active infections/NIP-ILD, or recent anticancer therapies/surgeries.
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| Administration Dosage |
PHN-010 is administered intravenously.
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| Related Clinical Trial | |||||
| NCT Number | NCT06457997 | Phase Status | PHASE1 | ||
| Clinical Description |
First-in-Human, Phase 1b Study of PHN-010, an Antibody Drug Conjugate, in Patients with Advanced Solid Tumors
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| Primary Endpoint |
Primary endpoints include DLT incidence (Phase 1a, 18 months), AE/SAE monitoring (Phase 1a/1b, 18 months), dose modification frequency (18 months), and ORR assessment (Phase 1b, 36 months) in advanced solid tumors.
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| Other Endpoint |
Secondary objectives encompass efficacy measures (BOR, DCR, PFS, TTR, OS, CA-125 response, 36 months), comprehensive PK analysis (Cmax/Tmax/AUC/t1/2 for ADC components, 36 months), and immunogenicity (ADA concentration, 36 months).
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BG-C9074 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [7] | ||||
| Patients Enrolled |
Eligible participants (ECOG ≤1) have advanced solid tumors (measurable per RECIST v1.1), adequate organ function, and archived tumor tissue. Exclusions: prior B7H4-ADC/TOP1i-ADC therapy, active CNS metastases (<2cm/stable ≥4 weeks allowed), concurrent malignancies, ≥Grade 2 pneumonitis, uncontrolled infections, or diabetes. Contraception is required during and post-treatment (7 months for females, 4 months for males).
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| Related Clinical Trial | |||||
| NCT Number | NCT06233942 | Phase Status | PHASE1 | ||
| Clinical Description |
Phase 1a/1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
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| Primary Endpoint |
Phase 1a evaluates safety (AE/SAE incidence), determines MTD/MAD of BG-C9074 (±tislelizumab), and establishes RDFE based on toxicity, PK/PD, and antitumor activity. Phase 1b assesses ORR by RECIST v1.1 and RP2D selection, with both phases spanning ~3 years of follow-up.
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| Other Endpoint |
Secondary endpoints include ORR, DOR, DCR, CBR (confirmed CR/PR/SD ≥24 weeks), and PFS per RECIST v1.1. PK parameters (Cmax, Cmin, Tmax, t½, AUC, CL/F, Vz/F, accumulation) and immunogenicity (ADA) are analyzed over ~3 years, with intensive sampling in the first 4 months.
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HLX42 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [8] | ||||
| Patients Enrolled |
Eligible participants (18-75 years) must have confirmed advanced/metastatic solid tumors, measurable lesions per RECIST 1.1, ECOG 0-1, and adequate organ function. Exclusions include recent malignancies, uncontrolled ILD, allergies to study drug components, active infections, poorly managed cardiovascular issues, immunosuppressive therapy, or hepatic dysfunction (except Child-Pugh A in HCC). Pregnant/nursing women or those deemed unsuitable by investigators are excluded.
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| Administration Dosage |
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until progressive disease (PD) without any clinical benefit, initiation of other anti-tumor therapies, death, intolerable toxicity, or withdraw the informed consent (whichever occurs first).
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| Related Clinical Trial | |||||
| NCT Number | NCT06210815 | Phase Status | PHASE1 | ||
| Clinical Description |
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX42 (Anti-EGFR ADC) in Patients With Advanced/Metastatic Solid Tumors
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| Primary Endpoint |
The study evaluates HLX42's Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) within 21 days post-first administration. DLT includes drug-related AEs impacting dose escalation, while MTD is the highest dose where ≤1 of 6 patients experience DLT.
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| Other Endpoint |
Primary and secondary endpoints include Objective Response Rate (ORR), Duration of Response (DOR), Progression-Free Survival (PFS), and Overall Survival (OS) over approximately 24 months. Pharmacokinetic measures (Cmax, Tmax, T1/2) are assessed within 21 days, alongside immune responses (ADA, Nab incidence/titer). Treatment-emergent adverse events are monitored until 90 days post-last dose.
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References