This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerabili… (NCT06074497) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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.
Australia54 participantsStarted 2023-12-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Part A: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or for which no further standard therapy exists.
✓. Age at least 18 years.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1.
✓. Has at least 1 measurable lesion per RECIST 1.1 (lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions).
✓. Has adequate organ and bone marrow function as per the study (blood transfusion or use of use hematopoietic stimulating factor for correction within 14 days are not permitted):
✓. Hematologic: White blood cell (WBC) count ≥ 3 x 109/L; an absolute neutrophil count ≥ 1.5 x 109/L; a hemoglobin level \> 90 g/L; and a platelet count ≥ 100 x 109/L;
✓. Adequate hepatic function as defined by:
✓. Adequate renal function as defined by a serum creatinine ≤ 1.5 times the ULN concurrent with creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-- Gault equation);
Exclusion criteria
✕. Active known second malignancy with the exception of any of the following: adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer, breast cancer, papillary thyroid carcinoma; adequately treated stage I cancer from which the patient is currently in remission and has been in remission for ≥ 2 years; low risk prostate cancer with Gleason score \< 7 and prostate-specific antigen \<10ng/mL; any other cancer from which the patient has been disease-free survival for ≥ 5 years.
What they're measuring
1
Number of participants with Treatment emergent Adverse events (TEAEs)
Timeframe: From baseline to 30 days after the last dose administration.
2
Number of participants with Dose Limiting Toxicities (DLTs) at week 4
Timeframe: From Day 1 after the first dose of KGX101 full treatment to D21 post dose.
3
Number of participants with changes to clinical laboratory abnormalities
Timeframe: Screening to 90 days post last dose administration
4
To estimate the Maximum tolerated dose of KGX101 monotherapy and combination therapy with Envafolimab.
Timeframe: From Day 1 after the first dose of KGX101 full treatment to D21 post dose.
✕. A history of allogeneic tissue/solid organ transplant.
✕. Any evidence of severe or uncontrolled systemic diseases, including:
✕. Active, uncontrolled systemic bacterial, viral, or fungal infection;
✕. uncontrolled hypertension (Systolic blood pressure more than equal to 160mHG or diastolic blod pressure more than equal to 100mm HG or poor compliance with anti-hypertensive agents;
✕. or active bleeding diatheses;
✕. Clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (class III or IV of New York Heart Association \[NYHA\]) or acute myocardial infarction within 6 months;