Payload Information
General Information of This Payload
| Payload ID | PAY0UHCAF |
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| Name | AP052 |
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| Synonyms |
AP052
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| Target | Microtubule (MT) | |||||
Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
ADRX-0405 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Key eligibility comprises Phase 1a patients with advanced mCRPC/GC/NSCLC and Phase 1b with castration-resistant prostate cancer (testosterone <50ng/dL) failing SOC therapies, requiring measurable disease (RECIST 1.1 or PCWG3) and ECOG 0-1/0-2 status. Major exclusions include active CNS metastases, significant CVD, recent malignancies (<3 years), current ILD/pneumonitis, or active infections (prophylaxis allowed).
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| Administration Dosage |
Increasing doses of ADRX-0405 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part.
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| Related Clinical Trial | |||||
| NCT Number | NCT06710379 | Phase Status | PHASE1 | ||
| Clinical Description |
A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors
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| Primary Endpoint |
Primary safety evaluation focuses on adverse event monitoring throughout the 2-year study period for ADRX-0405 in advanced solid tumors including mCRPC, GC, and NSCLC, particularly in treatment-resistant mCRPC cases.
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| Other Endpoint |
econdary assessments include comprehensive PK profiling (Ceoi/Cmax, Ctrough, AUC, t1/2, CL, Vss), immunogenicity (ADA incidence), and efficacy metrics (ORR by RECIST 1.1/PCWG3, DOR, DCR, PFS, rPFS, OS) all measured over the 2-year study duration.
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ADRX-0706 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible subjects for Phase 1a (dose escalation) must have select advanced solid tumors (e.g., UC, HNSCC, NSCLC) progressing after ≥1 prior therapy, while Phase 1b (dose expansion) focuses on UC, TNBC, or cervical cancer. Exclusions include uncontrolled CNS metastases, significant cardiovascular disease, recent anticancer therapy (<14 days/5 half-lives), and concurrent CYP3A/P-gp modifiers.
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| Related Clinical Trial | |||||
| NCT Number | NCT06036121 | Phase Status | PHASE1 | ||
| Clinical Description |
A Phase 1a/b Study of ADRX-0706 in Subjects with Select Advanced Solid Tumors
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| Primary Endpoint |
The study will evaluate the incidence of adverse events over an estimated 3-year period, assessing safety throughout the trial duration.
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| Other Endpoint |
Pharmacokinetic parameters (Cmax, Ctrough, AUC, t1/2, CL, Vss) of ADRX-0706 and immunogenicity via anti-drug antibodies (ADA) will be measured serially over 3 years. Efficacy endpoints include ORR, DOR, DCR, PFS, and OS, all assessed per RECIST 1.1 criteria.
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References