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This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy With Envafolimab in Patients With Advanced or Metastatic Solid Tumors.
This is an open label, two-part, multicenter, multi-regional phase I trial to investigate the safety, tolerability, and PK of KGX101 monotherapy and combination therapy with Envafolimab in patients with advanced or metastatic solid tumors.
Study details:
This study will enrol 54 participants depending on the number of dose escalations needed. The study has 2 parts- Part A monotherapy dose escalation and Part B combination dose escalation. This study will assess KGX101 monotherapy (Part A) and in combination therapy with Envafolimab (Part B) by a standard 3+3 dose escalation design to identify the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).
This study schedule will include a 28-day screening, a DLT observation period, followed by variable length study treatment period, 90-day safety follow-up after the last treatment, and survival follow-up every 90 days. Therefore, the total duration of participation will vary for each participant depending on total doses. A priming dose is the initial lower dose(s) followed by escalation to the full treatment dose(s).
Priming dose will be implemented in all cohorts. As the first 3 enrolled previously participants at 0. 003 mg/kg didn't receive priming dose, the subsequent enrolled patients at this dose level will receive two priming doses before the target dose.
Two priming doses of KGX101 with an dosing interval of 10 days will be recommended. Priming dose regimen may be adjusted by Dose Escalation Committee (DEC) based on the real-time safety, available PK and PD data. The participants will receive KGX101 intravenous infusion at assigned escalating dose alone or in combined with 400mg Envafolimab every 3 weeks until disease progression or discontinuation criterion is met.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-12-13
Primary completion: 2026-05-30
Study completion finish: 2026-05-30
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06074497
Intervention or treatment
DRUG: KGX101- Cohort -1
DRUG: KGX101- Cohort 1
DRUG: KGX101- Cohort 2
DRUG: KGX101- Cohort 3
DRUG: KGX101- Cohort 4
DRUG: KGX101- Cohort 5
DRUG: KGX101 and Envafolimab
Conditions
- • Advanced or Metastatic Solid Tumors
Find a site
Closest Location:
Pindara Private Hospital
Research sites nearby
Select from list below to view details:
Pindara Private Hospital
Benowa, Queensland, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: KGX101- Cohort -1
| DRUG: KGX101- Cohort -1
|
EXPERIMENTAL: KGX101- Cohort 1
| DRUG: KGX101- Cohort 1
|
EXPERIMENTAL: KGX101- Cohort 2
| DRUG: KGX101- Cohort 2
|
EXPERIMENTAL: KGX101- Cohort 3
| DRUG: KGX101- Cohort 3
|
EXPERIMENTAL: KGX101- Cohort 4
| DRUG: KGX101- Cohort 4
|
EXPERIMENTAL: KGX101- Cohort 5
| DRUG: KGX101- Cohort 5
|
ACTIVE_COMPARATOR: KGX101 and Envafolimab
| DRUG: KGX101 and Envafolimab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of participants with Treatment emergent Adverse events (TEAEs) | TEAE will be collected to assess participants' safety after KGX101 treatment. | From baseline to 30 days after the last dose administration. |
Number of participants with Dose Limiting Toxicities (DLTs) at week 4 | DLT will be observed from start of treatment until 21 days post the first target dose treatment. | From Day 1 after the first dose of KGX101 full treatment to D21 post dose. |
Number of participants with changes to clinical laboratory abnormalities | Any changes in values of the clinical chemistry, hematology, coagulation and urinalysis will be evaluated. | Screening to 90 days post last dose administration |
To estimate the Maximum tolerated dose of KGX101 monotherapy and combination therapy with Envafolimab. | Not Specified | From Day 1 after the first dose of KGX101 full treatment to D21 post dose. |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
PK Parameters: Maximum Concentration (Cmax) | Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment) |
PK Parameters: Time of maximum observed concentration (Tmax) | Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment) |
PK Parameters: Area under the curve (AUC) | Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment) |
PK Parameters: Half- life (T1 /2) | Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment) |
PK Parameters- Trough concentration (Ctrough) | Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment) |
PK Parameters- Systemic clearance (CL) | Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment) |
Immunogenicity- Anti-drug antibody (ADA) | Samples will be collected to assess the immunogeniccity after KGX101 treatment. | Part A- From pre-dose of the first dose of KGX101 full treatment to Day 90 hours after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment) |
PK Parameters- Volume of distribution (Vd) | Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 hours after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment) |
Number of participants with changes in the Investigator-assessed confirmed Best Overall Response (BOR) | Not Specified | From Day 1 after the first dose of KGX101 full treatment to D21 post dose. |
Number of participants with changes in the Overall Response (ORR) | Not Specified | From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment. |
Progression free survival (PFS) per RECIST 1.1 | Not Specified | From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment. |
Overall survival | Not Specified | From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment. |
Change in serum concentration of KGX101 and total IL-12 | Not Specified | From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment. |
Frequently Asked Questions
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