Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients. The're are two goals set in this study: one is to explore the safety and tolerability of KGX101 when mono and combo with envafolimab in Chinese patients, the other is to determine recommended phase 2 dose of KGX101 mono and combo with envafolimab. Participants will: 1. Take drug KGX101 mono or combo with envafolimab every 3 weeks; 2. Visit the clinic for checkups and tests. Schedule will be about 6-8 times in the first month and then about every 3 weeks afterwards.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KGX101 monotherapy-Dose level 1 | Experimental |
| |
| KGX101 monotherapy-Dose level 2 | Experimental |
| |
| KGX101 monotherapy-Dose level 3 | Experimental |
| |
| KGX101 monotherapy-Dose level 4 | Experimental |
| |
| KGX101 monotherapy dose expansion | Experimental |
| |
| KGX101 combo with Envafolimab-Dose level 1 | Experimental |
| |
| KGX101 combo with Envafolimab-Dose level 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KGX101 injection | Drug | KGX101 is a heterodimeric IL-12 prodrug with the C-terminus of IL-12 fused with ADCC-impaired IgG1 Fc and the N-terminus of IL-12 masked using the IL-12 binding domains of IL-12Rβ1 and IL-12Rβ2. KGX101 injection is a sterile, white or white-like lyophilized powder, supplied at 4.0 mg/vial for single use. |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of participants with adverse events | AE will be collected to assess participants' safety after KGX101 monotherapy or combo with Envafolimab | From baseline to 30 days after the last dose administration. |
| Number of participants with dose limiting toxicities/DLT within DLT observation period | DLT will be observed from start of the first priming dose of KGX101 until 21 days post the first target dose of KGX101 | From Day1 after the first priming dose of KGX101 until 21 days post the first target dose ofKGX101 |
| Number of participants with changes of clinical lab abnormalities | Any changes in values of the clinical chemistry, hematology, coagulation and urinalysis will be evaluated | From screening until 90 days post the last dose administration |
| The maximum tolerated dose of KGX101 monotherapy and combination therapy with Envafolimab | From Day 1 post the first dosing until 21 days post the the first target dosing |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: Maximum Concentration (Cmax) of total IL-12 | Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Guo | Contact | 13911233048 | guoj307@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Guo | Beijing Cancer Hopspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| KGX101 combo with Envafolimab-Dose level 3 | Experimental |
|
| KGX101 combo with Envafolimab dose expansion | Experimental |
|
|
| Envafolimab | Drug | Envafolimab is a novel fusion protein of humanized anti-PD-L1 single domain antibody and human IgG1 Fc fragment formulated for subcutaneous injection. |
|
| Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. |
| PK Parameters: Time of maximum observed concentration (Tmax)of total IL-12 | Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment. | Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. |
| PK Parameters: Area under the curve (AUC) | Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment. | Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. |
| PK Parameters: Half- life (T1 /2) | Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment. | Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. |
| PK Parameters- Trough concentration (Ctrough) | Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment. | Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. |
| PK Parameters- Systemic clearance (CL) | Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment. | Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. |
| PK Parameters- Volume of distribution (Vd) | Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment. | Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. |
| Immunogenicity- Anti-drug antibody (ADA) | Samples will be collected to assess the immunogeniccity after each KGX101 treatment. | Part A: From pre-dose of the first dose of KGX101 treatment until 90 days afrer the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until 90 days after the last dose. |
| Number of participants with changes in the Overall Response (ORR) | From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post the last treatment. |
| Progression free survival (PFS) per RECIST 1.1 | From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment. |
| Overall survival | From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment. |
| Fudan university Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
|
| ID | Term |
|---|---|
| C000718749 | envafolimab |
Not provided
Not provided
Not provided