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This include two parts, Stage 1 is a dose climbing study and Stage 2 is a dose extending study.
This study is a study of MAX-40279 in patients with advanced / metastatic solid tumors. This study include two Parts, the Part 1 will assess the safety and efficacy of the dose climbing level of MAX-40279, and recommend a dose extending level of MAX-40279 for stage 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAX40279-01+KN046 | Experimental | This is an open-label Phase I/II clinical study. Drug: Stage1: Dose1:MAX40279-01 (35mg BID)+KN046 ( 5mg/kg Q3Week) Drug: Stage1: Dose2:MAX40279-01( 50mg BID)+KN046 ( 5mg/kg Q3Week) Drug: Stage1: Dose3:MAX40279-01( 70mg BID)+KN046 ( 5mg/kg Q3Week) Drug: Stage2: Dose3:MAX40279-01( RP2D BID)+KN046 ( 5mg/kg Q3Week) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAX-40279-01: 50mg/70mg | Drug | [Stage 1]The starting dose of MAX-40279 was 35 mg BID, and three dose levels were initially set: 35 mg, 50 mg, and 70 mg administered twice daily (BID) continuously, and the dose of KN046 was 5 mg/kg as a fixed dose administered every 3 weeks. [Stage 2]When the RP2D dose is obtained in the dose-finding phase, the trial will enter the dose expansion phase. |
| Measure | Description | Time Frame |
|---|---|---|
| DLT | through study Stage1 completion,an average of 6 months | |
| Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) | through study Stage1 completion,an average of 6 months | |
| ORR | through study Stage2 completion,an average of 24 months | |
| PFS | through study Stage2 completion,an average of 24 months | |
| Adverse events (AEs), serious adverse events (SAEs) | through study Stage2 completion,an average of 24 months | |
| laboratory tests | through study Stage2 completion,an average of 24 months | |
| vital signs | through study Stage2 completion,an average of 24 months | |
| 12 ECG | through study Stage2 completion,an average of 24 months | |
| physical examination abnormalities | through study Stage2 completion,an average of 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs), serious adverse events (SAEs) | through study Stage1 completion,an average of 6 months | |
| Cmax | through study Stage1 completion,an average of 6 months | |
| Measure | Description | Time Frame |
|---|---|---|
| FGFR1OP2-related protein expression levels and mutations, PD-L1 and related inflammatory factors correlate with efficacy [Stage 1] | through study Stage1 completion,an average of 6 months | |
| FGFR1OP2-related protein expression levels and correlation of mutations, PD-L1, tumor mutation burden, and related inflammatory factors with efficacy.[ Stage 2] |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Peng, MD,Ph.D | Contact | 13917659695 | tpeng@maxinovel.com | |
| Zhengbo Song, MD,Ph.D | Contact | 0571-88122168 | songzb@zjcc.org.cn |
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| Anti-KN046 antibody (ADA |
| through study Stage1 completion,an average of 6 months |
| Duration of response (DOR) Overall survival (OS); Anti-KN046 antibody (ADA); Plasma concentrations of MAX-40279 and KN046 [Stage 2] | through study Stage2 completion,an average of 24 months |
| (AUC0-t and AUC0-t, ss) | through study Stage1 completion,an average of 6 months |
| Tmax | through study Stage1 completion,an average of 6 months |
| Overall response rate (ORR) | through study Stage1 completion,an average of 6 months |
| disease control rate (DCR) | through study Stage1 completion,an average of 6 months |
| duration of response (DOR) | through study Stage1 completion,an average of 6 months |
| progression-free survival (PFS) | through study Stage1 completion,an average of 6 months |
| overall survival (OS) | through study Stage1 completion,an average of 6 months |
| DcR | through study Stage2 completion,an average of 24 months |
| DoR | through study Stage2 completion,an average of 24 months |
| OS | through study Stage2 completion,an average of 24 months |
| Anti-KN046 antibody (ADA) | through study Stage2 completion,an average of 24 months |
| Rac (AUC0-t, ss/AUC0-t) | through study Stage1 completion,an average of 6 months |
| laboratory tests | through study Stage1 completion,an average of 6 months |
| vital signs | through study Stage1 completion,an average of 6 months |
| 12 ECG | through study Stage1 completion,an average of 6 months |
| physical examination abnormalities | through study Stage1 completion,an average of 6 months |
| through study Stage2 completion,an average of 24 months |